Manufacturing & Production

GRAIL Inc

Senior Process Engineer - Compliance #4968

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the Bay Area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit [grail.com](<http://grail.com/>)

The Senior Process Engineer leads complex investigations, compliance related initiatives and supports document management processes. This role is primarily responsible for driving quality management system (QMS) activities across engineering, validation, clinical laboratory and operations, including change control management, SOP lifecycle oversight, nonconformance (NC) and CAPA metrics management, training compliance, and continuous process improvement. The Senior Process Engineer works across functions to design and implement process improvements, serve as a technical resource to peers and technicians, and ensure compliance with regulatory and quality requirements.

In addition, this role provides advanced technical expertise in high-complexity molecular diagnostic workflows supporting the Galleri® assay and collaborates cross-functionally to ensure operational excellence, regulatory readiness, and sustained compliance with applicable regulatory and accreditation requirements.

This position works full time onsite in Durham, NC.

**Responsibilities:**

- Lead and own quality management system (QMS) activities, including change controls, document control, SOP revisions, deviations/nonconformances (NCs), and corrective and preventive actions (CAPAs).
- Develop and maintain work instructions, guidelines, verifications, and standard operating procedures.
- Independently investigate and resolve process deviations, applying root cause analysis and implementing effective corrective and preventive actions.
- Support internal audits, external inspections, and regulatory assessments; prepare documentation, evidence packages, and responses to audit observations.
- Partner cross-functionally with Quality Assurance, Regulatory Affairs, Engineering Operations, Validation, and Clinical Operations leadership to implement and sustain compliant processes.
- Identify process gaps, compliance risks, and operational inefficiencies; recommend and implement sustainable corrective actions and process improvements.
- Mentor and train personnel on workflows, quality processes, and regulatory expectations.
- Provide technical guidance and support to engineers and technicians to promote process understanding and standardization.
- Prepare and present technical reports, proposals, and recommendations to management for process enhancements and cost savings.
- Develop training compliance processes, including assignment, completion tracking, and on the job training assessments.
- These job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.

**Required Qualifications:**

- Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, or related field) with 5+ years of relevant experience, or Master’s degree with 3+ years of relevant experience, or PhD with 2+ years of relevant experience.
- Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
  - GMP quality management systems (e.g. ISO 13485)
  - Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)
  - Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
- Experience supporting audits, inspections, and regulatory readiness activities.
- Proven ability to manage multiple priorities and drive projects to completion in a fast-paced regulated environment.

**Preferred Qualifications:**

- Strong working knowledge of quality management systems (QMS) and regulated laboratory/manufacturing operations.
- Expertise in change control, CAPA management, deviation/nonconformance investigations, and document control processes.
- Strong analytical and organizational skills with the ability to manage metrics, trend data, and compliance reporting.
- Excellent written and verbal communication skills, including technical writing and audit documentation.
- Strong collaboration and stakeholder management skills across cross-functional teams.
- Process improvement mindset with demonstrated success driving operational and quality improvements.
- Experience in executing within computerized maintenance/calibration equipment management systems.
- Excellent communication skills to influence and collaborate across departments and present technical findings.
- Leadership skills to mentor junior engineers and lead cross-functional teams.
- Strong project management and organizational skills; able to manage multiple workstreams with competing priorities

**Physical Demands and Work Environment:**

- Work performed in office, laboratory, and manufacturing production environments.
- Regular interaction with production equipment, requiring PPE such as safety glasses, gloves, lab coats, or cleanroom garments.
- Frequent standing, walking, and occasional lifting of 25–30 lbs.
- Exposure to chemicals, noise, and temperature variations in production areas.
- May require flexible hours, overtime, or weekend work to support production or project deadlines.

The expected, full-time, annual base pay scale for this position is $95k-$125k.

At GRAIL, we believe in recognizing and rewarding the contributions our employees make to our mission and success. In addition to base pay, this role may be eligible for additional compensation, including an annual bonus and/or other incentives, in accordance with applicable plans and the company's discretion. The posted range reflects our good-faith estimate of the base pay we expect to offer for this position at the time of hire. Actual compensation will be determined based on factors such as the candidate’s experience, skills, qualifications, and other relevant considerations.

At GRAIL, we invest in the health, well-being, and future of our employees and their families. Employees in this role are eligible for a comprehensive and competitive benefits package designed to support what matters most, including flexible time off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and thoughtfully selected well-being programs. Benefits are offered in accordance with applicable plans and policies.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at \[email protected\] if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

North Carolina

Dyne Therapeutics

Associate Director, Regulatory Operations - Veeva Vault RIM

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Associate Director, Regulatory Operations – Veeva Vault RIM is a key member of the Regulatory Operations team responsible for the business ownership, administration, governance, optimization, and ongoing evolution of Dyne’s Regulatory Information Management capabilities. This role serves as the primary subject matter expert for Veeva Vault RIM and partners with Regulatory Affairs, Quality, Information Technology, Clinical, CMC, Pharmacovigilance, vendors, and other stakeholders to ensure regulatory information, processes, and systems are accurate, compliant, scalable, and inspection ready.

This role translates regulatory and business needs into practical system solutions, establishes effective data and process governance, leads system enhancements and release readiness, and drives consistent adoption through clear standards, documentation, training, and user support. This individual will balance strategic planning with hands-on execution and will play an important role in building the regulatory infrastructure needed to support Dyne’s growing pipeline, global submissions, health authority interactions, and future commercialization.

This role is fully remote.

**Primary Responsibilities Include:**

*Veeva Vault RIM Business Ownership & Strategy*

- Serve as the business owner and primary subject matter expert for Dyne’s Veeva Vault RIM platform, including applicable capabilities supporting Registrations, Submissions, Submissions Archive, Publishing, Health Authority Interactions, Regulatory Objectives, commitments, reporting, and system administration
- Define and maintain a scalable RIM operating model, governance framework, enhancement roadmap, and system standards aligned with regulatory priorities, business needs, data integrity expectations, and the evolving needs of Dyne’s pipeline
- Partner with Regulatory Affairs leadership, Information Technology, Quality, system administrators, vendors, and business stakeholders to prioritize system capabilities, enhancements, integrations, and continuous improvement opportunities
- Translate regulatory strategy, operational requirements, and user needs into clear business requirements, functional specifications, user stories, workflows, configuration decisions, and implementation plans
- Evaluate new Veeva releases, functionality, automation opportunities, and industry capabilities and recommend solutions that improve efficiency, compliance, usability, scalability, and regulatory decision-making
- Maintain a strong understanding of the Veeva Vault RIM data model, object relationships, workflows, metadata, security, reporting capabilities, and module interdependencies

*Regulatory Operations, Submissions & Health Authority Support*

- Partner with Regulatory Affairs leads and cross-functional teams to translate global regulatory strategies into clear operational plans, milestones, submission activities, and system requirements
- Support submission planning, content planning, tracking, and execution across development programs and regions, including INDs, CTAs, amendments, annual reports, briefing packages, marketing applications, and other regulatory filings as applicable
- Establish and maintain fit-for-purpose processes for regulatory submissions, registrations, health authority correspondence, questions, commitments, regulatory objectives, and related records
- Ensure health authority interactions, questions, responses, decisions, commitments, and key regulatory milestones are accurately captured, linked, maintained, and readily available within the RIM environment
- Partner with Regulatory Operations colleagues and external vendors to support technically compliant, timely, and high-quality submissions and archival activities
- Develop and maintain portfolio-level visibility into submission plans, milestones, dependencies, status, risks, and health authority commitments
- Identify operational risks, process gaps, and system constraints that may affect regulatory deliverables and collaborate with stakeholders to develop practical mitigation plans
- Support regulatory inspection, audit, and due diligence readiness by ensuring regulatory records and supporting documentation are complete, accurate, traceable, and accessible

*System Configuration, Administration & Lifecycle Management*

- Lead or perform business configuration of Veeva Vault RIM, including users, roles, permissions, metadata, document types, object configurations, workflows, lifecycles, picklists, notifications, reports, and dashboards
- Establish and maintain role-based access, security, and segregation-of-duties controls in partnership with Information Technology, Quality, and functional owners
- Manage the intake, assessment, prioritization, documentation, testing, implementation, and communication of system changes, enhancements, and defect resolutions
- Lead business readiness for Veeva releases and system upgrades, including impact assessments, release planning, regression testing, user acceptance testing, communications, training, and post-implementation support
- Coordinate with technical teams and vendors on integrations, data exchanges, migration activities, system performance, issue resolution, and ongoing platform support
- Maintain system inventories, configuration documentation, traceability records, decision logs, issue logs, enhancement backlogs, and release documentation
- Apply structured change management practices to support successful implementation and sustained adoption of new system capabilities and processes

*Regulatory Data Governance, Quality & Reporting*

- Establish and maintain regulatory data standards, naming conventions, controlled vocabularies, metadata definitions, stewardship responsibilities, and business rules across the RIM environment
- Drive the completeness, consistency, accuracy, timeliness, and traceability of regulatory data and documents across products, applications, registrations, submissions, health authority interactions, objectives, and commitments
- Define and monitor data quality controls, exception reports, reconciliations, and remediation activities to identify and address data integrity risks
- Partner with Regulatory Affairs, CMC, Quality, Clinical, Pharmacovigilance, Enterprise Data, and Information Technology stakeholders to align regulatory information across systems and processes
- Develop, maintain, and continuously improve dashboards, reports, and analytics that provide visibility into submission status, health authority communications, commitments, system adoption, data quality, compliance, cycle times, and operational performance
- Translate RIM data into clear insights, trends, risks, and recommendations that support regulatory planning, prioritization, leadership decisions, and continuous improvement
- Maintain awareness of evolving regulatory data standards and requirements, including IDMP, xEVMPD, structured data, and other global regulatory information initiatives, and assess implications for Dyne’s processes and systems

