Quality

Syngene International Ltd

Principal Scientist– Quality Control Microbiology Lead

**Job Title:** Principal Specialist – Quality Control Microbiology Lead

**Reporting to:** Head of Quality Control or Head of Quality

**Department:** Quality Control

**Location:**  Baltimore, Maryland

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, and Merck KGaA. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

*At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.*

Job Summary

The Principal Specialist – Quality Control Microbiology (QC Micro) Lead, will serve as the Lead for the Microbiology side of the QC unit at a large molecule manufacturing plant. This role is critical to ensuring that QC Microbiology functions are aligned with regulatory requirements, company objectives, and industry’s best practices. The incumbent will be accountable for overseeing the QC Microbiology team, working under the Head of Quality Control or Head of Quality in Baltimore. The incumbent will lead the QC microbiology strategy for the site, interface with client counterparts, and partner cross-functionally with Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness. This role is a working Lead Specialist role, and will include hands-on QC work, including sampling and testing, as well as being the lead of the other analysts and specialists within QC Microbiology group.

.

Primary Responsibilities

- Responsible for Quality Control (QC) Microbiology operations, including product support for stability studies, raw material, microbiology lab and packing material testing, ensuring compliance with Good Laboratory Practices (GLP) and applicable regulatory requirements.
- Manage the Environmental Monitoring program for the Bayview Baltimore site, including the Environmental Monitoring Process Qualification (EMPQ), such as drafting the protocol, execution of the EMPQ, and completing the report, followed by designing and maintaining the routine EM program. Draft protocol, execute, and complete report for WFI qualification, followed by designing and maintaining the routine WFI program.
- Manage routine microbiological tests on raw materials, on intermediate and finished products, and for facility utilities, such as water, gas, and environmental sampling.
- Operate as the lead specialist in performing routine sampling and testing for all microbiological tests, including for utility, raw material, in-process and product, stability, and environmental monitoring.
- Draft, execute, and review/approve the Contamination Control Strategy (CCS).
- Draft, execute, and review/approve the Disinfectant Efficacy Study.
- Coordinate with Quality Assurance (QA), and other departments to ensure development and transfer of microbiological tests and methods.
- Ensure qualification, validation, performance, and transfer of microbiology methods within the Biologics department.
- Interact with clients and project teams to ensure seamless execution of project-related activities.
- Ensure all QC test methods, protocols, and technical reports related to Microbiological operations comply with current pharmacopeial and regulatory requirements.
- Collaborate with the Biologics Process Development team to plan and execute testing activities in support of drug substance development and manufacturing.
- Ensure that laboratory incidents, out-of-specifications (OOS), deviations, out-of-trend (OOT) results, and client complaints related to QC testing are thoroughly investigated, root causes identified, and corrective and preventive actions (CAPA) implemented in a timely manner.
- Ensure all documentation, including SOPs, IOPs, EOPs, and STPs, is periodically reviewed, updated, and maintained as per the documentation control system.
- Ensure timely completion of QC activities as per project timelines. Update work plans periodically to accommodate changes in project scope, priorities, or timelines.
- Adhere to ALCOA principles of data integrity for self and ensure compliance by team members.
- Establish functional working teams for self-assessment of compliance to SOPs and data integrity standards.
- Ensure preparation and timely closure of audit action plans and escalate concerns appropriately.
- Lead investigations and ensure closure of client and regulatory audit observations related to QC Microbiology.
- Ensure lab safety protocols are followed at all times and resolve technical issues in the QC Microbiology lab effectively.
- Support QC Microbiology in regulatory filings, including Prior Approval Submissions, renewals, updates, and supplements, as required.
- Manage, coach, and develop the QC Microbiology team and contribute to their professional growth.
- Proactively monitor QC microbial trends, complaints, failures, deviations, and changes to identify opportunities for process, system, and product improvements.

Education & Qualifications

- Education: Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required; Master’s degree is desired.
- Subject matter expert in Quality Control within biologics or pharmaceutical manufacturing environments, specifically for large molecule products.
- Regulatory Knowledge: Understanding of USDA and USFDA, ICH, EU, and Health Canada regulations, as well as USP and other pharmacopeial standards relevant to biologics manufacturing.
- Audit Experience: Proven experience supporting regulatory inspections and third-party audits.
- Technical Expertise: Strong working knowledge of biologic analytical techniques and validation of methods.
- Leadership Skills: Demonstrated ability to lead cross-functional teams, build relationships across departments, and foster a culture of quality, compliance, and accountability.
- Training & Development: Skilled in implementing robust quality systems, qualifications and validations and product lifecycle quality management.
- Continuous Improvement: A track record of driving successful continuous improvement projects to enhance efficiency, reduce deviations, and increase product quality.

Additional Competencies:

- Experience in bioanalytical and bioassay methods for monoclonal antibodies and other biologic molecules.
- Plan and manage resources for smooth operations in the QC microbiology lab.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Maryland

Nurix Therapeutics

Senior Scientist, Analytical Development and Quality Control - Early Phase

**_Company_**

*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.*

**Position**

Nurix Therapeutics seeks an experienced Senior Scientist to join the Analytical Development and Quality Control group. The Senior Scientist will lead analytical and QC activities in IND-enabling and early phase clinical studies. The Senior Scientist will develop analytical test methods, characterize drug substance and drug product attributes, identify and characterize technical risk, and collaborate in risk mitigation work. The Senior Scientist will oversee and execute analytical development, validation, and testing both internally and at external CDMO/CRO partners and author relevant sections of regulatory filings.

The ideal candidate must have expertise in chromatographic method development, stability studies, and phase-appropriate validation and control. The ideal candidate should have a record of contribution to first-in-human INDs and experience in vendor oversight..

This position is onsite at Nurix headquarters in Brisbane, CA.

**Responsibilities:**

- Characterization of drug substance and drug product attributes, identification of technical risks, and collaboration towards risk mitigation strategy
- Method development for and analytical characterization of drug substances, drug products, and product stability
- Management and/or execution of method development internally and at CDMOs/CTLs
- Management of method validation, QC testing, and reference standards at CDMOs/CTLs
- Management of forced degradation, long term stability, and predictive stability studies
- Contribution to OOS/OOE/OOT investigations
- Critical review of data, protocols, reports, specifications, and other documentation
- Trending stability data and establishing retest periods/shelf life using statistical methods
- Collaboration in the development of material control strategies and specifications
- Follow cGMP requirements and internal SOPs

**Qualifications:**

- Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)
- Senior Scientist: BS/MS degree with 14+ years or PhD with 8+ years of industrial CMC experience
- Expertise in HPLC method development is essential
- Additional experience in techniques such as gas chromatography, NMR, mass spectrometry, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, and/or FTIR
- Experience in analytical method development and validation
- Experience in management of analytical activities at CDMOs/CROs
- Solid understanding of control strategy, method validation, and retest/expiry
- Experience managing stability programs, reference standards, and retest/expiry
- Familiarity with ICH guidelines, cGMPs, and pharmacopeial chapters
- Familiarity with deviation management and change control
- Ability to critically interpret data and articulate technical concepts in multidisciplinary settings
- Ability to ensure assigned activities are completed in satisfaction of project timelines
- Strong interpersonal skills that foster collaboration within and outside of the organization
- Ability to travel domestically and internationally

**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

**Salary Range: $162K – $186K**

California

Senior Manager, Analytical Development and Quality Control - Drug Product

**Senior Manager, Analytical Development and Quality Control - Drug Product**

*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.*

**Position:**

Nurix Therapeutics seeks an experienced Senior Manager to join the Analytical Development and Quality Control group. The Senior Manager will be responsible for drug product (DP) analytical development, including method development, oversight of method validation at CDMOs, and lifecycle management in support of Nurix’s oncology and inflammation & immunology (I&I) programs.

