Engineering

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>).

Massachusetts

Global Automation Engineering & Technology Head

**Position Purpose:**

The Global Automation Engineering & Technology Head is accountable for defining and executing the enterprise strategy for GxP manufacturing and laboratory digital systems, including PCS, MES, OT Data Systems, and LIMS platforms. This role provides global lifecycle ownership, governance, and standards for platforms, data, and recipes across manufacturing and QC laboratories, ensuring harmonized, compliant, and future-ready operations. Acting as a Center of Excellence, the position establishes digital roadmaps, oversees Tier 1 project delivery and Tier 2/3 governance, and drives strategic partnerships with suppliers and platform providers. The role interfaces broadly across I&T, Operations, Technical Operations, Quality, and Data Analytics to enable an integrated, data-driven, and innovation-oriented digital ecosystem.

**Reporting Relationships:**

- Role that this position reports to: Global Head Engineering
- Role/s that report to this position:
  - Lab Systems Lead
  - Manufacturing Data Systems Lead
  - Automation Standards, Governance & AI Strategy
  - OT Partner Enablement
  - OT Innovation & Capital Delivery Lead

**Main Responsibilities and Accountabilities:**

**Digital Manufacturing & QC Strategy and Roadmap (Operational Technology Domain)**

- Define and execute the global Operational Technology (OT) strategy and roadmap for manufacturing and QC systems, ensuring alignment with I&T and business strategies.
- Advance paperless, recipe-driven, and data-integrated execution aligned to ISA-88/95 and Pharma 4.0 principles.
- Prioritize OT initiatives that enhance productivity, regulatory compliance, and manufacturing reliability.
- Communicate OT strategy, value realization, and roadmap progress to executive and site leadership.

**Enterprise OT Platform Lifecycle Ownership (DCS, MES, OT Data Systems, LIMS)**

- Provide lifecycle ownership for Enterprise GxP manufacturing and lab OT platforms including OSI Pi, LIMS, Enterprise MES, Edge, Configuration management, and other enterprise tools
- Provider governance and decisioning on Automation Systems (DCS/SCADA), MES, etc.
- Ensure platforms meet operational, compliance, and performance standards across global sites.
- Drive harmonization and modernization of Enterprise OT platforms and support the roadmap for site integrations.

**OT Governance, Compliance, and Architecture Leadership**

- Lead enterprise OT governance structures (Design Authority, Standards Council, etc.).
- Define global OT standards for configuration, recipes, data, and cybersecurity in alignment with I&T, C&Q/CSV, GAMP 5 and GxP requirements.
- Maintain validated, secure, and interoperable architectures between plant-level systems and enterprise data layers.
- Ensure OT environments adhere to 21 CFR Part 11, Annex 11, and digital validation best practices.

**OT Technology Deployment and Capital Project Oversight**

- Accountable for Tier 1 capital project delivery for manufacturing and QC digital platforms.
- Govern Tier 2/3 site projects to ensure adherence to global OT standards, validation, and cybersecurity requirements.
- Manage readiness, commissioning, and hypercare for OT systems introduced via T1 capital or digital programs.

**Organization / Center of Excellence Leadership and Team Development**

- Lead the global OT organization encompassing Lab Systems, Data Systems, Recipe Standards, and Innovation & Partner Enablement.
- Operate as the OT Center of Excellence (CoE), defining best practices, playbooks, and training for site automation and lab teams.
- Build global OT capabilities, talent pipelines, and competency frameworks.
- Manage OT budgets (opex/capex) and resource allocation to maximize enterprise value.
- Place a high priority on developing others through coaching, feedback, and developmental goals.
- Provide a positive and equitable working environment, emphasizing values such as Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

**Strategic OT Supplier and Platform Partnerships**

- Develop and manage strategic partnerships with automation, MES, historian, and lab system platform provider (e.g., Siemens, Jag, Starlims, Aveeva (OSI) Pi).
- Develop and manage strategic partnerships with integrator partners (Mescada, CapG, Avacone, Cognizant, etc.)
- Align supplier roadmaps to OT strategy and ensure service excellence, cost optimization, and innovation delivery.
- Establish joint governance with system integrators (SIs) and solution providers for lifecycle performance.
- Leverage partner ecosystems to advance automation, edge computing, and digital manufacturing maturity.