*Compliance, Validation & Inspection Readiness*

- Ensure Veeva Vault RIM processes, configurations, documentation, and controls comply with applicable GxP requirements, regulatory expectations, company policies, data integrity principles, and validated-system procedures
- Partner with Quality and Information Technology to define and execute a risk-based computer system validation and change-control approach for new capabilities, configurations, integrations, upgrades, and enhancements
- Lead or support validation deliverables, including requirements, risk assessments, test plans, test scripts, traceability, deviations, summary reports, and approval documentation
- Maintain oversight of audit trails, periodic reviews, access reviews, system issues, deviations, corrective and preventive actions, and other compliance-related activities
- Serve as the Regulatory Operations system representative during audits, inspections, due diligence activities, and internal compliance reviews
- Proactively identify compliance and inspection-readiness risks and lead remediation plans in partnership with appropriate stakeholders
- Ensure system and process documentation remains current, approved, controlled, and aligned with actual business practices

*Process Excellence, Documentation & User Enablement*

- Lead the design, harmonization, documentation, and continuous improvement of regulatory operations processes across programs, functions, and regions
- Develop and maintain policies, standard operating procedures, work instructions, process maps, job aids, templates, governance documents, and system administration guides
- Apply a user-centered and risk-based approach to simplify workflows, reduce manual effort, improve cycle times, increase data quality, and strengthen operational consistency
- Develop and execute role-based training, onboarding, refresher training, office hours, and communication plans that build user capability and drive consistent adoption
- Establish a sustainable support model for user questions, access requests, issue triage, escalation, resolution, and knowledge management
- Gather and analyze user feedback, system usage, support trends, and performance data to identify opportunities to improve the user experience and business outcomes
- Promote effective use of Veeva Vault RIM and reinforce accountability for regulatory data ownership, process adherence, and documentation quality

*Cross-Functional Leadership & Vendor Management*

- Serve as a trusted partner to Regulatory Affairs, Regulatory Operations, CMC, Quality, Clinical Development, Clinical Operations, Pharmacovigilance, Medical Writing, Information Technology, Program Management, and other stakeholders
- Lead cross-functional workstreams and projects involving regulatory systems, data, processes, integrations, submissions, and operational readiness
- Facilitate requirements workshops, design discussions, governance forums, status reviews, decision-making sessions, and issue-resolution meetings
- Communicate system strategy, priorities, progress, risks, dependencies, tradeoffs, and recommendations clearly to functional leaders, project teams, and senior stakeholders
- Manage vendor and consultant activities, including scope, timelines, deliverables, quality, issue resolution, knowledge transfer, and performance oversight
- Influence outcomes without direct authority and build alignment across technical and nontechnical stakeholders with differing priorities
- Provide guidance, coaching, and subject matter expertise to system administrators, contractors, regulatory colleagues, and end users
- Model Dyne’s values and foster a culture of accountability, collaboration, integrity, quality, urgency, and continuous improvement

**Education and Skills Requirements:**

- Bachelor’s degree in life sciences, information systems, computer science, regulatory affairs, or a related discipline required; advanced degree preferred
- 8+ years of relevant experience in Regulatory Operations, Regulatory Information Management, regulatory systems, regulatory data management, or a related discipline within the pharmaceutical or biotechnology industry
- 5+ years of direct, hands-on experience with Veeva Vault RIM in a business owner, functional lead, product owner, system administrator, business analyst, or comparable role
- Deep working knowledge of Veeva Vault RIM capabilities, including Registrations, Submissions, Submissions Archive, Publishing, Health Authority Interactions, Regulatory Objectives, commitments, reporting, workflows, metadata, lifecycles, user access, and object security
- Demonstrated experience translating regulatory and business requirements into scalable system configurations, workflows, data standards, reports, and operational solutions
- Strong understanding of global regulatory operations, drug development processes, regulatory submission pathways, regulatory content management, registration management, health authority interactions, and product lifecycle activities
- Experience supporting global regulatory submissions and associated planning, tracking, document management, publishing, archival, and compliance activities
- Demonstrated knowledge of GxP requirements, computer system validation, 21 CFR Part 11, data integrity principles, audit trails, electronic records, change control, and inspection-readiness expectations
- Experience leading Veeva releases, system enhancements, user acceptance testing, validation activities, data migration, system implementation, or integration initiatives
- Experience establishing or improving regulatory data governance, metadata standards, controlled vocabularies, data-quality controls, stewardship models, and reporting practices
- Familiarity with regulatory data standards and initiatives such as IDMP, xEVMPD, structured content planning, and structured regulatory data preferred
- Experience developing dashboards, metrics, reports, and operational insights using Veeva reporting capabilities, Microsoft Excel, Power BI, Tableau, or similar tools preferred
- Demonstrated ability to develop clear policies, standard operating procedures, work instructions, process maps, business requirements, functional specifications, test scripts, training materials, and system documentation
- Strong project and program management skills, with the ability to plan and lead complex cross-functional initiatives, manage dependencies, identify risks, resolve issues, and deliver high-quality outcomes against firm timelines
- Proven ability to lead through influence, build alignment, and collaborate effectively across Regulatory Affairs, Quality, Information Technology, Clinical, CMC, Pharmacovigilance, vendors, and other functional partners
- Strong analytical, critical-thinking, and problem-solving skills, with the ability to evaluate complex processes and data and translate findings into practical recommendations
- Excellent written, verbal, facilitation, and presentation skills, with the ability to communicate technical and regulatory concepts clearly to diverse audiences
- Strong attention to detail and demonstrated commitment to data integrity, compliance, documentation quality, operational excellence, and inspection readiness
- Ability to balance strategic planning with hands-on execution and operate with independence, sound judgment, accountability, urgency, and flexibility in a growing biotechnology company
- Demonstrated ability to manage multiple priorities and adapt effectively in a fast-paced, matrixed environment with evolving business and regulatory needs
- Veeva Vault Administrator certification or other relevant Veeva certification strongly preferred
- Experience in rare disease, neuromuscular disease, genetic medicine, oligonucleotide therapeutics, or a clinical-stage biotechnology environment preferred
- Experience managing vendors, consultants, contractors, or external service providers preferred
- Ability to travel as needed for internal meetings, vendor engagements, training, audits, or other business activities

\#LI-Onsite

MA Pay Range

$160,000 - $195,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Nationwide

AbbVie

Director, Safety Data Sciences (people manager)

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

Purpose: This position partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally.

Responsibilities:

- Responsible for oversight of surveillance and regulatory activities and deliverables in your designated Therapeutic Area (TA).

- Leads a team of Safety Data Sciences in their role on the Product Safety Team (PST) within a given TA; contributes to the benefit risk evaluation and to safety risk management.

- Provide oversight and actively manages full time employee (safety data scientists) and contract support personnel.

- Key collaborator with Therapeutic Area Heads, safety and clinical physicians and Data and Statistical Sciences to develop strategies for routine and ad hoc safety data analyses.

- Independently authors, strategizes and reviews global aggregate safety reports in accordance with regulatory requirements and standard operating procedures

- Utilizes medical judgment to determine the impact of the safety issue on the product’s benefit-risk profile.

- Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plans.

- Assure deliverable alignment to current company standards and global regulations for products/compounds assigned to direct reports.

- Leads safety-related activities/initiatives internal to PPS and with external partners.

- Independently prepares summaries of key safety data for PST, ADT, senior management, Advisory and other similar meetings.

- Trains new safety scientists and mentors established colleagues.

Qualifications

- Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing);
- Bachelors + 7 years clinical/pharma or safety work experience

- Masters or doctorate + 5 years clinical/pharma or safety work experience (e.g. MPH, PharmD, or Masters in a Health Science)

- Knowledge of the drug development process which includes conducting clinical trials, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support.

- Demonstrates ability to connect regulatory obligations and safety science to support safety decision making.

- Understanding of tools, standards and approaches used to efficiently evaluate drug safety.

- Experience in working directly with and influencing senior management including functional heads

- Identifies strengths and weaknesses of team members to further develop their skills through training, mentoring and learning opportunities.

- Optimizes use of team resources and ensures quality and timeliness in team contributions.

- Prior experience with people management desired.