This position provides technical oversight of analytical method development, validation, and testing conducted at external CDMO/CRO partners. The Senior Manager will author analytical development reports and IND/IMPD/NDA sections and support late-phase tech transfer and validation activities. This role will also contribute to analytical development for new drug products and dosage forms. The Senior Manager will work closely in cross-functional teams to ensure alignment and integration of analytical and QC strategies across development stages.

The ideal candidate will have expertise in chromatographic and dissolution method development, stability studies, and phase-appropriate validation and control strategies, along with demonstrated experience supporting late-phase development and regulatory submissions.

This position is onsite at Nurix headquarters in Brisbane, CA.

**Responsibilities:**

- Lead analytical method development validation and lifecycle management for drug product formulations, including amorphous solid dispersions (ASDs) and lipid-based systems
- Support PPQ activities, commercialization, commercial QC, and lifecycle management for drug product analytical methods and control strategies
- Design and oversee DP development, registration batch, and commercial stability programs, including protocol development and trend analysis
- Author and review DP analytical development reports to support regulatory submissions, and marketing authorization
- Oversee and support analytical activities, including method development, validation, and QC testing conducted at CDMOs and contract testing laboratories (CTLs)
- Contribute to investigations (e.g., OOS, OOE, OOT), root cause analysis and CAPAs
- Perform critical review of analytical data, protocols, reports, specifications, and related documentation
- Trend stability data and support establishment of retest periods and shelf life using statistical methods
- Collaborate in the development and justification of material control strategies and specifications
- Author technical documents, including analytical development reports, specifications, validation and stability protocols/reports, certificates of analysis (COAs), and storage statements
- Author and review analytical sections of regulatory submissions (e.g., IND/IMPD/NDA)
- Collaboratively author responses to health authority requests for information
- Act as a key contributor to multidisciplinary teams, including Chemical Development, Pharmaceutical Development, Regulatory, Quality, Preclinical, Supply Chain, Medicinal Chemistry, and DMPK
- Maintain and organize analytical documentation and data to ensure traceability, data integrity, and inspection readiness
- Follow cGMP requirements and internal SOPs
- Travel up to 5%, as required

**Qualifications:**

- Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)
- Senior Manager: PhD with 8+ years of industrial CMC experience
- Strong experience in drug product analytical development and validation
- Experience with analytical development for amorphous solid dispersions (ASDs) and/or lipid-based formulations
- Experience in CDMO and contract testing lab oversight
- Experience supporting regulatory submissions (e.g., IND, IMPD, NDA) and global regulatory filings
- Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters
- Ability to work effectively in a cross-functional environment
- Strong technical writing skills (e.g., development reports, regulatory documents)
- Ability to manage multiple priorities in a fast-paced environment
- Excellent communication and cross-functional collaboration skills

**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

**Salary Range:** $161,100 – $185,600

**Location:**  Brisbane, CA - Onsite

GenScript

Intern - QA

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**Key Responsibilities**

- Responsible for reviewing of product CoA and any other product release document to ensure it meet the customer requirement.

- Responsible for management of controlled SOP to ensure it meet ISO 9001 requirement.

- Responsible for in-coming material and work closely with key stakeholder to ensure timing testing and release of material.

- Participate in material non-conformance investigation and follow up with procurement timely on the supplier investigation outcome.

- Complete other tasks assigned by the supervisor.

**Key Requirements**

- Diploma / Bachelor’s degree in Biological Sciences or equivalent

- Familiar with the reading and interpreting of SDS-PAGE, LC-MS, HPLC and other protein detection report

- Detail oriental

- Good problem-solving skills

- Good communication skills (verbal and written)

- Good team working skills

**Key Learnings**

By the end of this internship, you will:

- Develop a good understanding of ISO 9001:2015 requirements and the role of a Quality Management System (QMS).

- Gain hands-on experience in critical material management, document control, and product release processes.

- Enhance problem-solving skills by conducting non-conformance investigations using quality tools such as Fishbone Diagrams, 5 Whys, and Root Cause Analysis (RCA).

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Other Non-US

Civica Rx

Quality Systems Specialist (223)

**Job Description:**

The Quality Systems Specialist will join Civica, Inc. (“Civica”) at the Petersburg, Virginia site, bringing knowledge and experience in service to patients and in support of excellence in quality and compliance. The Petersburg site serves as Civica’s fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Responsibilities of the position include, but are not limited to, supporting the execution, coordination, and continuous improvement of site Quality Systems and Compliance across multiple quality system functions. In a cross-trained team environment, the Quality Systems Specialist will contribute to processes including Change Control, deviations, investigations, CAPA, self-inspection, supplier quality, complaints, and other quality system activities, as needed. This role is essential to maintaining compliance with applicable regulatory standards, including current Good Manufacturing Practices, and to supporting inspection readiness and the reliable supply of quality medicines to patients.

**Essential Duties and Responsibilities:**

· Support the execution, coordination, and continuous improvement of site Quality Systems and Compliance within a cross-trained team environment, serving as a primary contact or subject matter resource for assigned areas as needed.

· Perform and support activities across multiple quality system functions, including but not limited to change control, deviations/investigations, CAPA, internal audit/self-inspection, supplier quality, complaints, and related quality processes.

· Review, edit, coordinate, and maintain quality system records and documentation to ensure compliance with cGMP, regulatory, and internal procedure requirements.

· Facilitate or support cross-functional meetings and follow-up activities to help drive timely progress and completion of assigned quality system deliverables.

· Monitor assigned quality system activities for timeliness, completeness, and compliance, escalating issues as appropriate.

· Track, trend, and analyze quality system metrics to support routine reporting, identify issues, and contribute to continuous improvement efforts.

· Apply applicable procedures, regulatory requirements, and quality standards to support consistent execution of quality system processes and resolution of routine and moderately complex issues.

· Build collaborative working relationships across departments to provide day-to-day guidance and promote understanding of quality system requirements and standard processes.

· Author, revise, and support implementation of procedures, work practices, and other controlled documents within area of responsibility.

· Participate in inspection readiness activities, internal audits/self-inspections, supplier quality activities, and regulatory inspection support as needed.

· Support supplier qualification, monitoring, and related quality activities, including participation in investigations, audit CAPA follow-up, and quality agreement support, as applicable.

· Support the management of complaints and pharmacovigilance-related records and activities, as applicable, in accordance with site procedures and health authority requirements.

· Identify risks, raise quality concerns appropriately, and work collaboratively with cross-functional partners to implement practical, compliant, and risk-based solutions.

· Provide informal guidance, training, and knowledge sharing to peers and new team members across the Quality Systems team.

· Continue building functional and technical expertise across quality systems to support team flexibility, process consistency, and business needs.

· Promote a culture of quality, safety, compliance, and continuous improvement in all activities.

**Basic Qualifications and Capabilities:**

· Bachelor’s Degree in scientific discipline a minimum of 4+ years of combined technical experience in a GMP related field within a pharmaceutical, biologics, or medical device manufacturing facility.

· Experience with Quality systems and demonstrated working knowledge in areas such as material/process controls, supplier quality management, audits, change control, deviation, CAPA, Management Review.

· Experience with cGMPs and Quality System regulatory requirements.

· Experience with Quality computerized system applications (e.g., Veeva, Deacom) or similar systems.

· Works on multiple assignments in collaboration with various department system owners.

· Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment.

· Ability to communicate and work independently with scientific/technical personnel.

· Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

· Strong organization, and execution skills with attention to detail.

· Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.

· Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

**Physical Demands and Work Environment:**

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

Virginia

AbbVie

Scientist II, Product Quality & Occupational Toxicologist

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

Genetic, Environmental, and Occupational Toxicology (GEO Tox) is a diverse team of scientists with the goals of supporting patient, environmental, and employee safety. The candidate will support risk assessments for occupational, environmental, manufacturing, and product regulatory filings. The position will support programs across AbbVie’s therapeutic areas and involve a broad range of modalities across all stages from early discovery throughout development to marketed products.