**Cross-Functional Collaboration and Operational Influence**

- Collaborate closely with I&T, Operations, Technical Operations, Quality, Validation, and Data Analytics while retaining ownership of the OT domain.
- Ensure seamless data and integration flows between OT systems, enterprise layers, and cloud solutions under validated control.
- Influence global and site leaders to adopt standardized OT processes, architectures, and governance.
- Represent OT in enterprise risk, cybersecurity, and digital transformation forums.

**Innovation and Emerging OT Technologies Enablement**

- Identify and pilot emerging OT and industrial digital technologies (AI/ML at the edge, digital twins, composable MES, Cloud, etc.).
- Translate pilots into validated, scalable solutions that enhance reliability, compliance, and improve business outcomes.
- Embed advanced analytics and process optimization into OT platforms.
- Foster a culture of innovation and continuous improvement across the OT ecosystem.

**Position Qualifications and Experience Requirements:**

Education

- Bachelor of Science in an Engineering, Automation, Computer Science or local equivalent.

Experience

- 15+ years’ work experience, with at least 5 years’ experience in execution systems, operational technology, IT and operations
- Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95)
- Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, DCS, MES, PAT, LIMS, Digital Methods, OSI Pi Data historian, etc.) in a regulated large-scale process-based manufacturing environment.
- Experience in running site-based shop floor and laboratory systems in a globally distributed footprint is highly desirable
- A proven track record of influencing the industry on operational technology via publications and presentations is strongly preferred.
- Experience building, managing, and deploying high performing, innovative and transformational process automation / execution systems across a global organization.
- Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills
- Ability to build, mentor and grow a high performing and cohesive team
- Experience in Process Excellence methodology is desirable but not required.
- Ability to work across a range of countries and cultures
- Demonstrated experience in managing leaders, employees, and cross-functional project teams.
- Strong project management skills and experience in engineering projects within biopharma manufacturing.
- Functional knowledge of cGMPs and manufacturing operations in FDA-regulated facilities.

Competencies

- Automation & Execution Systems Expertise
- Project Management
- Regulatory Compliance
- Team Leadership & Development
- Strategic Planning
- Continuous Improvement & Innovation
- Stakeholder Engagement
- Strategic innovation
- Delivering Enterprise Results and Value Orientation

**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>).

Pennsylvania

Automation Supplier Execution

The Automation Supplier Execution Lead is accountable for establishing and governing the local technical framework by which external partners deliver operational and capital OT services across GxP manufacturing systems, including but not limited to PCS, MES, PLC, Lab Instrument and SCADA platforms. This role will align with global governance for the technical aspects of supplier relationships, ensuring that master service agreements, quality plans, service agreements, maintenance agreements, partner KPIs, and platform lifecycle commitments are monitored at each site for each local partner. Additionally, this role is responsible for executing and managing the local shared services operating model for OT partners, including local adoptions of enterprise services management and embedded engineering services.

- Role that this position reports to: Site Automation Head
- Role/s that report to this position: This role is an individual contributor

**Responsibilities:**

1. **Local OT Partner Governance & Shared Service Model**

- Execute against the local framework for OT partners, including strategic platform providers, strategic suppliers and shared service delivery models.
- Define and monitor roles, responsibilities, and interfaces between partners, shared services, and internal teams to avoid overlap and gaps.
- Ensure partner governance practices (costings, reviews, escalations, approvals) are consistently monitored.
- Drive adherence in collaboration with DQ and CSV to GxP, safety, and regulatory expectations in all partner-delivered services and projects.

2. **Enterprise Services & Shared Services Structure**

- Monitor the global OT service catalog, SLAs/KPIs, and RACI for internal teams, shared services, and external partners.
- Coordinate with global and site stakeholders to ensure services are right-sized, sustainable, and cost-effective.
- Monitor service performance data and drive improvements in reliability, responsiveness, and quality of shared and partner-delivered services.

3. **Contracting, MSAs & Project Templates**

- Own and maintain local adoption master service agreements, quality plans, service agreements, and maintenance agreements for strategic OT partners and shared services.
- Execute project contracting templates for use across all OT platforms and project types.
- Partner with Above-site E&M, Legal, Procurement, and functional contract owners to ensure contracts clearly define scope, deliverables, compliance, and pricing structures.
- Periodically review and refresh contract terms to reflect evolving business needs, risk posture, and partner performance.