- Identifies new partnerships throughout Abbvie to increase efficiencies

- Initiates strategic plans for deliverables and leads process improvements

- Effective oral and written communication skills with the ability to manage multiple projects simultaneously

- Microsoft WORD and EXCEL skills and Basic Project Management skills

- Able to work independently seeking guidance from manager and PST leads and TA physicians as needed. Able to problem solve and anticipate problems.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Senior Medical Director, Integrated Medical Quality and Device Safety

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

**Position Summary**

Under the direction of the Head of Quality Risk Assessment and Combination Products within Integrated Medical Quality and Device Safety, Global Patient Safety, the Senior Medical Director, serves as a trusted strategic partner, providing medical quality and device safety expertise to cross-enterprise stakeholders. The scope of responsibility spans the entire AbbVie portfolio, with consultation and accountability that may include product complaints, surveillance, quality risk management and device risk management. The Senior Medical Director is a recognized medical and scientific expert who will work closely with Global Patient Safety (GPS) Therapeutic Area stakeholders to support pipeline enablement and strategic development activities for priority pipeline assets, with responsibility for leading the assessment and management of medical device safety signals, product quality issues, and emerging risks, while providing strategic guidance on benefit-risk evaluations and risk mitigation activities. The role drives proactive identification, interpretation, communication, and mitigation of safety concerns while ensuring alignment with global regulatory requirements and AbbVie's patient safety objectives.

**Key Responsibilities**

Signal Detection and Risk Assessment

- Perform medical assessment of product complaints, adverse events, and product quality issues to determine potential patient impact, reportability, and need for escalation.
- Lead evaluation of safety signals, adverse event trends, and emerging risks from post-market surveillance, literature, clinical studies, and other data sources.
- Contribute to and review Post-Market Surveillance System (PMSS) and Post-Market Clinical Follow-Up (PMCF) activities, ensuring integration of safety data into ongoing benefit-risk assessments.

Medical Quality and Device Safety & Risk Management

- Provide medical expertise for Quality Risk Management (QRM) activities, including benefit-risk evaluations, risk mitigation plans, and cross-functional risk reviews.
- Serve as a medical safety expert accountable for Health Hazard Assessments (HHA) for quality and device-related issues.
- Provide medical input and oversight for Device Risk Management activities throughout the product lifecycle, ensuring risks are appropriately identified, evaluated, monitored and controlled.
- Author, review, and contribute to regulatory submissions, health authority responses, deficiency responses, and other regulatory communications related to device safety, product quality, and risk management.
- Support internal and external inspections, audits, and health authority interactions by serving as a subject matter expert for medical device safety, vigilance, and risk management activities.

Cross-Functional Partnership

- Support process improvement initiatives, procedural development, and implementation of best practices to enhance device safety, surveillance, and quality-related processes.

.

Qualifications

**Required Qualifications**

- MD, DO, or equivalent medical degree with specialty residency and minimum 2 years of patient management experience required.
- Minimum of 3 to 5 years of experience in drug safety, medical device safety, clinical development, pharmacovigilance, regulatory science, or related functions.
- Strong understanding of global medical device regulations, including FDA, EU MDR, and other international requirements.
- Experience evaluating complex safety signals and contributing to cross-functional risk assessments.
- Excellent written, verbal, and presentation communication skills.

**Preferred Qualifications**

- Experience with combination products and connected/digital medical devices.
- Experience supporting regulatory inspections and health authority interactions.
- Advanced understanding of risk management, quality systems, and product lifecycle management

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Other Non-US

Immunocore

Senior Director, Global Pharmacovigilance (Safety Physician)

Vacancy Name

Senior Director, Global Pharmacovigilance (Safety Physician)

Vacancy No

VN756

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA, Remote, US

Department

Regulatory Affairs

Key Responsibilities

The Senior Director, Global Pharmacovigilance (Safety Physician) is a senior medical leader accountable for the global medical safety strategy, benefit–risk assessment, and risk management of Immunocore’s development and marketed products. The role holder is a board-certified physician and recognized subject matter expert in pharmacovigilance, with deep experience in biologic product safety, signal detection, epidemiology, and regulatory benefit–risk decision making (e.g., FDA, EMA and other Health Authorities), providing strategic and operational leadership across all phases of the product lifecycle from early development through post marketing.

Key aspects of the role include leading proactive, data driven benefit–risk assessment and advanced signal detection using clinical trial, post marketing, and real world data; shaping and executing global Pharmacovigilance Plans and Risk Management Plans, including the design and interpretation of post authorization safety and active surveillance studies; directing and developing a team of pharmacovigilance physicians and safety professionals by setting strategy, building capabilities, and embedding best practices aligned with Immunocore’s Senior Director career framework; and serving as the senior medical safety authority for assigned products, representing Immunocore in high level interactions with global Health Authorities and external partners.

KEY RESPONSIBILITIES

• Develop and implement global pharmacovigilance strategies for assigned products, aligned with clinical, regulatory, and commercial objectives.

• Lead ongoing benefit–risk assessments using data from clinical trials, post marketing surveillance, real world data sources, and epidemiologic/active safety studies.

• Oversee systematic signal detection and evaluation from Individual Case Safety Reports, aggregate/periodic reports, literature, and other data sources.

• Direct the design, conduct, and interpretation of active safety surveillance and pharmacoepidemiology studies to characterise and quantify product risks.

• Lead multidisciplinary Safety Management/Safety Review Teams to drive signal evaluation, surveillance strategies, and risk mitigation recommendations.

• Be accountable for the medical and scientific quality of aggregate safety reports, Pharmacovigilance Plans/RMPs, Investigator’s Brochures, and safety sections of regulatory submissions.

• Provide senior medical safety leadership for global regulatory submissions and labelling negotiations, and respond to Health Authority queries on product safety, benefit–risk, and risk management.

• Provide senior level oversight of medical review of ICSRs, ensuring accurate assessment of causality, seriousness, expectedness, and clinical relevance.

• Guide internal teams and external vendors/CROs on best practices for safety data collection, coding (e.g., MedDRA), evaluation, and use of safety databases and analytics tools.

• Serve as the senior safety representative on cross functional clinical and project teams, ensuring integrated safety input into study design, protocols, analyses, and portfolio decisions.

• Champion cross functional collaboration and engagement with external stakeholders to shape Immunocore’s safety strategy and external scientific profile.

• Lead continuous improvement of PV processes, SOPs, and tools, and maintain current knowledge of evolving pharmacovigilance and biologic safety guidance.

SUPERVISORY RESPONSIBILITY

This position will not have line manager responsibilities, but provides safety leadership to cross functional teams

EXPERIENCE & KNOWLEDGE

Essential

• Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.

• Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.

• Knowledge of clinical development process

• Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality.

• Demonstrated track record in Authoring or overseeing aggregate safety reports (DSURs, PSURs/PBRERs, PADERs) and contributing to major regulatory submissions (e.g., BLA, MAA) and subsequent labelling updates.

Desirable

• Advanced degree in epidemiology, pharmacology, or biomedical sciences (PhD/MPH)

• Knowledge of drug approval process in major countries

• Experience with different commercially available safety databases.

• Board certification in a relevant specialty

• Experience with global product launches and implementation/assessment of complex risk minimisation measures.

• Evidence of scientific contributions to the field (e.g., peer reviewed publications, invited presentations, guideline development, or recognised subject matter expertise in biologic safety).

EDUCATION & QUALIFICATIONS

• M.D./D.O. degree with at least five years of pharmacovigilance experience, and at least two years of clinical experience or relevant experience to understand clinical drug development

• At least five years of practical clinical experience post licensure

US Salary Range

$187,500-$312,000

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Maryland

Director, Global Pharmacovigilance / Safety Operations

Vacancy Name

Director, Global Pharmacovigilance / Safety Operations

Vacancy No

VN757

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor PA, Oxford, UK, Remote US

Department

Regulatory Affairs

Key Responsibilities

The Director, Safety Operations is a senior pharmacovigilance operations leader accountable for the end-to-end execution, quality, and continuous improvement of global safety operations for Immunocore’s development and marketed products. The role holder is an experienced pharmacovigilance professional with deep expertise in case management, safety systems, PV compliance, and vendor oversight.

The role leads global case management, regulatory reporting, and safety operational processes across clinical and postmarketing settings, ensuring a robust, inspection ready PV system that meets GVP and other global regulatory requirements (e.g., MHRA, EMA, FDA, ICH, CIOMS). The Director oversees safety databases and related tools (including configuration, validation, and lifecycle management in partnership with IT and Safety Systems), manages external vendors/CROs, and builds a high performing Global Safety Operations team with direct line management responsibilities. The role also partners closely with Safety Physicians and cross functional stakeholders to ensure high quality safety data supports signal detection, aggregate reporting, and benefit–risk assessment throughout the product lifecycle, providing both strategic direction and hands-on operational leadership.

KEY RESPONSIBILITIES

• Lead and continuously improve global safety operations processes, including case intake, processing, and submissions, ensuring alignment with global PV regulations and company policies.

• Oversee timely and compliant case processing and regulatory reporting of Individual Case Safety Reports (ICSRs) from all sources.

• Ensure robust operational oversight of internal and external safety case management, including performance monitoring and quality metrics.

• Provide strategic leadership for the selection, configuration, validation, and life-cycle management of safety systems and tools, in partnership with IT and Safety Systems teams.

• Lead the design, implementation, and maintenance of standard operating procedures (SOPs), work instructions, and training for safety operations.

• Ensure inspection readiness and support internal audits, Health Authority inspections, and partner audits related to PV operations, coordinating responses and remediation plans.

• Collaborate with Safety Physicians and cross-functional teams to ensure high-quality data for signal detection, aggregate safety reporting, benefit–risk assessments, and Risk Management Plans (RMPs).

• Provide senior operational input into Safety Management Teams and cross-functional project teams, managing operational feasibility, timelines, and compliance risks.

• Lead operational aspects of safety data exchange agreements (SDEAs) with partners and licensees and oversee literature surveillance workflows.