We are seeking an early career toxicologist to join our team in Development Sciences, Pre-clinical Safety.

**Responsibilities**:

- Critically evaluate literature and toxicology reports/summaries and utilize tools such as read-across and *in silico* data to generate toxicology risk assessments including extractables and leachables, health-based exposure limits (HBELs) including permitted daily exposure limits (PDEs) and occupational exposure limits (OELs).
- Support product quality toxicology risk assessments to support non-conformances and product complaints.
- Experience supporting medical devices and combination products under ISO 10993.
- Successful collaboration with multi-functional teams to align on safety and compound hazard classifications banding for implementation throughout the company.
- Support occupational health (hazard) categorizations and chemical registrations, including Globally Harmonized System of Classification and Labelling of Chemicals GHS/CLP, and Safety Data Sheets (SDS).

Qualifications

**Requirements**:

- Bachelor degree in toxicology, pharmacology, or related science with typically seven years of experience, or Master degree with 5 years of relevant experience
- Understand relevant scientific literature and apply theoretical framework to execute tasks/projects in a timely manner
- Minimum of 3 years experience in a pharmaceutical/biopharmaceutical, GMP/GLP, or other regulatory setting desired
- Exceptional collaboration, multi-tasking, and communication skills
- Excellent writing skills and attention to detail
- Ability to work in a fast-paced environment, comfortable with multitasking to meet project deadlines

**Desired skills:**

- Risk assessment authoring experience
- Toxicity data mining in relevant databases, internal, and external literature for use in compound risk assessments, classification, and labelling.
- Knowledge and/or experience with regulatory guidance, i.e., ISO, ICH, etc.
- Proficiency in Microsoft Office and other computer software systems

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>)

Illinois

Frederick National Laboratory for Cancer Research

cGMP Maintenance Mechanic (3rd shift)

**cGMP Maintenance Mechanic (3rd shift)**

Job ID: req4715

Employee Type: nonexempt full-time

Division: Vaccine Clinical Materials Program

Facility: Frederick: G-WAY

Location: 7116 Geoffrey Way, Frederick, MD 21704 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 Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

**KEY ROLES/RESPONSIBILITIES**

- Work hours for this position are 10:30 p.m. to 7:00 a.m., weekdays.
- Performs routine inspections, basic troubleshooting, and minor maintenance and repairs within the scope of the position, following established procedures and applicable safety requirements.
- Moves, repositions, assembles, and installs small equipment and facility items using appropriate hand and power tools and approved material-handling methods.
- Uses appropriate hand tools, power tools, and shop equipment to perform routine maintenance, minor repairs, and light fabrication as needed.
- Supports the integrity and reliability of Vaccine Pilot Plant (VPP) utility and support systems through routine inspections, preventive maintenance, alarm response, and appropriate follow-up.
- Works independently during third-shift operations to monitor facility conditions, perform basic troubleshooting and minor corrective actions, and contact appropriate skilled-trade personnel when additional support or major repairs are required.
- Performs minor facility repairs and support work as needed, including shelving, drywall repair, painting, lighting replacement, ceiling tiles, restroom and office repairs, moving or repositioning small equipment, and other general maintenance activities.
- Identifies potential machinery, equipment, and system malfunctions; performs basic troubleshooting; and takes appropriate corrective action or escalates the issue for additional support.
- Performs routine walkdowns and inspections of critical utility and facility support systems, identifies abnormal operating conditions, and responds appropriately or escalates the issue as needed.
- Responds to Scientific Alarms and Building Automation System (BAS) alarms, assesses the condition, and responds appropriately or escalates the issue as needed.
- Maintains clear, concise, and legible equipment logbooks and maintenance records, documenting equipment conditions, maintenance activities, corrective actions, and unresolved issues.
- Maintains radio communication with VCMP Security and the VCMP Facilities Maintenance Department as required during third-shift operations.
- Participates in the rotating emergency on-call schedule, currently assigned approximately every six to eight weeks.
- Follows established Standard Operating Procedures (SOPs), cGMP requirements, safety requirements, and applicable documentation practices when performing maintenance, repairs, inspections, and equipment-related activities.

**BASIC QUALIFICATIONS**

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

- Possession of a High School Diploma.
- In addition to the education requirement, a minimum of minimum of two (2) years of craft-related experience.
- Must possess basic Microsoft Office skills.
- Knowledge of support systems including chillers, steam generation, Scientific and Building Alarm Systems, water purification, water treatment and control systems (electromechanical and pneumatic).
- Ability to start/stop equipment as required.
- Ability to effect minor repairs to a large variety of systems and equipment.
- Ability to follow established procedures.
- Ability to work independently and with other in-house maintenance personnel.
- This position is subject to 24-hour call-in for alarm conditions and breakdown repairs.
- Prior to beginning normal scheduled hours, must have the ability to attend training weekdays between the hours of 7am to 3:30pm. Duration of training to be determined by applicant’s experience and qualifications.
- This position is considered a safety-sensitive position and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program.
- Ability to obtain and maintain a security clearance.

**PHYSICAL REQUIREMENTS**

- Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms, and legs, lift and carry up to 50lb, lift \>50lb, reach above shoulders, climb ladders, push/pull, repeated bending and stand for extended periods.
- Ability to obtain confined space certification.
- Visual acuity to include depth perception, color distinction, and vision correctable to 20/40.
- Ability to wear Personal Protective Equipment (PPE).
- Ability to enter a laboratory or encounter a hazardous area.
- Ability to kneel.
- Ability to operate and/or service equipment that contacts or transports compressed or liquid gas.
- Pacemaker prohibited.
- Repeated bending.
- Exposure to temperatures below 32 degrees indoors for small amounts of time.
- Exposure to temperatures above 90 degrees indoors for small amounts of time.

**PREFERRED QUALIFICATIONS**

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

- Five (5) years' craft related experience.
- Experience with Building Automation Systems (BAS) and facility alarm systems.
- Experience performing maintenance and minor repairs on mechanical, HVAC, utility, facility, or industrial equipment.
- Experience with electrical, electromechanical, pneumatic, and/or control systems.
- Experience working in a cGMP, pharmaceutical, biotechnology, laboratory, or other regulated environment preferred.
- Experience with general plumbing repairs.

**JOB HAZARDS**

- This position is subject to working in or have the potential to exposure to high noise levels for extended periods of time required medical clearance.

**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>)

55,400.00 - 81,600.00 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

Maintenance Technician III (HVAC Controls)

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

Independently perform Senior level technical support within the maintenance department. Trains l0wer-level Technicians on more advanced tasks.

Shift is 6am-2:30pm Monday- Friday

Responsibilities

- • Adhere to Abbvie’s code of conduct
  • Maintains the function of department assets to ensure reliable equipment and quality standards are met.
- • Assists in root cause investigation and reliability centered maintenance analysis
  • Capable of training others on tasks.
  • Is proficient in multiple skilled trade disciplines and creates or edits maintenance job plans
- • Intermediate computer skills (MS Windows)
  • Fully proficient in their core function, performing advanced level tasks
- • Assist cross functional teams outside of the maintenance organization
  • Supports continuous improvement projects and safety initiatives within the maintenance organization and/or the site
- • Understands and follows all safety and GMP regulations
  • Assist cross functional teams outside of the maintenance organization

Qualifications

- • HS diploma with 10+ yrs. Experience or Relevant Certificate with 5+ yrs. experience or Associates technical degree with 3+ yrs. Experience, or proficient in two or more skilled maintenance functions.
- • Knowledge and ability to use advanced tools (i.e. machine tools, diagnostic tools, predictive tools)

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>)

Senior Auditor, Supplier Audit & Compliance

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**:

Primarily responsible for carrying out comprehensive quality system audits of third-party service providers and manufacturers for compliance with applicable global regulatory requirements. Responsible for providing quality

consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide

**Responsibilities**:

- Carry out job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies.
- Independently plan and conduct external supplier audits assessing compliance of systems, facilities, and processes per applicable regulations and AbbVie specifications.
- Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained.
- Assist in maintaining approved supplier list, global audit schedule and participate in supplier management processes (e.g. Management Review, Supplier Change Notifications, etc.).
- Provide guidance and training on GxP regulations and guidelines to audit team members and internal business partners.
- Assist on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers.
- Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities.
- Expected to elevate any issues to management, as necessary, in meeting these responsibilities.
- Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight.
- Participates in strategic initiatives to improve compliance to regulatory requirements and standards.
- Collaborate with AbbVie Operations in coordinating and conduct of joint audits.
- Ensures audits are conducted according to the annual audit schedule.