4. **Partner Project Delivery Management**

- Oversee partner project delivery quality for OT-related operational and capital projects, ensuring adherence to global standards, templates, and governance.
- Establish expectations for partner project governance, documentation, testing, and handover to operations for all partner-led projects.
- Capture and feed partner related project lessons learned into global standards, templates, and partner governance processes.

5. **Platform Lifecycle & Enterprise Alignment**

- Ensure partner and shared service agreements support the full lifecycle of OT platforms (introduction, expansion, upgrades, decommissioning).
- Align local partner responsibilities with platform roadmaps for PCS, MES, OSI PI, LIMS, and other OT enterprise applications.
- Coordinate with OT Architecture, I&T, and platform owners to confirm lifecycle activities are contractually defined, resourced, and scheduled.
- Track local execution of lifecycle activities and drive corrective actions when deviations from standards, timelines, or quality expectations occur.

6. **Performance Management & Strategic Relationship Leadership**

- Monitor local KPIs, scorecards, and review cadences for strategic OT partners and shared services.
- Lead periodic performance and business reviews with partners and shared service leaders to address issues, risks, and opportunities for improvement.
- Act as the primary escalation point for structural performance concerns or contractual disputes related to OT services.
- Foster long-term, collaborative relationships with strategic partners and shared service teams that promote innovation, efficiency, and reliability across the OT ecosystem.

**Education:**

- Bachelor of Science in an Engineering, Automation, Computer Science or local equivalent.

**Experience:**

- 10+ years’ work experience, with at least 5 years’ experience in execution systems, operational technology, IT and operations
- Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95)
- Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, DCS, MES, PAT, LIMS, Digital Methods, OSI Pi Data historian, etc.) in a regulated large-scale process-based manufacturing environment.
- Experience writing, executing, and monitoring automation contract deliverables
- Ability to work across a range of countries and cultures
- Strong project management skills and experience in engineering projects within biopharma manufacturing.
- Functional knowledge of cGMPs and manufacturing operations in regulated facilities.

**Competencies:**

- Automation & Execution Systems Expertise
- Project Management
- Regulatory Compliance
- Strategic Planning
- Stakeholder Engagement
- Strategic innovation
- Delivering Enterprise Results and Value Orientation

*The expected base salary range for this position at hiring is $138,000 - $164,000. 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>).

Illinois

Legend Biotech

Sr. Manager Engineering

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 **Sr. Manager Engineerin**g as part of the **Facilities and Engineering** team based in **Raritan, NJ.**

**Role Overview**

The Senior Manager, Engineering, is responsible for leading a multidisciplinary engineering organization supporting commercial CARVYKTI® cell therapy manufacturing operations. This role provides strategic and technical leadership for the lifecycle management of manufacturing equipment and systems, process optimization initiatives, manufacturing troubleshooting, cost of goods (COGs) reduction programs, and management of a Facilities Investigation Team responsible for non-conformance investigations.

The successful candidate will lead a team of engineers and investigators that ensure manufacturing equipment reliability, operational excellence, regulatory compliance, and continuous improvement across the cell therapy manufacturing process. This position serves as a key partner to Manufacturing, Quality, Validation, Maintenance, MSAT, Supply Chain, and Regulatory functions to ensure uninterrupted production and continuous advancement of manufacturing capabilities.