• Recruit, lead, and develop a Global Safety Operations team, manage budgets and resources, and act as the primary point of contact for safety operations with internal stakeholders.

SUPERVISORY RESPONSIBILITY

This position has direct line management responsibilities for a team of global safety operations professionals with matrix oversight of additional staff or vendor teams performing PV operational activities.

COMPETENCIES

• Strong expertise in pharmacovigilance operations, including case processing, regulatory reporting, PV systems, and vendor oversight in a GVP regulated environment.

• Demonstrated leadership and people management skills, with experience building and developing teams.

• Strong analytical, organizational, and project management skills, with the ability to manage multiple priorities and deliver high quality outcomes to tight timelines.

• Excellent written and verbal communication skills, able to convey complex operational and regulatory concepts clearly to both technical and non-technical audiences.

• Proven ability to collaborate effectively across functions and regions, building strong relationships and influencing without direct authority.

• High level of integrity, discretion, and commitment to patient safety, compliance, and ethical conduct.

EXPERIENCE & KNOWLEDGE

Essential

• Extensive experience (5+ years) in pharmacovigilance operations, with significant leadership in global ICSR management and regulatory reporting.

• In-depth knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA) and proven ability to implement them operationally.

• Strong experience with safety databases and PV systems, including configuration, validation, and maintenance.

• Demonstrated ability to lead, develop, and manage a team of PV professionals and oversee PV vendors/CROs.

• Proven track record in preparing for and supporting Health Authority inspections and audits, alongside strong project management skills.

Desirable

• Advanced degree in a relevant scientific or health-related field.

• Experience with safety data exchange agreements (SDEAs) and literature surveillance.

• Demonstrated ability to drive continuous improvement, process optimization, and automation in PV operations.

• Familiarity with operational support for Risk Management Plans (RMPs) and aggregate safety reports.

• Demonstrated understanding of clinical development processes.

• Experience with global product launches and implementation/assessment of complex risk minimisation measures.

• Evidence of scientific contributions to the field (e.g., peer reviewed publications, invited presentations, guideline development, or recognised subject matter expertise in biologic safety).

EDUCATION & QUALIFICATIONS

• Bachelor's degree or equivalent in a life science, pharmacy, nursing, or a related health field.

• Relevant certifications in pharmacovigilance or drug safety are highly desirable.

US Salary Range

157,500-$262,500

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Laboratory Vendor Specialist, Clinical Operations

Vacancy Name

Laboratory Vendor Specialist, Clinical Operations

Vacancy No

VN868

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA

Department

Clinical Operations

Key Responsibilities

The Laboratory Vendor Specialist is responsible for supporting the oversight and management of Immunocore’s relationships with multiple laboratory vendors. This is an office-based position with flexibility.

The Laboratory Vendor Specialist will support the day-to-day management of samples and lab vendors assigned to them. Works with Clinical Operations (Clin Ops), Translational Medicine, Data Management, and appropriate departments to support centralized clinical trials sample management, as well as specific project/study or a business/therapeutic area needs. Managing/supporting study teams with lab set up; including vendor selection, early protocol input and creating documents.

The Lab Vendor Specialist will be expected to develop a strong knowledge of external central and third-party testing lab(s) processes and ensure lab vendors contracted, IMC Clinical Study Teams, and CRO staff reporting to them have the proper support. The Lab Vendor Manager will ensure proper vendor setup, governance, and timeline development for key trial deliverables involving the lab vendors and the Lab Vendor Specialist will support these efforts. The lab vendor specialist will assist with managing/supporting study teams with lab set up, including vendor selection, early protocol input, and creating protocol specific documents.

This position requires both hands-on study and lab vendor management support. Immunocore’s ideal candidate possesses knowledge of GxP, FDA regulations, vendor-sponsor best practices, strong technical skills, can support infrastructure assessment and improvement, and is a self-starter. This lab vendor specialist has a crucial role that will assist in ensuring that all vendors meet Immunocore’s standards for quality, efficiency, and compliance in conducting Phase 1, 2, and 3 clinical trials.

Key Responsibilities:

• Assist with the development and approval of controlled documents related to clinical study.

• Support Vendor Selection and Onboarding

• Assist in the evaluation, selection, and onboarding of laboratory vendors.

• Quality Metrics:

• Assist in the development of KPI’s for lab vendors, supporting, monitoring, and evaluation of the lab vendor performance.

• Lab vendor invoice review

• Assist in the review of lab vendor invoices, ensuring they align with contracted terms.

• Compliance:

• Assist in raising lab vendor quality compliance issues with Immunocore’s internal QA team.

• Assist in identifying, developing, and implementing risk mitigation strategies associated with lab vendors as needed across IMC programs.

• Support and assist in the preparation of internal and external clinical operations teams for laboratory vendor audits.

• Reporting:

• Assist in downloading and disbursing lab vendor reports provided by laboratory vendor.

• Assist in compiling reports on lab vendor performance, cost-effectiveness, and compliance to share with the internal study team and stakeholders.

• Continuous Improvement:

• Identify opportunities for process improvements within Immunocore current processes.

• Assist is identifying cost saving initiatives to implement with laboratory vendors.

• Review lab vendor audit reports with clinical management.

• Protocol Lifecycle support

• Preparation and review of clinical study documents such as but not limited to the laboratory specification documents, sample management plans, and laboratory manuals.

• Support study specific trainings

• Track external sample shipments from site collection through third-party vendor receipt, with close monitoring on potentially delayed or missing samples to ensure accurate data delivery to meet study timelines.

• Works collaboratively with key stakeholders (e.g., Clinical study teams, Clinical Study Sites, and external lab vendors) to ensure proper alignment and study level execution of scientific and operational strategies of the lab vendors assigned.

• Transcribe internal and external lab vendor/sample management meetings on specified cadence; contributes as a sample management representative at interdepartmental meetings, study conduct/governance meetings and is responsible for filing these meeting minutes to IMC’s internal TMF.

• Manage lab vendor access reports and ensure laboratory vendors are kept up to date on protocol contacts.

Other Duties:

• Direct and train on Clinical Standard Operating Procedures and to ensure compliance with regulatory organizations.

• Organize pre- and post-study document reviews and takes corrective action.

• Assist leadership in continuous improvement of good clinical practices.

• Drives timely completion of assigned goals and organizational changes within the organization.

• Leads by example to create a positive work environment, encouraging mutual respect, accountability, smart risks, and innovation.

• Offers help, support, and knowledge to drive for success across the organization and company.

• Regularly interact with senior management or executive levels on matters concerning several functional areas

Education, Experience and Knowledge:

Essential Qualifications:

• 3 + years, of laboratory operations, pharmaceutical or biotech-related/experience required.

• Experience working in a matrix environment, assisting leadership across multiple studies.

• Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint) and ability to develop proficiency in relevant sponsor systems and programs.

• Strong communications and organizational skills

• GXP compliant

Non-Essential Qualifications:

Prior experience with the following would be advantageous.

• Risk Management

• Sample Management

• Process Improvements

US Salary Range

$101,000- $115,000

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

Vacancy Name

Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

Vacancy No

VN514

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA

Department

Clinical Operations

Key Responsibilities

This is an onsite position and can be located at either our Gaithersburg, MD or Conshohocken, PA sites.

The Clinical Compliance/Inspection Readiness, Manager is responsible for the management and execution of activities associated with inspection preparedness, inspection support, clinical procedural development and maintenance, clinical training programs, and assessment and investigation of clinical quality compliance issues. This onsite position can be located at either our Gaithersburg, MD or Conshohocken, PA sites.

KEY RESPONSIBILITIES

• Lead the development and delivery of GCP and Inspection Readiness training for the Clinical o organization

• Lead the development and implementation of processes and tools to support teams and functions in being inspection ready

• Provide ongoing inspection readiness support and expertise to study teams, including risk mitigation and monitoring

• Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections, including support of ongoing storyboarding

• Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities

• Coordinate follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)

• Generate, analyze and communicate inspection readiness metrics

• Drive continuous improvement into inspection readiness and inspection conduct support

• Lead the development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates in compliance with global regulatory standards

• Lead the strategy execution for role-based curriculum and GCP training within the Clinical organization

• Collaborate with QA with the preparation/collection of all training documents in preparation for internal training file audit (e.g., completed SOP matrices, CVs, JDs etc.)

• Assist with oversight and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments in collaboration with Quality Assurance

• Assist with management and oversight of the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and

closure

• Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.

• Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)

• Track status of open Quality Issues and CAPAs and coordinate with Clinical stakeholders to ensure timely and adequate closure, as appropriate

• Generate, report, and respond accordingly to compliance/inspection readiness KPIs

OTHER DUTIES

• Support and prepare internal and external clinical operations teams for audits

• Provide training on Clinical Standard Operating Procedures and Work Instructions to ensure compliance with regulatory organizations.

• Support and manage in collaboration with Quality Assurance the clinical quality database observations

• Identify opportunities and provide leadership in continuous improvement of good clinical practices.

• Establish and assure adherence to budgets, schedules, work plans, and performance requirements, relative to inspection readiness support and clinical compliance activities.

• Regularly communicate with senior management or executive levels on matters regarding several functional areas

Experience & knowledge

Essential

• At least 8 years relevant experience in a biotechnology/pharmaceutical industry and/or contract research organization (CRO) with experience in compliance, quality, training or related clinical operations function.

• Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP.

• Ensure an enthusiastic and open attitude towards continuous professional development

• Experience with the following skill set:

o Performing PAI and Inspection readiness assessments

o Making high level presentations, both orally and in writing using organizational skills to

complement this

o Delivering open and honest constructive (positive and/or negative) feedback pertaining to

work in hand

oTaking responsibility and ownership for entrusted tasks; seeing tasks through to completion

and dealing with the consequences of failure or success.

o Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities.

Handling disjointed tasks effectively. in a highly collaborative, multi-disciplinary team setting.

o Being able to work productively with others to achieve tasks while showing consideration

for the needs and feelings of others.

o Accomplishing goals under project timelines.

Desirable

Prior experience with the following would be an advantage

• Clinical auditing and relevant clinical operations functions

• Compliance and training

Education & qualifications

• BA / BS. or higher in science related field (biological science, medical, pharmacy or other health related discipline)

• 8+ years’ experience in related area with some experience in QA/Audit setting preferred

• Clinical Operations and/or Inspection Readiness experience preferred

• Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)

Some international and local travel maybe required. Approximately up to 20 % travel.

$107,250-$178,750

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

United States Pharmacopeia

Senior Manager, Cloud Operations

**Description**

**Who is USP?**

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

**Brief Job Overview**

The Cloud Operations Senior Manager is responsible for the strategy, reliability, performance, and continuous optimization of AWS cloud services, data platforms, ETL workloads, and Acquia/Drupal environments that support both enterprise and customer-facing applications. This role ensures cloud and platform solutions are architected appropriately to meet business needs while maintaining security, scalability, resilience, compliance, and cost efficiency. The position leads operational delivery and service management practices, driving platform stability, automation, monitoring, incident response, and continuous improvement across critical technology services. The manager provides technical leadership and architectural guidance to cloud operations teams, ensuring alignment with enterprise standards and long-term technology strategy. Success in this role is measured by the ability to translate cloud operations and architecture into reliable, high-value business outcomes through strong stakeholder partnerships and operational excellence.

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

**The Senior Manager, Cloud Operation has the following responsibilities:**

- **Lead AWS Cloud Operations** – Own the availability, performance, security, scalability, resilience, capacity management, and operational health of AWS cloud services and platforms.
- **Provide Cloud Architecture Leadership** – Guide AWS platform and solution architecture decisions to ensure alignment with business requirements, enterprise standards, security policies, supportability, and cost-effectiveness.
- **Manage Data Platforms & ETL Reliability** – Oversee AWS data platforms, ETL/ELT pipelines, and analytics workloads to ensure reliable, secure, and high-performing data processing services.
- **Oversee Acquia & Drupal Platform Operations** – Ensure stability, performance, security, and operational readiness of Acquia-hosted Drupal applications supporting enterprise and customer-facing services.
- **Drive Reliability, Monitoring & Incident Management** – Establish observability, monitoring, alerting, and incident response practices while leading root-cause analysis and continuous service improvement initiatives.
- **Advance Automation & DevOps Practices** – Champion Infrastructure-as-Code, CI/CD, automation, and operational efficiency initiatives to improve deployment reliability and reduce manual effort.
- **Ensure Security, Governance & Compliance** – Partner with cybersecurity and architecture teams to enforce cloud security controls, governance standards, audit readiness, risk management, and regulatory compliance.
- **Optimize Cloud Financial Management** – Drive AWS cost transparency, governance, forecasting, resource optimization, and financial accountability while balancing performance, reliability, and business value.
- **Lead Service Management & Operational Excellence** – Establish ITIL-aligned service management practices, maintain operational documentation, and continuously improve processes, service maturity, and user experience.
- **Develop High-Performing Teams & Partnerships** – Lead cloud and platform operations teams, foster technical growth and accountability, and build strong partnerships with business stakeholders, architects, developers, vendors, and support organizations to deliver measurable business outcomes.

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

- Bachelor’s degree in Computer Science, Information Technology, Engineering, or related field, or equivalent combination of education and experience.
- 10+ years of AWS cloud experience with 4-5 years in Senior Cloud Engineer / Architect role
- 5+ years of management experience leading technical teams
- AWS Solutions Architect Professional, AWS DevOps Engineer Professional, or equivalent certifications
- **AWS Cloud Operations Expertise** – Deep experience managing AWS production environments, including compute, storage, networking, databases, security, monitoring, capacity planning, resiliency, backup/recovery, and cost optimization.
- **Cloud Architecture & Solution Design** – Ability to evaluate business and technical requirements and recommend scalable, secure, resilient, supportable, and cost-effective AWS architectures aligned with enterprise standards.
- **AWS Data Platforms & ETL Operations** – Strong knowledge of AWS data services, ETL/ELT pipelines, workflow orchestration, data warehouse operations, and data platform reliability, performance, and governance.
- **Cloud Security & Compliance** – Experience implementing AWS security best practices including IAM, encryption, network security, logging, access governance, secure configuration management, and compliance controls.
- **Infrastructure-as-Code & Automation** – Hands-on experience with Terraform, CloudFormation, scripting, and automation technologies to improve consistency, efficiency, and operational scalability.
- **DevOps & CI/CD Practices** – Knowledge of DevOps methodologies, CI/CD pipelines, release automation, source control, and deployment processes that improve software delivery and operational readiness.
- **Monitoring, Observability & Troubleshooting** – Expertise with CloudWatch, including performance analysis, alerting, dashboards, and root-cause investigation.
- **Acquia & Drupal Platform Support** – Experience supporting Acquia Cloud and Drupal-based platforms, including web performance, security patching, release coordination, troubleshooting, caching, and CDN integration.
- **IT Service Management & Operational Excellence** – Strong understanding of ITIL processes including Incident, Problem, Change, Request, and Knowledge Management, with experience using ServiceNow or similar ITSM platforms.
- **Cross-Functional Partnership & Technical Leadership** – Ability to collaborate effectively with architects, developers, data engineers, security teams, vendors, and business stakeholders to deliver reliable, secure, and well-architected cloud service.

**Supervisory Responsibilities**

Yes, the Senior Manager will oversee:

- 3 full time US based AWS Engineers,
- 1 Drupal Developer/Aquia Operations Engineer, and
- 1 AWS Engineer Contractor (located in India)

**Benefits:**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

**Compensation:**

Base Salary Range: **USD $139,453.00 – $198,720.00** annually.

Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

**Job Category** Information Technology

**Job Type** Full-Time

ADMA Biologics

Technician I, Purification

Job Description

**ADMA Biologics** is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a **Technician I, Purification!**

Job Title: Technician I, Purification

Job Description:

**Position Summary**

This position is under direct supervision of the Group Leader. This experienced position is responsible for the manufacture of plasm products through protein separation and other tasks involving Ultrafiltration, Chromatography, and Nanofiltration.

**Night Shift: 7:00 PM - 7:00 AM**

**Essential Functions (ES) and Responsibilities**

- Cleans and sanitizes equipment before and after use.
- Responsible for production operations.
- Makes and verifies connections on flow panels.
- Performs pH and conductivity measurements.
- Performs chemical and buffer additions.
- Operation of Ultrafiltration system.
- Initiates product processes on the Process Automated System (PAS).
- Column chromatography using up to 80cm columns.
- Takes and prepares product samples.
- Orders and maintains raw material inventories.
- Complete batch records.
- Assists Group Leaders in training of other tech positions.

**Job Responsibilities or Job Requirements**

**Competencies**

Ability to follow the cGMP’s and procedures with great attention to detail

**Experience Requirements**

**Education Requirements:** Bachelor’s degree or equivalent experience.

**Experience Requirements:** GMP experience required.

**Preferred Experience**

**Compliance Requirements (ES)**

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

**In addition to competitive compensation, we offer a comprehensive benefits package including**:

- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit [www.dhs.gov/E-Verify](<https://www.dhs.gov/E-Verify>).

ADMA Biologics is an Equal Opportunity Employer.

Florida

Frederick National Laboratory for Cancer Research

Business Process Specialist IV

**Business Process Specialist IV**

Job ID: req4714

Employee Type: exempt full-time

Division: Facilities, Maintenance & Engineering

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Facilities Maintenance and Engineering (FME) Directorate is responsible for laboratory space, administrative space, infrastructure, campus landscape, planning, and design, and construction management at Frederick National Laboratory for Cancer Research.

The Business Process Specialist IV serves as a senior process improvement and operational excellence leader within the Facilities Maintenance & Engineering Department. This position is responsible for planning, leading, and implementing enterprise-level process improvement initiatives that enhance quality, efficiency, reliability, compliance, and customer service across facilities operations, engineering services, maintenance programs, and capital project activities.