This is an experienced level compliance position that reports to the Director RDQA External Partners Quality Audit or designee. This individual is expected to identify and resolve problems through effective interpersonal skills. The incumbent will work effectively independently or as a team, mentor others, and also be an effective cross-functional team leader. Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas.

Qualifications

- Bachelor’s degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering).
- Demonstrated strong leadership competencies, proficient level of technical capabilities, and

independence. Proven track record utilizing core & technical competencies.

- 8+ years’ total experience, including 3+ years in compliance or auditing role.
- Sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries and thorough understanding of international GMP and Device regulatory standards (e.g. US FDA, EU, MDR/IVDR, etc.).
- Quality Assurance auditing experience (preferred)
- Pharmaceutical/Device Manufacturing experience (preferred)
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ)
- Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA))

Additional Information

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>)

Lundbeck

Senior Manager Speaker Programs

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

The Senior Manager, Speaker Programs is responsible for the operational management and execution of promotional speaker programs with primary accountability for ensuring programs are delivered efficiently, compliantly, and in alignment with company policies, SOPs, business processes, and applicable industry requirements.

This role serves as the operational lead for speaker program execution and provides oversight across vendor performance, speaker bureau logistics, speaker contracting support, exception management, aggregate spend reconciliation, promotional review submissions, field support, reporting, systems, and process improvement. The Senior Manager partners closely with Commercial, Marketing, Legal, Compliance, Finance, IT, Field teams, and external vendors to resolve operational issues, improvement program effectiveness, and maintain compliant and sustainable speaker program processes.

**Essential Functions:**

**Speaker Program Execution & Vendor Oversight**

- Own end-to-end speaker program operations from program intake planning through execution, reconciliation, documentation, and closeout.
- Oversee vendor performance and execution across logistics, attendee management, reporting, documentation, and ensuring effective service delivery
- Monitor program activity and vendor performance against established expectations, timelines, KPIs, and SLAs; Proactively identify risks or performance gaps, drive resolution, and escalate significant risks as appropriate.
- Ensure programs are executed according with applicable SOPs, business processes, contractual requirements and compliance standards.
- Manage speaker bureau operations including onboarding, contracting coordination, FMV documentation, training requirements, utilization monitoring and ongoing administration.
- Partner with Legal, Compliance, Marketing, Field teams, and external vendors to resolve complex operational issues and ensure timely completion of speaker requirements.
- Identify opportunities and recommend improvements to strengthen vendor performance, program execution, and operation consistency.

**Compliance Operations, Exceptions & Spend Reconciliation**

- Manage the operational process for speaker program exception requests including intake, review coordination, tracking, documentation, resolution, and follow-up.
- Apply sound operational judgement to assess issues, determine appropriate escalation and partner with Legal, Compliance, Finance, Field teams, and vendors to resolve compliance, spend, or documentation concerns.
- Perform reconciliation and validation of speaker-related expenses to support transparency and aggregate spend reporting.
- Maintain complete, accurate, and audit-ready documentation and support QA review of speaker program spend and activity data.
- Analyze recurring compliance, documentation, or process issues and escalate to Compliance. Recommend and support process improvements and remediation activities as appropriate.

**Promotional Review, Reporting & Systems Support**

- Manage and execute submission of speaker program materials into Veeva ensuring submissions meet routing, documentation, and approval requirements.
- Coordinate and execute required updates, re-approvals, and availability of speaker program materials.
- Develop, maintain, and manage speaker program trackers, dashboards, reports, and operational metrics that provide visibility into program activity and performance.
- Prepare and analyze activity, utilization, training, compliance, and vendor performance reporting; Identify trends, gaps, and areas requiring follow-up.
- Leverage program data and analytics to develop recommendations that inform program strategy, operational priorities, resource decisions, and leadership decision-making
- Serve as the operational lead for speaker program portals, vendor systems, data interfaces, and system enhancement activities including troubleshooting and coordination of enhancements
- Identify recurring operational, system, or documentation issues and recommend process, systems, or documentation process improvements to increase efficiency, accuracy, and user experience

**Field Support & Cross-Functional Execution**

- Provide subject matter expertise and operational guidance to field personnel on speaker program processes, timelines, systems, documentation and compliance requirements.
- Maintain effective cross-functional partnerships with Commercial, Marketing, Legal, Compliance, Finance, IT, Field teams, and vendors to support effective and compliant program execution.
- Responsible for stakeholder communications, training, and change management processes.
- Lead cross-functional follow-up to ensure timely resolution of program issues, open items, and operational risks

**Commercial Operations Support & Governance**

- Lead or support for broader Commercial Operations workstreams based on business priorities, including operational tracking, documentation, reporting, governance, and special projects.
- Support governance and execution across related programs such as fleet, stipend, and pharmaceutical sample distribution through vendor coordination, process support, documentation, and issue resolution.
- Partner with Compliance, Legal, IT, Field leadership, and external vendors to support compliant and efficient execution of Commercial Operations programs. Perform additional duties and strategic projects as assigned.
- Evaluate operational processes and program performance to identify opportunities for standardization, simplification, automation, and continuous improvement

**Required Education, Experience, and Skills:**

- Accredited Bachelor’s degree
- 6+ years of relevant experience in compliance, healthcare, life sciences, or related field
- Strong understanding of healthcare compliance regulations (e.g., FDA, PhRMA Code, Anti-Kickback Statute)
- Strong analytical and organizational skills
- Effective communication and collaboration skills
- Detail-oriented with ability to manage multiple tasks
- Proficiency in Microsoft Office (Excel, PowerPoint, Word, Teams)

**Preferred Qualifications, Skills and Competencies**

- Strong preference for candidate to based in Boston, MA
- Exposure to auditing, monitoring, or compliance investigations
- Experience working with data sets and reporting tools
- Basic project coordination experience
- Familiarity with document management systems and compliance tools
- Intermediate Excel skills

**Travel**

- Willingness/Ability to travel up to 20% domestically. International travel may be required.
- If based remotely, additional travel will be required to Boston, MA to meet the needs of the role and the business.

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $140,000 - $160,000 and eligibility for a 15% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis. #LI-LM1

**Why Lundbeck**

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the [U.S. career site](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>).

*Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the* [*U.S. career site*](<https://www.lundbeck.com/us/careers/your-job/eeo-accommodations-policy>).

*Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in* [*E-Verify*](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/E-Verify_Participation_Poster_Eng_Es.pdf>).

Massachusetts

Insmed Incorporated

Senior Analyst, Quality Assurance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

Reporting to the Associate Director, Quality – Analytical, the Senior Analyst is responsible for providing Quality Assurance oversight of internal and external Quality Control activities supporting Gene Therapy programs. This role ensures analytical testing, stability programs, and laboratory operations are conducted in compliance with cGMP regulations, global health authority guidelines, regulatory filings, and company procedures.