**Key Responsibilities**

- Lead, develop, and mentor a team of engineering professionals responsible for cell therapy manufacturing operations and equipment support.
- Establish team goals, performance objectives, and development plans aligned with site and business priorities.
- Foster a culture of safety, accountability, technical excellence, innovation, and continuous improvement.
- Build organizational capabilities to support commercial growth, technology transfer activities, and future manufacturing expansion.
- Own the lifecycle management strategy for cell therapy manufacturing equipment, utilities, and process systems.
- Ensure equipment reliability, availability, and compliance throughout the asset lifecycle.
- Oversee equipment qualification, change management, obsolescence planning, capacity planning, and technology upgrades.
- Partner with Validation, Maintenance, and Quality organizations to maintain equipment in a validated state and inspection readiness.
- Drive long-term asset management strategies to support manufacturing continuity and operational resilience.
- Provide engineering leadership for troubleshooting complex manufacturing equipment and process performance issues.
- Lead root cause analysis efforts for equipment-related deviations, process interruptions, and manufacturing challenges.
- Identify and implement process optimization opportunities to improve equipment utilization, throughput, yield, reliability, and operational efficiency.
- Utilize data analytics and performance metrics to drive evidence-based decision making and identify improvement opportunities.
- Support implementation of new technologies, automation solutions, and digital manufacturing initiatives.
- Develop and execute engineering strategies to reduce manufacturing costs while maintaining product quality, compliance, and patient supply.
- Lead cross-functional continuous improvement initiatives focused on process efficiency, cycle time reduction, yield improvement, labor optimization, and waste reduction.
- Identify and execute capital and operational efficiency projects with measurable business impact.
- Establish and monitor operational metrics to quantify project benefits and support business case development.
- Lead the Facilities Investigation Team responsible for supporting manufacturing non-conformance, deviation, and investigation activities.
- Ensure timely, thorough, and scientifically sound investigations utilizing structured root cause analysis methodologies.
- Drive effectiveness of corrective and preventive action (CAPA) programs by ensuring sustainable solutions are implemented and monitored.
- Partner with Manufacturing, Quality, MSAT, and Regulatory teams to assess product and process impact of manufacturing events.
- Ensure investigation quality, compliance, and closure timelines meet site and regulatory requirements.
- Identify recurring event trends and proactively implement preventive actions to improve manufacturing performance.
- Ensure all engineering activities comply with cGMP, FDA, EMA, and applicable global regulatory requirements.
- Support internal audits, regulatory inspections, and quality system initiatives.
- Maintain inspection readiness within areas of responsibility.
- Participate in risk assessments, change control reviews, and quality management processes.
- Serve as a key technical leader within the manufacturing organization.
- Collaborate with Manufacturing, MSAT, Quality, Validation, Facilities, Supply Chain, and Global Engineering organizations.
- Support new product introductions, process changes, technology transfers, and facility expansion initiatives.
- Provide technical recommendations and presentations to site leadership and senior management.

**Requirements**

- Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, Electrical, or related discipline) required.
- Master's degree or MBA preferred.
- 10+ years of engineering, manufacturing, technical operations, or process support experience within the pharmaceutical, biotechnology, biologics, cell therapy, or related regulated industry.
- 5+ years of people leadership experience managing technical or engineering teams.
- Experience supporting cGMP manufacturing operations required.
- Experience leading complex investigations, root cause analysis, and CAPA implementation preferred.
- Experience supporting commercial biologics, advanced therapies, or cell therapy manufacturing highly preferred.
- Demonstrated success leading continuous improvement and cost reduction initiatives.
- Equipment lifecycle management and asset reliability programs.
- Cell therapy, biologics, or aseptic manufacturing processes.
- Deviation management, non-conformance investigations, and quality systems.
- Root cause analysis methodologies (e.g., Fishbone, 5 Why, Fault Tree Analysis).
- Process optimization and operational excellence methodologies.
- Change control, validation, and risk management principles.
- Regulatory requirements including FDA, EMA, ICH, and cGMP standards.

\#Li-BZ1

\#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):

$146,410 - $192,164 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/>).

New Jersey

Investigator I/II

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 **Investigator I/II** as part of the **Technical Operations** team based in **Raritan, NJ.**

**Role Overview**

Investigator II independently leads and manages moderate- to high-complexity quality investigations related to manufacturing, engineering, facilities, equipment, and validation systems. This role assesses product quality, patient impact, and regulatory significance using a science- and risk-based approach; performs comprehensive root cause analyses; develops robust investigation reports, CAPAs, and effectiveness strategies; and ensures compliance with site procedures, regulatory requirements, and data integrity standards. Investigator II collaborates cross-functionally with subject matter experts and business partners to resolve complex quality events, support timely product disposition decisions, and drive continuous improvement initiatives.