**KEY ROLES/RESPONSIBILITES**

- Lead the planning, execution, and implementation of process improvement initiatives across facilities maintenance, engineering operations, asset management, and support services.
- Analyze and evaluate existing workflows, operational procedures, and business processes to identify inefficiencies, quality concerns, bottlenecks, and improvement opportunities.
- Develop sustainable solutions that increase efficiency, reduce waste, improve reliability, enhance quality, and strengthen compliance.
- Facilitate process redesign efforts that support organizational goals and operational excellence objectives.
- Collaborate with leadership to establish and maintain process control frameworks that promote consistency, accountability, and quality outcomes.
- Analyze process variation and identify opportunities to strengthen process controls and reduce operational risk.
- Ensure process improvement efforts align with applicable regulatory, accreditation, safety, and organizational requirements.
- Develop and maintain process maps, workflow diagrams, value stream maps, standard operating procedures, and process documentation.
- Collect, validate, analyze, and interpret operational and performance data to support decision-making and continuous improvement efforts.
- Lead root cause investigations and problem-solving initiatives involving operational, quality, compliance, and performance-related issues.
- Develop recommendations and action plans to address identified issues and improve long-term process stability.
- Track implementation of corrective actions and assess effectiveness of process improvements.
- Organize, lead, and facilitate multidisciplinary project teams focused on process improvement, quality enhancement, and operational transformation initiatives.
- Serve as a strategic advisor to department leadership regarding process improvement opportunities and operational effectiveness.
- Collaborate with engineering, maintenance, quality assurance, facilities operations, environmental health and safety, project management, finance, procurement, and other stakeholders.
- Coordinate project activities, monitor progress, and communicate outcomes to leadership and stakeholders.
- Promote a culture of continuous improvement and operational excellence throughout the directorate.

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in Business Administration, Industrial Engineering, Operations Management, Engineering, Quality Management, Facilities Management, Public Administration, or a related field. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirements, a minimum of eight (8) years of related experience in process improvement, operational excellence, quality management, business process analysis, engineering operations, facilities management, or a related field is required.
- Experience leading complex process improvement projects and facilitating cross-functional teams.
- Demonstrated experience applying Lean, Six Sigma, process re-engineering, or similar methodologies to improve organizational performance.
- Advanced knowledge of process improvement, business process management, quality assurance, and process control methodologies.
- Strong understanding of operational performance measurement, KPI development, statistical analysis, and continuous improvement principles.
- Experience conducting root cause analysis, process mapping, workflow analysis, and organizational assessments.
- Knowledge of facilities maintenance operations, engineering services, asset management practices, or related operational environments.
- Ability to analyze complex business and operational challenges and develop practical, data-driven solutions.
- Strong facilitation, project management, leadership, and stakeholder engagement skills.
- Excellent written, verbal, and presentation communication skills.
- Ability to influence change and build consensus across diverse stakeholder groups.
- Proficiency with Microsoft Office Suite, process mapping tools, reporting platforms, and data analysis applications.
- Experience in biotechnical facilities, government facilities, utilities, manufacturing, or other highly regulated environments.
- Experience with Computerized Maintenance Management Systems (CMMS), Enterprise Asset Management (EAM) systems, or Integrated Workplace Management Systems (IWMS).
- Knowledge of ISO quality management standards, reliability-centered maintenance principles, accreditation requirements, or regulatory compliance frameworks.
- Ability to obtain and maintain a security clearance.

**PREFERRED QUALIFICATIONS**

**Candidates with these desired skills will be given preferential consideration:**

- Preferred certifications: Certified Facility Manager (CFM), Project Management Professional (PMP), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent.

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

98,200.00 - 144,600.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Nurix Therapeutics

Principal Engineer, Pharmaceutical Development

**Principal Engineer, Pharmaceutical Development Engineering**

*Own the hands-on engineering that turns a promising molecule into a manufacturable drug product — leading process development, scale-up, and CDMO operations for Nurix's late-stage clinical and commercial programs. This is a highly technical, high-autonomy role with direct impact on getting real treatments to patients.*

**Position Description**

**The Opportunity**

- Provide engineering leadership for small-molecule drug product manufacturing process development and optimization to facilitate process transfer to CDMOs and scale-up.
- Lead equipment engineering and operations at drug product CDMOs, including technology transfer, CTM production, process troubleshooting, QBD, DOEs and PAR studies, registration batch production, and process validation.
- Coordinate with CDMOs and Nurix QA, Chemical Development, and Global Supply Chain functions to ensure timely manufacture and release of DP lots.
- Partner with Nurix Chemical Development and Analytical Development & Quality Control to identify critical process parameters of associated equipment and facility, and overall control strategies.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Nurix policies and procedures.
- Provide Person-In-Plant support for drug product manufacturing and ongoing performance monitoring of key facility and operational KPIs across manufacturing sites, including schedule adherence, batch performance, deviation trends, and inspection readiness.
- Support operational execution related to equipment scheduling, manufacturing, and coordination, supporting both clinical and commercial production requirements.
- Write and review CMC sections of regulatory filings, including INDs, IND amendments, and NDAs.
- Ensure all equipment trains at CDMOs are properly qualified, maintained, and operating at optimal performance to support Nurix manufacturing operations.
- Provide technical mentorship and guidance to scientists and engineers.

**What You’ll Bring**

- Ph.D. in chemical engineering or a related field with at least 8 years (M.S. with 12 years, or B.S. with 16 years) of industrial, late-phase, small-molecule drug product development experience.
- Extensive knowledge and experience in GMP oral solid dose form manufacturing (spray drying, tableting, and encapsulation), characterization, process development, equipment evaluation/selection, scale-up, and process validation.
- Extensive third-party drug product CDMO management experience, including tech transfer activities, QBD and DOE studies, clinical supply production, registration batch production, and commercial launch activities.
- Knowledge and understanding of product/packaging interactions, barrier properties, stability, global pharmaceutical packaging regulations, and package testing.
- In-depth knowledge of relevant cGMP, ICH, FDA, and EMA guidelines.
- Proven track record of effective internal and external collaboration.
- Excellent oral/written communication skills, interpersonal skills, and problem-solving abilities.
- Ability to multi-task, manage conflict, and work in a fast-paced environment.
- Ability to travel up to 25% of time.

**Salary Range:**  $195,300 - 222,900

*The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.*

**Location:** Onsite – Brisbane, CA

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

**About Nurix Therapeutics**

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

California

Lead, Value Stream

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The Value Stream Lead (VSL) will represent their area of responsibility for the Specialty Formulation or Packaging Departments. The VSL will ensure efficiency and continuous improvement for their node while ensuring compliance is met in local, federal, and global regulations. The individual contributor will work closely with department management and cross-functional partners to ensure building the strategy for new product introductions and launches, customer on-going commitments and overall functionality of the value stream.

Responsibilities

- Drive next generation Industry 4.0 Factory of the Future (FotF) initiatives for AP16 on applicable nodes by consulting on and driving process automation and dynamic growth models.
- Lead respective node health check meetings to drive optimized scheduling, root cause analysis, downtime mitigation, OEE improvements and sustained OEE performance.
- Lead production floor team member meetings to empower floor personnel with the need to drive sustained line performance and recycle ideas/feedback between health check and team member meetings.
- Build successful strategies for New Product Introductions (NPIs) and launches on existing and/or new packaging lines. Be the conduit for novel ideas and improvements while proactively looking for best and worst case models/scenarios for respective nodes.
- Assist management with cost standard quoting process of existing and new processes and drive continuous improvements to achieve optimized cost standards.
- Consult and be stakeholders of appropriate Change Management and CAPAs driven from improvement projects and RCAs respectively.
- Participate in risk assessments in the areas of human error, EM (extraneous matter), and line clearance failures for respective nodes.
- Consult on mitigation pathways for external issues impacting the performance of respective node (supplier related issues etc.)

Qualifications

- Bachelor's degree in Science, Engineering or Business Administration. Five years experience in a manufacturing facility preferably in packaging.
- Excellent listening, verbal, written communications as well as organizational skills with the ability to prioritize workload and manage conflict.

\#LI-CD3

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Novo Nordisk

Senior Alternative Models Operations Manager

**About the Department**

Novo Nordisk’s Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions that drive patient access to innovative products. We strive to deliver the best possible outcomes for patients with diabetes, obesity, growth hormone deficiencies and rare bleeding disorders through mutual wins for both Novo Nordisk and our Market Access customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide information to healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the people who need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential?

**The Position**

Responsible for managing day-to-day operations of pharmacy programs. This person will be responsible for driving new initiatives related to appropriate patients to ensure these programs provide best-in-class support while keeping on budget and continuously evaluating approach for efficiencies. Develops and reports insightful metrics to relevant groups contributing to pharmacy operations to assess operational performance. This individual will maintain a high-level of collaboration and integration with all field-based teams, Brand Marketing, Training, Commercial Insights and Analytics, Managed Markets, Legal, Compliance, and Finance. This position has high exposure to senior management and requires a highly motivated individual who is able to work cross-functionally & independently in order to accomplish objectives.

**Relationships**

Reports to the Director, Alternative Models Operations. Key internal relationships include brand marketing, market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory. Other internal relationships include Public Affairs, Government Affairs & US Corp Giving & Social Impact. External relationships include relations with patient/caregiver consultants and key opinion leaders (KOLs), professional organizations, customers and patient support service providers and organizations.