You will serve as the primary QA point of contact for assigned products or laboratory functions, independently managing routine quality oversight and laboratory record approvals while escalating complex, high-risk, or strategic matters to QA leadership as appropriate. This position requires a strong quality mindset, technical understanding of analytical testing, and the ability to apply risk-based decision-making to maintain compliant, inspection-ready operations aligned with product lifecycle requirements.

**What You'll Do:**

In this role,you’llhave the opportunity toprovide QA oversight of internal and external QC laboratory operations to ensure compliance with cGMP regulations and global health authority requirements.You’llalso:

- Serve as the QA point of contact for assigned products, stability programs, and/or laboratory functions.
- Review and approve release and stability analytical testing documentation, raw material qualifications, method validation protocols and reports, and equipment qualification documentation. Review and approve SOPs, deviations, investigations, CAPAs, change controls, and supplier notifications.
- Provide QA oversight of OOS, OOT, and atypical laboratory investigations to ensure scientifically sound root cause analysis and compliant documentation.
- Assess quality impact of laboratory events and escalate high-risk, cross-functional, or potentially regulatory-impacting issues to QA management as appropriate.
- Review and approve equipment qualification, calibration and maintenance program.
- Ensure compliance with data integrity requirements, including 21 CFR Part 11 and Annex 11.
- Ensure analytical methods and documentation remain aligned with regulatory filings and current product registrations.
- Track record status and analyze laboratory metrics and analytical trends to support compliance and continuous improvement. Review and approve internal and external analytical method qualification/validation.
- Participate in cross-functional discussions to provide quality input and risk-based recommendations.
- Support internal and external audits, regulatory inspections, and supplier-related quality activities as needed. Partner with QC to drive continuous improvement initiatives and maintain audit readiness.

**Who You Are:**

You have aminimumof a Bachelor's degree in in Chemistry, Engineering, Life Sciences, or a related discipline along with 5+ years of experience in Quality Assurance experience within the pharmaceutical or biotechnology industry, preferably supporting Quality Control operations. You are or you have:

- Experience supporting Gene Therapy and/or biologics experience, a must.
- Strong knowledge of cGMP regulations and global laboratory compliance standards (FDA, EMA, ICH).
- Experience with deviations, investigations, CAPAs, change controls, and method validation oversight.
- Working knowledge of data integrity principles and regulatory expectations, including electronic records and laboratory systems compliance.
- Familiarity with risk management tools (e.g., FMEA) and risk-based decision-making.
- Solid understanding of QC laboratory operations and analytical testing.
- Familiarity with analytical techniques such as HPLC/UPLC, CE-SDS, Cell Based Potency Assay, ddPCR, ELISA, Microbiology safety assay and related methodologies.
- Experience with quality and laboratory systems (e.g., Veeva, LIMS, Chromeleon, BMRAM or equivalent).
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
- Strong analytical thinking and sound judgment. Highly organized with strong attention to detail, accuracy, and clarity.

**WhereYou’llWork**

This is a hybrid role based out of ourSan Diego office.You’llhave theoptiontowork remotely with in-person collaboration3 -4 days a week.

**Travel Requirements**

This role requires occasional travel (approximatelyup to 20%).

\#LI-hybrid

\#LI-EG1

**Pay Range:**

$100,000.00-126,500.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

Senior Director, DSPV Quality, Training & Compliance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Senior Director, DSPV Quality, Training & Compliance to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Global Head of DSPV, the Senior Director will be responsible for oversight of the Drug Safety and Pharmacovigilance (DSPV) quality and compliance framework, supporting the ongoing effectiveness, inspection readiness, and regulatory compliance of the PV function.

Through the aggregation and evaluation of compliance information across the PV system, the role supports both the Head of Pharmacovigilance and the EU/UK QPPV in maintaining effective oversight of the PV system and driving continuous improvement. This individual will be a key member of the DSPV Leadership Team and will partner closely with Insmed Quality.

**What You'll Do:**

In this role, you’ll have the opportunity to enable the oversight of PV activities through compliance monitoring, quality event, deviation, and CAPA management, inspection readiness, audit follow-up, procedural governance, training compliance, trend analysis, and management reporting. You’ll also be responsible for:

**Pharmacovigilance Compliance Oversight**

- Maintain and continuously improve the PV compliance monitoring program, providing independent monitoring and governance support to DSPV leadership and the EU/UK QPPV, and ensuring appropriate escalation of significant issues and emerging risks.
- Serve as the primary DSPV liaison to Quality for PV-related compliance and quality system activities, and partner with DSPV Business Process Owners to oversee vendor performance, compliance risks, quality events, and remediation.

**PV System Monitoring**

- Establish and govern DSPV standards for compliance monitoring, KPIs, and quality metrics; aggregate and analyze Business Process Owner metrics; and oversee quality and compliance dashboards.
- Trend performance, deviations, CAPAs, audit findings, inspection observations, and other quality indicators to identify recurring issues and systemic risks and communicate insights on PV system effectiveness to DSPV leadership and governance forums.

**Training and Procedural Governance**

- Own the DSPV training framework, curricula governance, competency development, and training compliance program, partnering with Business Process Owners, HR, and DSPV leadership to support capability building, professional development, and role-based learning.
- Oversee the lifecycle of DSPV standards, SOPs, work instructions, and controlled documents, including development, review, approval, periodic review, version control, and archival; partner with Business Process Owners to ensure procedures, training, and performance measures remain compliant, harmonized, effective, and aligned with DSPV standards.

**Audit and Inspection Readiness**

- Partner with Quality to coordinate DSPV preparation and participation in regulatory inspections, audits, and due diligence assessments.
- Lead tracking of audit findings, inspection observations, and associated CAPA plans, and analyze outcomes to identify trends, improvement opportunities, and compliance risks.

**Quality Event, Deviation, and CAPA Management**

- Partner with Quality to ensure effective management of PV-related quality events, deviations, and CAPAs, including those arising from audits and inspections.
- Facilitate root cause analysis and preventive action development and trend quality events and CAPAs to identify recurring issues and systemic process weaknesses.

**Continuous Improvement**

- Collaborate with Quality to strengthen PV compliance and inspection readiness, recommend improvements to process compliance, governance, and monitoring, and promote a culture of quality, accountability, and continuous improvement.
- Partner with the EU/UK QPPV Office and Regulatory Intelligence sources to independently oversee DSPV Business Process Owners’ assessment, implementation, and effectiveness monitoring of regulatory-driven changes impacting DSPV.

**Who You Are:**

You must have a Bachelor’s degree in a life sciences discipline and 10+ years of experience in pharmacovigilance. Additionally, you have:

- 3+ years of experience in a quality or compliance leadership role.

- Demonstrated experience managing global pharmacovigilance inspections conducted by major health authorities.

- Deep knowledge of global PV regulations and guidelines (FDA, EMA, ICH).

- Strong track record of building and leading teams in a fast-paced, dynamic environment.

- Experience in a small or mid-size biopharma environment.

**Nice to Have (but not required):**

- Advanced degree (MS, PharmD, PhD) strongly preferred.

- Experience in both clinical and commercial stage environments preferred.

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to yourInsmedteam and community.Occasional travel for team meetings or eventswillbe expected.

**Travel Requirements**

This position involves occasional domestic travel for face-to-face Leadership Team meetings (approximately 5-10%).

\#LI-Remote

\#LI-MM

**Pay Range:**

$222,000.00-303,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

Nationwide

Senior Manager, Clinical Supplier Quality

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

The Senior Manager, Clinical Supplier Quality is responsible for leading and overseeing supplier quality management activities supporting global clinical suppliers across development programs. You will serve as a key supplier quality partner to cross-functional stakeholders (e.g., Clinical Operations, Clinical Development, Biometrics, Bioanalytical, etc.) and external service providers to ensure compliance with global regulatory requirements and Insmed’s quality standards. You will administer the Supplier Management Program in partnership with DevQA, supporting supplier qualification, escalation management, quality data and performance trend monitoring, and quality agreement management for clinical suppliers supporting development programs.