**Key Responsibilities**

- Independently lead end-to-end investigations related to manufacturing, facilities, engineering, equipment, validation, and other cross-functional quality events.
- Collect, review, and evaluate supporting investigation data, including manufacturing records, equipment logs, environmental monitoring data, maintenance records, validation documentation, and historical quality events.
- Conduct investigations related to facility and environmental monitoring excursions.
- Demonstrate the ability to prioritize and dynamically adjust workload based on business needs, product impact, and organizational priorities.
- Perform comprehensive risk and impact assessments related to product quality, patient safety, data integrity, and regulatory compliance.
- Timely Prioritize investigation activities and timelines to support patient batch disposition and release decisions using a robust risk-based approach and impact assessment, leveraging the required SMEs.
- Conduct detailed root cause analyses using various structured methodologies.
- Develop and own CAPA investigations; ensure timely closure and proper effectiveness checks.
- Drive and owns investigation meetings, cross-functional alignments and support resolution of complex quality events.
- Rapidly learn and develop a strong understanding of new manufacturing, engineering, validation, and facility processes to support effective and efficient investigations.
- Collaborate closely with SMEs, Quality leads, and cross-functional stakeholders to ensure investigations are thorough, scientifically sound, and inspection-ready.
- Support internal audits and regulatory inspections, including presenting investigation, findings, and conclusions to auditors and inspectors.
- Ensure all investigations are completed in accordance with established quality standards, regulatory requirements, and defined timelines.
- Contribute to continuous improvement initiatives related to investigation processes, documentation practices, systems, and quality tools.
- Demonstrate strong analytical thinking, critical reasoning, and problem-solving skills when evaluating complex quality events.
- Analyze investigation and deviation trends to identify recurring issues, systemic risks, and opportunities for proactive process improvements.
- Author clear, concise, and scientifically justified investigation reports suitable for regulatory review and inspection scrutiny.
- Provide guidance and technical support to junior investigators and cross-functional teams on investigation methodologies and root cause analysis techniques
- Recognize and escalate critical quality issues appropriately while ensuring timely communication with stakeholders and leadership.
- Utilize electronic quality management systems (eQMS) to manage investigations, CAPAs, effectiveness checks, and associated quality records.

**Requirements**

- BS/BA in engineering, science, or related field.
- 4-6 years of cGMP experience within biotechnology, biopharmaceutical, pharmaceutical, or other regulated industries, and/or 2-4 years of quality investigation experience. Experience in
  engineering, facilities, equipment, validation, or quality systems is preferred. A combination of relevant industry, technical, and investigation experience will be considered. Demonstrated ability to independently manage multiple concurrent investigations while consistently meeting quality and timeliness expectations.
- Demonstrated proficiency in conducting moderate- to high-complexity investigations, performing risk assessments, identifying root causes, and developing effective corrective and preventive actions (CAPAs).
- Experience conducting product impact assessments and applying risk management principles in support of quality and disposition decisions.
- Experience reviewing and interpreting manufacturing, engineering, maintenance, calibration, environmental monitoring, and validation records to support investigation activities.
- Excellent technical writing and documentation skills, with the ability to independently author clear, concise, scientifically sound, and inspection-ready investigation reports.
- Working knowledge of electronic Quality Management Systems (eQMS)
- Demonstrated ability to effectively collaborate and influence crossfunctional teams in resolving complex quality events.
- Strong Ability to present investigation outcomes and respond to internal audit and regulatory inspection inquiries with minimal oversight.
- Technical knowledge of biologics, cell therapy, gene therapy, or pharmaceutical manufacturing processes.
- Proficiency in science- and risk-based decision-making and structured root cause analysis methodologies (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
- Working knowledge of cGMP regulations, quality systems, and data integrity principles.
- Experience supporting regulatory inspections, audits, and health authority inquiries.
- Strong technical writing, communication, and presentation skills.
- Ability to independently manage multiple moderate- to high-complexity investigations.
- Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS).

This is a leveled position. Please see the salary ranges for each level below:

Investigator I : $72,791 - $95,540

Investigator II: $78,251 - $102,705

\#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):

$72,791 - $102,705 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/>).