**Essential Functions**

- Develop, design, and implement pharmacy capabilities and ongoing management of pharmacy programs
- Support inline and future launch products. This includes supervising vendors related to pharmacy support programs
- Partner with existing patient support program leads, with a focus on operational excellence in support of patient needs
- Develop performance dashboards and interpret data for purposes of assessing market access trends, hub program utilization, and performance against defined KPIs
- Understand relevant competitive environment and understand their pharmacy and access strategies
- Collaborate cross functionally within the commercial organization to design and implement pharmacy programs that support the company’s patient support objectives for inline and launching brands
- Champion integrated approach across teams to provide a best-in-class service offering to internal and external customers
- Builds and maintains trusting, collaborative relationships and alliances with internal and external partners, focused on addressing key business issues, objectives, and processes
- Enhance the customer experience via benchmarking, customer feedback, auditing and active call monitoring
- Ensure strong collaboration with relevant cross-functional stakeholders
- Develop and maintain SOPs and business rules related to US patient support. Maintain program SOPs, exceptions processes, workflows, scripting, training and reports. Manage external partner performance against contractual arrangements, SOPs, KPIs, and budget
- Drive development of company-wide processes and guidelines to support customer-focused objectives
- Responsible for developing communications and engagement strategies for internal audiences and key external customers
- Deliver periodic updates on programs to organization during POAs and other appropriate meetings
- Demonstrate fiscal discipline and accountability to effectively and efficiently manage external partners and vendors’ performance through appropriate metrics. Negotiate and executes contracts / SOWs and budgets for desired services

**Physical Requirements**

10-20% overnight travel required.

**Qualifications**

- Bachelors degree from and accredited institution or equivalent is required. Experience with patient support hubs, pharmacies and/or healthcare institutions preferred
- A minimum of seven (7) years of experience in any of the following areas: patient services operations, pharmaceutical sales, marketing, market insights, market research, contracting, managed markets strategy, or value communication within payer marketing, national account management, consulting, OR a minimum of three (3) years of experience in strategic market access or pharmacy operations in the pharmaceutical industry
- Ability to translate strategies into measurable programs that have high ROI
- Agency/Vendor management experience required
- Ability to lead and collaborate on cross-functional teams required
- Anticipates problems and roadblocks to avoid crisis management
- Must have proven track record of developing accurate short- and long-term business plans, results and follow up
- Must have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes
- Develops accurate short- and long-term plans, forecasting, and business analysis
- Project Management and Quantitative analysis skills
- Intermediate proficiency in Windows, MS Word, PowerPoint and Excel required

The base compensation range for this position is $120,000 to $222,500. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

New Jersey

Senior Technical Manager

**Description**

**Who is USP?**

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

**Brief Job Overview**

The Senior Technical Manager will serve as a technical lead for donor- and program-funded initiatives across supply chain technical assessment and lab-based advanced manufacturing. This role will support execution through route scouting, process development, scale-up, technology transfer support, technical assessment, workstream coordination, and high-quality project deliverables. The position is suited for a technically strong, execution-oriented professional who can translate complex manufacturing, process chemistry, and supply chain questions into practical workplans, laboratory activities, technical assessments, and clear deliverables.

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

The Senior Technical Manager has the following responsibilities:

**Technical Implementation and Lab-Based Project Execution**

- Lead technical implementation workstreams for supply chain technical assessment and lab-based advanced manufacturing projects.
- Plan and coordinate laboratory-based activities, including route assessment, process development, scale-up, troubleshooting, purification, characterization, and technology evaluation.
- Apply process chemistry, API development, CMC, and advanced manufacturing expertise to practical project challenges.
- Develop and review technical plans, protocols, reports, briefing materials, and project documentation to support high-quality execution and decision-making.

**Supply Chain Technical Assistance and Advisory Support**

- Conduct structured technical, market, literature, and database reviews to assess API and KSM manufacturing routes, suppliers, technologies, cost drivers, and supply vulnerabilities.
- Evaluate manufacturing processes, sourcing structures, technical feasibility, supply-market dynamics, and risk factors to identify practical mitigation options.
- Contribute to technoeconomic analyses, due diligence, supplier and route evaluations, and risk-based assessments that support supply chain resilience decisions.
- Translate complex scientific, manufacturing, and supply chain information into clear recommendations, implementation approaches, and decision-support materials.

**Project Leadership and Matrixed Team Coordination**

- Serve as the technical implementation lead for defined project workstreams, with responsibility for coordinating scope, timelines, quality expectations, and deliverables.
- Lead matrixed technical contributors, including internal subject matter experts, external collaborators, and project management partners.
- Translate project priorities into actionable workplans that are technically credible, operationally feasible, and aligned with resources and constraints.
- Track progress, manage follow-up actions, monitor risks and dependencies, escalate issues, and support timely completion of project milestones.

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

- Ph.D. in Organic Chemistry with minimum 5 years of industrial experience in API or fine chemical industries; or M.Sc. in Organic Chemistry with minimum 10 years of industrial experience in API or fine chemical industries.
- Demonstrated independence, broad workstream ownership, and strong matrix leadership across execution-focused technical programs.
- Hands-on experience in laboratory-based process development, route assessment, optimization, scale-up, characterization, or troubleshooting for APIs, fine chemicals, NCEs, or related target molecules.
- Strong foundation in synthetic organic chemistry, modern analytical techniques, reaction monitoring, process optimization, and practical route selection for API or fine chemical development.
- Demonstrated ability to conduct independent literature reviews, design or assess synthetic routes, evaluate reagents and raw materials, and develop technically feasible experimental or implementation plans.
- Demonstrated ability to synthesize scientific, manufacturing, quality, regulatory, and supply chain information into practical recommendations and implementation plans.
- Experience planning and delivering technical work in accordance with project scope, quality requirements, timelines, budgets, and applicable documentation standards.
- Ability to lead matrixed teams, influence without direct authority, and integrate technical, operational, and programmatic perspectives.
- Strong written and oral communication skills, including the ability to prepare technical reports, briefing materials, SOPs, protocols, and project deliverables.

**Additional Desired Preferences**

- Experience in one or more funded technical programs, including donor-funded, government-funded, or internally funded initiatives.
- Experience in pharmaceutical manufacturing and supply chains, API process development, route scouting, scale-up, technology transfer, CMC, quality, GMP manufacturing, or advanced manufacturing technologies.
- Exposure to relevant technical areas such as flow chemistry, process analytical technologies, continuous manufacturing, catalysis, biocatalysis, green chemistry, data science, cheminformatics, or technoeconomic analysis.
- Experience with technical due diligence, risk-based evaluations, supplier assessments, route evaluations, scientific reports, publications, patents, presentations, or other high-quality technical documentation.
- Demonstrated interest and capability to take on increasing responsibility across complex technical programs and execution-focused initiatives.

**Supervisory Responsibilities**

No.

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

**Compensation:**

Base Salary Range: **USD $**  **126,250**  **– $176,509.00** annually.

Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

**Job Category** Technical Programs

**Job Type** Full-Time

Senior Director, Global Manufacturing Programs

**Description**

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

**The Senior Technical Director, Global Manufacturing Programs** **has the following responsibilities:**

**Technical Leadership and Delivery:**

- Provide end-to-end technical leadership on MedSuRe and other assigned programs across manufacturing programs, setting technical direction and ensuring alignment with approved program strategies and donor objectives.
- Oversee technical execution through matrixed teams, ensuring delivery against milestones, quality standards, and performance expectations.
- Establish and uphold technical standards, governance frameworks, and best practices to ensure consistency, rigor, and scalability across programs.
- Proactively identify, assess, and mitigate risks, escalating critical issues to the Department Head when necessary.
- Monitor and report on technical performance, milestones, and risks, providing clear visibility to leadership.
- Drive continuous improvement across technical approaches and delivery models to enhance efficiency and impact.

**Strategic Execution and Portfolio Integration:**

- Translate organizational and donor-driven strategies into actionable program plans, including work plans, milestones, and resource alignment.
- Ensure coherence and integration across technical workstreams to enable efficient, coordinated execution.
- Contribute to program prioritization and resource planning in partnership with the Head of Global Pharmaceutical Programs.
- Ensure all technical outputs meet high standards of quality, compliance, and relevance to global health manufacturing objectives.

**Stakeholder Engagement and Representation:**

- Serve as a senior technical representative in engagements with donors, partners, and external stakeholders, leading or contributing to technical discussions and program reviews.
- Support and, where appropriate, lead donor communications related to technical progress, performance, and risk management.
- Represent the organization in external forums, positioning its technical expertise and advancing its reputation in global health manufacturing.
- Lead or contribute to the development of technical strategies for proposals and new initiatives, ensuring alignment with organizational capabilities and market needs.

**Team Leadership and Collaboration:**

- Lead and mentor multidisciplinary, geographically dispersed teams through matrixed structures, fostering accountability, collaboration, and high performance.
- Provide technical guidance and coaching to strengthen the team's capabilities and ensure the consistent application of standards and best practices.
- Promote a culture of rigor, continuous learning, and excellence across all technical and programmatic activities.

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

- Advanced degree (Ph.D. or MS) in Pharmaceutical Sciences, Chemistry, Public Health, or a related field.
- Minimum of 12 years of experience, including leadership experience within pharmaceutical, biotech, or advanced manufacturing environments, with a strong understanding of drug development and commercialization processes.
- Deep understanding of manufacturing processes, including technology transfer, scale-up, and process validation, as well as regulatory approval pathways, and route-to-market strategies within regulated environments.
- Proven experience leading complex programs or portfolios, including managing risk, dependencies, and technical complexity across concurrent workstreams.
- Demonstrated success leading cross-functional, matrixed teams, aligning diverse stakeholders, and coordinating multiple workstreams to deliver against shared objectives and timelines.
- Strong stakeholder management and executive communication skills, translating technical work into clear impact narratives.
- Ability to resolve conflicts and drive alignment across senior technical teams.
- Understanding of the challenges and operating contexts associated with low- and middle-income countries (LMICs), with experience in, or exposure to, relevant markets considered a plus.