**What You'll Do:**

In this role, you’ll have the opportunity to partner with DevQA to lead qualification, onboarding, risk assessment, and lifecycle management activities for clinical suppliers and service providers, ensuring compliance with global regulatory requirements and risk-based oversight principles, while assessing supplier capability, quality systems, and compliance against internal and external standards.

You’ll also:

- Collaborate and lead discussions with procurement, supply chain, DevQA and cross-functional SMEs to evaluate supplier performance history, support supplier selection, and execute qualification strategies for new and scope expansions of existing suppliers.
- Maintain and govern the approved supplier list and qualification records, ensuring appropriate risk-based controls are defined and applied throughout the supplier lifecycle in alignment with business and regulatory expectations.
- Maintain the supplier escalation programs to ensure that issues are getting elevated to the right levels at Insmed and within the Supplier’s organization to ensure we are addressing and solving issues effectively in a timely manner.
- Partner with DevQA to develop, manage, and continuously improve supplier performance monitoring frameworks for clinical suppliers in collaboration with the functional representatives, including KPIs, scorecards, and quality metrics, ensuring accurate risk-based scoring, timely completion, and appropriate control alignment.
- Support supplier quality event management and continuous improvement activities, including deviations, investigations, change controls, CAPAs, and development of supplier quality procedures, policies, templates, and governance frameworks.
- Analyze supplier quality data and performance trends, including deviations, CAPAs, audit findings, inspection outcomes, data integrity issues, and timeliness metrics, and facilitate, in collaboration with functional representative supplier governance forums and business reviews to drive remediation actions, corrective measures, and continuous improvement while maintaining accurate supplier records and approved supplier listings.
- Ensure supplier quality systems comply with global regulations, ICH guidelines, internal SOPs, and industry standards, while driving adherence to ALCOA+ data integrity principles and ICH Q9 risk management methodologies across outsourced activities.
- Provide support to inspection readiness activities for suppliers, and participating in Health Authority inspections (including FDA, EMA, MHRA, PMDA, and Health Canada).
- Support the audit program by conducting audits of suppliers and providing subject matter expertise through peer review, consultation on audit findings, and input on criticality assignment, ensuring that audit outputs remain objective, evidence based, and aligned with applicable regulatory standards.
- Own and manage the global clinical Quality Technical Agreement (QTA) program, including development, negotiation, execution, maintenance, periodic review, and renewal of Quality Agreements to ensure clear definition of GxP responsibilities, quality oversight, escalation pathways, data integrity expectations, inspection support obligations, and alignment with evolving regulatory and business requirements.

**Who You Are:**

You have aminimumof a Bachelor's degree in Chemistry, Engineering, Life Science or related discipline as well as a minimum of 12 years of direct experience supporting GCP regulated activities.

You are or also have:

- Strong experience managing supplier quality programs for clinical and nonclinical outsourced service providers.
- Demonstrated experience with GCP Supplier oversight, GCP audits, Supplier qualification, CAPA management and Risk management.
- Quality Fundamentals: Deep understanding of ICH GCP guidelines, data integrity principles, and risk management methodologies (e.g., RBQM).
- Experience working within global clinical development environments.
- Strong working knowledge of global GCP regulations and guidelines, including FDA 21 CFR Parts 11, 50, 54, 56, and 312, ICH E6(R3), ICH E8(R1), EU Clinical Trials Regulation (EU) No. 536/2014, EU Annex 11, MHRA GCP guidance, EMA inspection expectations, and Health Canada clinical trial requirements.
- Certification in GC.
- Act in a highly organized manner with a strong attention to detail, clarity, accuracy, and conciseness.
- Proven influencing and negotiating skillset.
- Highly proficient in data analytics, critical thinking, and decision-making concepts.

**Nice to have (but not a must):**

- Experience supporting GLP regulated activities. Understanding of GLP regulations and laboratory compliance frameworks, including FDA 21 CFR Part 58, OECD Principles of GLP, EPA GLP requirements (where applicable), WHO GLP guidance, and data integrity and computerized systems expectations in laboratory environments.
- GLP auditing or clinical research.
- Prior people leadership experience. .

**WhereYou’llWork**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community.Occasional travel for team meetings or eventswillbe expected.

**Travel Requirements**

Up to 20% domestic and international travel based on supplier requirements.

\#LI-EG1

\#LI-remote

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

Summer Intern – CMC Quality Assurance, Clinical Programs

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Summer Intern – CMC Quality Assurance, Clinical Programs on the Quality Assurance Team to help us expand what’s possible for patients with serious diseases.

The Insmed Summer Internship Program is designed to give you more than just a glimpse into the pharmaceutical industry—it’s a chance to make a real impact. Over the course of the summer, you’ll gain hands-on experience, contribute to meaningful team projects, and learn directly from skilled professionals who are invested in your growth.

Our 2027 Summer Intern program is a full-time (40 hours per week), 12-week, paid internship. The internship may present opportunities for rotational assignments within the function, and the intern will be assigned goals and objectives that will support the strategic business plan of the company.

**What You'll Do:**

In this role, you’ll have the opportunity to support Quality Assurance activities for Insmed's Phase 1 - Phase 3 clinical programs manufactured at Contract Manufacturing Organizations (CMOs).

You’ll also:

- Assist in designing and developing a QA Metrics Dashboard to improve visibility into quality metrics and operational performance Analyze and compare quality systems across multiple CMOs
- Perform trending and analysis of deviations and CAPAs to identify systemic issues and improvement opportunities across CMOs.
- Assist in organizing batch records and release documentation in Veeva Vault
- Collaborate with stakeholders across departments and geographies (e.g., Supplier Quality, Digital Quality, Commercial) on quality-related initiatives
- Support special projects across the Quality Assurance team, including:
  - Training development
  - Policies and SOPs
  - AI-driven quality initiatives
  - Other strategic projects

**Who You Are:**

You are a current student pursuing a Bachelor’s or Master’s degree in biomedical engineering, Biotechnology, Life Sciences, Chemistry, or related field.

You are or you have:

- Strong willingness to learn, with eagerness to expand knowledge of Healthcare industry
- Interest in pharmaceutical quality systems, clinical manufacturing, and regulatory compliance.
- Ability to work independently and collaborate in a fast-paced environment.
- Effective communication skills (verbal and written) and highly organized with strong attention to detail, clarity, accuracy, and conciseness.

**Nice to have (but not required):**

- Prior internship or project experience in Healthcare compliance, Life sciences or Regulated industries (pharmaceutical, medical devices)
- Experience building AI agents, workflows, or applications

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.

**Pay Range:**

$20.00-35.00 Hourly

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. Our internship program reflects that commitment by supporting how you learn, grow, and show up each day while contributing to work that matters.

Our internship offerings include:

- Paid company holidays
- Hands-on learning in real-world projects
- Networking opportunities with leaders and social events with your peers
- Mentorship and professional development
- A final presentation to celebrate your contributions
- Access to office amenities for those who are not remote

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

[*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

New Jersey

Summer Intern – Quality Systems & Business Processes

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Summer Intern – Quality Systems & Business Processes on the Quality Assurance Team to help us expand what’s possible for patients with serious diseases.

The Insmed Summer Internship Program is designed to give you more than just a glimpse into the pharmaceutical industry—it’s a chance to make a real impact. Over the course of the summer, you’ll gain hands-on experience, contribute to meaningful team projects, and learn directly from skilled professionals who are invested in your growth.

Our 2027 Summer Intern program is a full-time (40 hours per week), 12-week, paid internship. The internship may present opportunities for rotational assignments within the function, and the intern will be assigned goals and objectives that will support the strategic business plan of the company.

**What You'll Do:**

In this role, you’ll have the opportunity to contribute to a project that improves Insmed’s Quality systems and business processes. You’ll gain hands-on experience with digital platforms, analyze data, and develop documentation and resources that support efficient processes and effective system use.

You’ll also:

- Document a selected business process and develop a process map with input from the Quality team.

- Analyze relevant process or system data to identify trends and opportunities for improvement.

- Develop draft user guides, work instructions, or training materials for a selected Quality system or process.

- Assist with user acceptance testing activities, as applicable, by documenting results and tracking feedback under team guidance.

**Who You Are:**

You are a current student working on a Bachelors or Master’s degree in Management Information Systems, Computer Science, Engineering, Chemistry, Biology, or a related field.

You are or you have:

- Strong organizational skills and attention to detail.
- Effective written and verbal communication skills
- The ability to analyze information and summarize key findings.
- Strong teamwork and collaboration skills.
- Comfortable working with digital tools and platforms

**Nice to have (but not required):**

- An interest in Quality systems and the pharmaceutical or biotechnology industry.

**Where You’ll Work**

This is a hybrid role based out of our Bridgewater, New Jersey office. You’ll work remotely most of the time, with in-person collaboration when it matters most.

**Pay Range:**

$20.00-35.00 Hourly

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. Our internship program reflects that commitment by supporting how you learn, grow, and show up each day while contributing to work that matters.

Our internship offerings include:

- Paid company holidays
- Hands-on learning in real-world projects
- Networking opportunities with leaders and social events with your peers
- Mentorship and professional development
- A final presentation to celebrate your contributions
- Access to office amenities for those who are not remote

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

[*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

Packaging/Medical Device Quality Engineer

As a part of the Quality for Combination Products and Medical Devices (CP/MD QA) department, the Combination Product and Medical Device and Packaging QA Associate will represent Quality in global teams involved in design, development, manufacture and regulatory approval of CSL combination products, which include medical device constituent parts developed to enable convenience, monitoring, compliance and effective outcomes for the lives of our patients.

This role is responsible for ensuring that new product development activities for all CSL combination product projects follow a 21 CFR Part 4 compliant quality system. The Medical Device and Packaging QA Staff (Advisor) will serve as a subject matter expert on medical device and combination product requirements in accordance with FDA / MDR regulations, ISO and other standards and industry best practices with the emphasis on Design Control process. This role is involved in quality related activities throughout the entire product lifecycle from product concept through industrialization and post market support.

The medical device and packaging Quality Associate will collaborate with the multiple global functions and manufacturing sites.

**Reports To:** Combination Product and Medical Device QA Lead

**Main Responsibilities and Accountabilities:**

**1**. Serve as Medical Device and Packaging QA Associate on assigned combination product development projects. Work with project leaders and both internal and external team members to ensure that all design development work meets applicable FDA, EU MDR, and other global regulatory requirements. Ensure that design development teams follow the Design Controls process and utilize appropriate quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc.

**2**. Ensure external medical device development and manufacturing partners meet the standards and criteria set by CSL. Support vendor management activities by participating in the audits; reviewing quality or development agreements; monitoring vendor performance.

**3**. Provide regular progress reports and escalate potential risks related to Quality System and/orproject status to Quality management and stakeholders.

**4.** Assist with development and implementation of the quality system compliant with 21 CFR Part 4, MDR and other global requirements. As assigned, propose improvements to the existing processes, update SOPs / WIs / Forms, develop and conduct training on the modified processes.

**5**. Stay abreast of changing regulatory requirements for medical device and combination products.

**6**. Maintain systems / databases related to the combination products, as assigned. Examples may include Applicable Standards List, vendor certificate database, test method validation log.

**7**. Able to conduct root cause analysis and problem solve issues with recommendations.

**Education**

- Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline.

**Experience**

- Requires a minimum of 5 years of experience as a quality, packaging, engineer or manufacturing professional in medical devices or combination products field. May consider candidates with pharmaceutical, biotech, MedTech or other related background.

**Competencies**

- The Medical Device and Packaging QA Staff (Advisor) should have a working knowledge of the medical device and combination product regulations and requirements, at a minimum, 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, relevant FDA guidance, relevant standards and their application in a compliant QMS.
- The Medical Device and Packaging QA Staff (Advisor) should have minimum 2 years practical experience in medical devices R&D Quality: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation/verification (V&V), usability / human factor studies, DHFs, design transfer.
- This role requires effective communication and collaboration skills.
- This role requires assertiveness.
- This role requires problem-solving skills to allow identifying and resolving problems in a timely manner.
- This role requires planning / organization skills to allow prioritizing work activities and using time effectively.
- Experience with developing drug-delivery combination products is strongly preferred. Experience with products that include embedded software, mobile / web apps and other connected health solutions is a plus.

*The expected base salary range for this position at hiring is $115,000 - $136,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.*

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.csl.com/careers/your-well-being>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Associate Quality Engineer, Combination Products

As a part of the Quality for Combination Products and Medical Devices (CP/MD QA) department, the Associate Quality Engineer will support Quality activities in global teams involved in the design, development, manufacture and regulatory approval of CSL Behring combination products. Under the guidance of senior Quality team members, this role supports quality oversight for combination product development activities to ensure compliance with applicable quality system requirements, including 21 CFR Part 4. The role collaborates with cross-functional teams and manufacturing sites to support compliant product development and maintenance activities.

**This role reports to:** Regional Product Development Quality Lead

**Positions reporting into this role:**  This role has no direct reports

**Main Responsibilities and Accountabilities:**

**1.** Serve as Quality Engineer on assigned combination product development projects as a Quality representative.Participate in Design Control activities and support risk management, document reviews, verification and validation planning, change management, and DHF maintenance.Collaborate with project leaders and both internal and external team members to ensure that all design development work meets applicable FDA, EU MDR and other global regulatory requirements. Ensure that design development teams follow the Design Controls process and utilize appropriate quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc.

**2**. Assist with oversight of external development and manufacturing partners. Support vendor management activities by participating in the audits; reviewing quality or development agreements; monitoring vendor performance.

**3**. Support maintenance and continuous improvement of combination product quality systems. As assigned, propose improvements to the existing processes, update SOPs / WIs / Forms, develop and conduct training on the modified processes.

**4**. Identify and communicate quality-related issues and risks.

**5**. Support investigations, CAPAs, nonconformance management, and change controls.

**6**. Participate in internal audits and inspection readiness activities.

**7**. Stay informed on applicable regulations and standards.

**8**. Maintain quality-related systems and databases. Examples may include Applicable Standards List, vendor certificate database, test method validation log

**Education & Experience**

- Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline.
- Minimum 3 years of experience in a quality, engineering, manufacturing, or related technical role within medical device, pharmaceutical, biotechnology, medtech, or combination products industries.
- Working knowledge of 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and EU MDR.
- Familiarity with Design Controls, risk management, V&V, and design transfer.
- Effective communication and collaboration skills.
- Strong organizational and planning skills.
- Analytical and problem-solving skills.
- Ability to work independently on routine assignments while seeking guidance on complex issues.
- Combination product or drug delivery device experience preferred but not required.

*The expected base salary range for this position at hiring is $94,000 - $111,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.*

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.csl.com/careers/your-well-being>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Director of Manufacturing Engineering and Maintenance

**Position Purpose:**  Provide an overview of the responsibilities of the position by providing a summary of the most critical aspects and duties of the position.

The Head of Manufacturing Engineering & Maintenance is a strategic leader responsible for the reliability and lifecycle management of manufacturing assets. This role oversees Calibration & Metrology Engineering, Manufacturing Maintenance, Reliability Engineering, Production/System Owner Engineering, and Shutdown Planning & Scheduling. Key responsibilities support critical operations, including fractionation, bulk production, and packaging, while ensuring equipment readiness and compliance with regulatory standards in the biopharmaceutical sector. The position also requires strong skills in labor relations to foster collaboration within a unionized workforce.