**Supervisory Responsibilities:**  Yes.

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

**Compensation**

Base Salary Range: USD $200,812.00 – $286,157.00 annually.

Target Annual Bonus: 13%/Varies based on role level.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd-party recruitment agencies and is not responsible for fees incurred by recruiters or other agencies, except under a specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

**Job Category** Technical Programs

**Job Type** Full-Time

Technical Advisor, Advanced Supply Chain Solutions ( Fixed Term)

**Description**

**Who is USP?**

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

**Brief Job Overview**

USP seeks a scientific and technical expert with demonstrated experience in active pharmaceutical ingredients, fine chemicals manufacturing, and associated supply chains, combined with strong technical writing capabilities. This non-laboratory, individual contributor role will apply expertise in pharmaceutical manufacturing and supply chains to evaluate manufacturing processes, assess supply vulnerabilities, analyze technical and market information, and develop practical, evidence-based recommendations for essential medicines. The role will analyze APIs, key starting materials, and excipients; identify manufacturing and supply vulnerabilities; and translate findings into technically sound recommendations, including alternative synthetic routes and advanced manufacturing approaches. The advisor may support multiple donor-funded projects and will be responsible for high-quality technical deliverables completed in accordance with project timelines and applicable quality management procedures.

**THIS IS A 2 YEARS FIXED TERM POSTION**

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

This role strengthens USP’s ability to identify and address pharmaceutical manufacturing and supply-chain vulnerabilities affecting essential medicines and products. By translating complex chemical, manufacturing, market, and supply-chain information into clear risk assessments and actionable recommendations, this role will support evidence-based decision-making, technically credible interventions, and high-quality delivery across multiple projects.

**The Technical Advisor has the following responsibilities:**

**Technical Assessment and Analysis**

- Collect, validate, and analyze complex chemical, manufacturing, and supply-chain data to identify risks, gaps, and technically relevant conclusions.
- Evaluate API and KSM manufacturing processes, sourcing structures, supply-market dynamics, and cost drivers; conduct chemical-process technoeconomic analyses; and identify opportunities to improve supply resilience and manufacturing feasibility
- Conduct structured literature and database reviews to assess manufacturing processes, synthetic routes, suppliers, technologies, and relevant technical evidence.
- Integrate data and scientific judgment to assess manufacturing and supply risks and recommend technically feasible mitigation options, including alternative synthetic routes, process improvements, or advanced manufacturing approaches.

**Scientific Writing and Project Delivery**

- Develop clear, evidence-based technical assessments, risk profiles, scientific reports, briefing materials, and recommendations tailored to technical and nontechnical audiences.
- Contribute pharmaceutical manufacturing and donor-funded expertise by working closely with chemists and data scientists to align with project goals and meet required implementation timelines.
- Plan and deliver assigned technical workstreams and deliverables in accordance with project scope, quality requirements, timelines, and budget parameter.
- Collaborate with supply-chain specialists, data scientists, project leaders, and other technical experts to integrate scientific findings into project-level risk assessments, recommendations, and implementation approaches
- Prepare SOPs, protocols, reports, and related project documentation.
- Review records and documents.

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

- Ph.D. in Organic Chemistry with minimum 2 years of industrial research experience in API or fine chemical industries; or M.Sc. in Organic Chemistry with minimum 5 years of industrial research experience in API or fine chemical industries.
- Demonstrated scientific and technical writing experience, including the ability to synthesize evidence and develop clear technical assessments, reports, and recommendations.
- Experience conducting independent literature searches, database reviews, and evidence synthesis related to pharmaceutical manufacturing, synthetic routes, suppliers, or technologies.
- Strong analytical, problem-solving, written, and oral communication skills.
- Ability to work independently and collaboratively in a matrixed team environment.

**Additional Desired Preferences**

- Donor-funded project experience.
- Flow chemistry and PAT.
- Data science/cheminformatics.
- Broader pharmaceutical/fine-chemicals market and supply-chain knowledge.

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

**Compensation:**

Base Salary Range: **USD $**  **126,250**  **– $176,509.00** annually.

Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

**Job Category** Technical Programs

**Job Type** Full-Time

Supervisor, Warehouse - SDF - Night shift

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Manage all of the shipping/receiving activities and material handling activities & material movements within the site, with an emphasis on timeliness & accuracy, continual improvement & compliance with cGMPs.

**Relationships**

Reports to Manager.

**Essential Functions**

- Manage receipt of all incoming materials to the site
- Manage shipment of all materials from the site to all customers
- Coordinate scheduling of incoming/outgoing shipments with couriers/transport companies
- Manage flow of materials between the warehouse & production within site
- Maintain & develop department procedures/SOP’s according to cGMP’s
- Develop/track internal metrics to measure department performance
- Implement corporate initiatives for shipping/receiving and material handling
- Improve customer feedback through frequent communication with internal & external customers
- Continually improve shipping/receiving and material handling processes
- Supervise shipping & receiving personnel (promote employee development, review/evaluate/improve performance, etc.)
- Implement cLEAN® principles in all shipping/receiving functions; demonstrate a cLEAN® mindset
- Establish & maintain good & effective communication with all stakeholders
- Resource allocation to provide an adequate level of production support
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May require corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

**Development Of People**

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

**Minimum Qualifications**

- Bachelor's Degree from an accredited university required or an equivalent combination of education & experience
- May consider an Associate’s Degree or relevant field of study from an accredited university with a minimum of five (5) years of experience in a manufacturing or warehouse environment
- May consider a High School Diploma or GED with a minimum of seven (7) years of experience in a manufacturing or warehouse environment
- Experience with ERP/MRP systems required (SAP) required

**Preferred Qualifications**

- Minimum of three (3) years of shipping/receiving or material handling experience required, pharmaceutical industry preferred
- Project Management experience a plus
- Strong working knowledge of database management systems preferred
- Professional import/export experience (e.g. certified freight forwarder) preferred
- Excellent verbal & written communication skills; good presentation skills preferred
- Proven process improvement & problem-solving skills (Green Belt certification preferred) preferred
- Kanban / Lean manufacturing experience preferred
- Knowledge of cGMP & FDA regulations a plus
- Able to develop & manage action plans to achieve targets preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Process Engineering Technician- Nights

**About the Department**

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Improve & support systems/equipment reliability & performance in core processes. Support Process Engineers in process performance & reliability improvements. Based on assigned site and department, will either support the assigned local site or travel globally to other aseptic manufacturing sites to support shutdown activities.

**Relationships**

Reports to Manager/Senior Manager.

**Essential Functions**

- Event & process analysis via root cause analysis (RCA) tools & techniques
- Implement / maintain reliability centered maintenance (RCM) within core processes
- Development & implementation of equipment reliability improvement projects
- Maintain standards for procedures & maintenance plans
- Design / Re-design / Evaluation / Optimization of systems & equipment
- Support and/or execution of Engineering studies, testing (FAT’s, SAT’s) & validation protocols
- Coaching Process Maintenance Technicians
- Systems trainer
- Other accountabilities as assigned
- Execute shutdown activities (preventive maintenance, overhauling stations, support return to operation)
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role. Ability to travel up to 10% for site assigned role. Ability to travel up to 50% for global support assigned role

**Qualifications**

- Associate's Degree in a relevant technical field of study from an accredited university with a minimum of two (2) years of related technical experience required
- In lieu of an Associate’s Degree with a minimum of two years of (2) experience, may consider a High School Diploma or equivalent with a minimum of four (4) years of related technical experience required
- Proven practical experience in both equipment maintenance & process improvements required
- Experience with engineering, validation, manufacturing/pharma manufacturing and/or experience in formulation preferred
- Experience in LEAN and/or Six Sigma preferred
- Demonstrates knowledge in the following systems: Instrument & electrical, mechanical, process improvement methodologies, pharmaceutical utilities, process development, product transfer & chemical properties preferred
- Knowledgeable in controls & control systems, e.g. SCADA, PLC, PCS & BMS preferred
- Experience with MS Office applications like Word, Excel, PowerPoint, etc. preferred
- Proven expertise in planning/organization/execution of maintenance/production/process activities, following up on results & revising the work plan for complex problems being resolved by cross functional teams preferred
- Proven experience with project planning, execution & management preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Manufacturing Operator I (C Shift)

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Operate manufacturing equipment to achieve production goals.

**Relationships**

Reports to Shift Manager.

**Essential Functions**

- Setup, operate, monitor & control equipment, systems & processes
- Clean & sanitize manufacturing, filling & packaging rooms & equipment per SOPs
- Execute production schedule to achieve production goals
- Handle labeling & components correctly; transferring, counting, FIFO, returns, etc
- Participate actively in & support event response
- Read & follow SOPs, job instructions & other documents to ensure compliance
- Identify, report & resolve quality issues
- Assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
- Record/review production data in BPR & associated forms
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

**Qualifications**

- High School Diploma or Equivalent required
- Associate’s Degree or Bioworks Certification preferred
- Minimum of one (1) year of experience in pharmaceutical solid dose manufacturing or other FDA regulated industry preferred
- Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail required
- Computer literacy including use of Microsoft Office suite programs required
- Basic mechanical skills preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.