**Reporting Relationships**:

**Role that this position reports to:**  Engineering & Maintenance Site Head

**Role/s that report to this position:**  Engineers, Maintenance, Calibrations, Shutdown Planner

**Main Responsibilities and Accountabilities:**

1. **Engineering Leadership**

- Develop and implement the site engineering and maintenance strategy aligned with CSL enterprise objectives, ensuring optimal asset performance and lifecycle management
- Lead and develop a high-performing organization, fostering a culture of accountability, safety, and continuous improvement
- Direct all aspects of manufacturing engineering and maintenance, including technical support, project management, emergency response, on-call, troubleshooting, and corrective, preventive/predictive maintenance.
- Supports the development and implementation of multi-year strategic plans, capital investment roadmaps, and operational readiness programs for all global sites
- Additionally, you will support capital projects throughout their entire lifecycle, from conception and planning to execution and commissioning, ensuring that each project aligns with organizational objectives and is completed successfully.

2. **Strategy Reliability & Asset Management Vision**

- Develop and execute enterprise-level reliability strategies (RCM, FMEA, PdM, CMMS optimization)
- Enhance the accessibility of assets, maximize operational uptime, and optimize the overall cost performance throughout their lifecycle.
- Analyze equipment failures and lead root cause analysis (RCA) and corrective actions
- Establish asset health monitoring and performance metrics

3. **Continuous Improvement**

- Drive continuous improvement initiatives leveraging Lean, Six Sigma, and reliability-centered methodologies
- Explore and pinpoint areas where automation can enhance efficiency, digitization can streamline processes, and predictive maintenance can optimize equipment performance.
- Additionally, create and monitor KPIs for engineering activities, along with comprehensive dashboards to visualize and track these metrics effectively.

4. **Capital Projects & Technical Execution**

- Support site capital projects, including equipment installation and AMP upgrades,
- Provide oversight for planning and execution of site shutdowns and turnarounds, ensuring adherence to scope, schedule, cost, and safety requirements
- Ensure proper design, qualification, and handover of assets to engineering and maintenance operations

5. **Quality Management & Regulatory Compliance**

- Ensure quality management procedures within manufacturing engineering and maintenance, with a focus on cGMP and GEP requirements, are implemented.
- Leads the site's manufacturing engineering and maintenance organization, ensuring assets and services are in compliance with GMP and regulatory standards and product filings.
- Oversee deviation management, investigation of deviations, and establishment of corrective and preventive actions for critical systems.
- Represent the local manufacturing engineering and maintenance function in regulatory inspections, audits, and ensure areas within the area of responsibility remain audit-ready.

6. **Cross-Functional Collaboration**

- Partner with Manufacturing, Quality, MS&T, EHS, and Supply Chain to support production goals, resolve technical challenges, and improve process performance
- Engage with global and regional leadership, peers at other sites to align manufacturing engineering and maintenance strategies with broader business goals.

7. **Team Leadership & Development**

- Lead, mentor, and develop a diverse, cross-functional team of engineers, maintenance professionals, and quality specialists on site.
- Foster a positive, equitable, and inclusive working environment, emphasizing CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
- Develop succession plans and talent pipelines to ensure organizational resilience and leadership continuity.

8. Perform other duties as assigned by the supervisor, members of the Global Leadership Team, or other authorized leaders in support of evolving business needs and cross-functional collaboration.

**Position Qualifications and Experience Requirements:** Provide the hiring requirements for the specified position, including educational, experiential, and competency requirements.

**Education**

- Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Biochemical, or related discipline) is required

**Experience**

- **12+ years** of engineering experience in Biotech, Pharma, or regulated life sciences.
- **8+ years** leading engineers or technical teams
- Strong understanding of GMP, validation, and regulatory expectations
- Experience with reliability engineering, maintenance strategies, and CMMS systems
- Knowledge of Six Sigma/Lean principles is a plus.
- Knowledge of biotech manufacturing processes (upstream/downstream/fill-finish as applicable)
- Familiarity with automation and digital systems
- Financial experience with high-level budgetary responsibilities is required
- Strategic thinker with the ability to translate complex engineering challenges into actionable programs

**Competencies**

- Strong analytical and problem-solving skills.
- Excellent communication abilities.
- Innovation Leadership
- Technical Expertise in Asset Management
- Data-Driven Decision Making
- Change Leadership & Transformation
- Cross-Cultural Collaboration
- Financial Acumen & ROI-oriented mindset
- Commitment to CSL values, ethical behavior, inclusive teamwork, and modeling a positive, respectful culture.

*The expected base salary range for this position at hiring is $199,000 - $244,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.*

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.csl.com/careers/your-well-being>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Maintenance Technician II (Plumber/Pipefitter)

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 Maintenance Plumber/Pipefitter Technician will inspect, troubleshoot, and maintain piping and plumbing related equipment systems, including sinks, toilets, drains, backflows, fire system maintenance, etc. The technician will work Monday through Friday from 6 a.m. to 2:30 p.m.

**Responsibilities**

- Perform maintenance and repair work in an industrial/commercial setting, including new construction plumbing installation and sprinkler and backflow inspection. In addition, testing, inspecting, and replacing piping and pressure relief devices on production and facility equipment.
- Communicate with customers to identify maintenance problems and evaluate the extent of damage/malfunction.
- Troubleshoot and repair plumbing issues quickly to maintain company time schedules and ensure functionality of equipment.
- Provide training to less experienced technicians to ensure efficient and cost-effective work.
- Follow good manufacturing practices and safe work policies and procedures, adhering to proper compliance, GxP standards and established company policies.
- Other duties as assigned by the Supervisor.
- Must have an Illinois State Plumber's license
- Illinois Backflow tester certified preferred

Qualifications

- Knowledge and ability to use basic power tools and ability to apply proper hand and measuring tools in an industrial setting.
- HS diploma with 5+ yrs. experience or Relevant Certificate with 3+ yrs. experience or Associates technical degree with 1+ yrs. experience.

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>)

Legend Biotech

CQV Supervisor

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **CQV Supervisor** as part of the **Facilities & Engineering** team based in **Raritan, NJ.**

**Role Overview:**

This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV experience, represent CQV work in the regulator and internal audits, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.

**Major Responsibilities:**

- Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
- Manages multiple and complex CQV projects, collaboration with cross functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
- Supports and/or owns technical and quality investigations, CAPAs and corrections.
- Develops and performs any required remediation efforts and associated CAPA plans.
- Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable. acceptance criteria, specifically data integrity.
- Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.
- Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
- Train and support the junior team members on different CQV activities.
- Present CQV work to regulatory and internal audit teams.
- Making decision on corrective action in deviation events.
- Make decisions on technical approach, methodology per applicable procedure.
- Manager approval required for resource assignment, timeline shift, strategic shift and finance related events.
- Other responsibilities as assigned.

**Education**

- A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.

**Experience**

- A minimum of 7 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
- Ability to use following or similar systems for business needs
  - Microsoft suite
  - ERP systems: Maximo, Siemens EMS, Comet, Kneat
  - Testing system: Kaye AVS, Kaye Valprobe

**Skills & Competencies**

- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
- Strong interpersonal and written/oral communication skills. · Ability to quickly process complex information and often make critical decisions with limited information.
- Proficient in applying process excellence tools and methodologies.
- Ability to independently be responsible for a portfolio of ongoing projects.
- Ability to pay attention to details and follow the procedures.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Ability to work with others in a team environment.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
- Ability to identify/remediate gaps in processes or systems.
- Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
- Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.

\#Li-RN1

\#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$110,706 - $145,303 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).