Senior Engineer / Principal Engineer, Vector Downstream

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 Senior Engineer / Principal Engineer, Vector Downstream as part of the **Technical Development** team based in **Somerset, NJ.**

**Role Overview**

The Senior Engineer / Principal Engineer, Vector Downstream will be responsible for designing, optimizing, and scaling purification processes for lentiviral vectors (LVV) within our innovative pipeline. This role focuses on delivering high-quality vector products to support LVV generation and other advanced cell therapy programs. The successful candidate will drive scientific excellence in scaling automation capabilities from concept to operation, integrating analytics and modeling into downstream workflows, and translating microscale insights into robust, scalable processes for GMP manufacturing. The level and scope of responsibility will be determined based on the candidate's experience, technical expertise, and demonstrated impact.

**Key Responsibilities**

- Build state-of-the-art mechanistic and hybrid models that directly influence the development of LVV downstream processing, building operational efficiency through model-first and AI-enabled development strategies.
- Apply core engineering concepts including mass transfer, fluid mechanics, and thermodynamics to build robust in silico process models.
- Perform data analytics using ML algorithms for modeling and clustering to generate process insights.
- Working closely with the team to implement development and optimization of downstream processes including clarification (depth filtration, centrifugation), chromatography (AEX, SEC, HIC), and Tangential Flow Filtration (TFF).
- Lead or support the translation of bench-scale processes to GMP manufacturing, ensuring seamless technology transfer and providing troubleshooting support during clinical production runs.
- Design/Implement different Advanced Process Control (APC) strategies (e.g., MPC, State Estimators) to optimize process performance.
- Communicate potential issues and delays along with solutions and mitigation approaches.
- In collaboration with senior leaders and cross-functional partners, identify project acceleration opportunities.
- Leverage advanced science and technology to maximize vector recovery, purity, and potency.
- Provide technical guidance and collaborate with scientists and cross-functional team members in the execution of project-specific activities.
- Author and serve as a primary reviewer for technical documents, including development reports, SOPs, and CMC sections for regulatory submissions.
- Work closely with Upstream Process Development and Analytical Development teams to ensure integrated process outcomes.
- Tech transfer process to/from other Legend sites or CDMOs.
- Proactively identify technical challenges and drive effective solutions and mitigation strategies.
- Ensure compliance with regulatory requirements.

**Requirements**

- Advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, or a related field.
- 6+ years (PhD) or 8+ years (MS) of experience in process development or manufacturing within a biotech or pharmaceutical setting. Candidates with additional experience and demonstrated technical leadership may be considered at the Principal Engineer level.
- Strong engineering knowledge of bioprocess modeling/simulation and the interaction of biomolecules, materials, and machinery.
- Experience with modeling software and programming languages such as Python and/or MATLAB preferred.
- Strong technical experience in purification, chromatography, and TFF, with demonstrated expertise in downstream process development.
- Understanding of GMP manufacturing requirements and CMC strategies for clinical-stage product development.
- Experience with lentiviral vector technologies preferred. Candidates with relevant viral vector, biologics, gene therapy, or advanced therapy process development experience will also be considered.
- Strong communication, collaboration, leadership, and problem-solving skills with the ability to influence cross-functional teams and navigate complex development timelines.
- Creative and strategic thinking.
- Strong troubleshooting skills.
- Preferred experience in developing vector processes tailored for in vivo CAR-T generation and systemic delivery.
- Preferred experience in large-scale (\>50L) purification processes.
- Language(s): English. Mandarin is a plus.

\#Li-JR1

\#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):

$146,410 - $192,164 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/>).

Sr. MES Engineer

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 **Sr. MES Engineer** as part of the **Manufacturing & Supply** team based in **Raritan, NJ.**

**Role Overview**

The Senior MES Engineer will be a driving member of the Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for independently driving and performing EBR development and administration at the Raritan site to support production processing while managing interactions with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will be held accountable for on time delivery of electronic batch record (EBR) updates while suggesting, evaluating and implementing system improvements, drive applicable process and facility updates, and support qualification activities associated with MES (PAS-X).

**Key Responsibilities**

- Drive eBR development, modeling, and on time deployment in MES
- Accountable for coordinate with other departments to gather user requirements, gauge effort, and deliver robust, right first time EBR
- Participate in and deliver design testing, release planning, and demos with Ensure successful roll-out of MES update with minimal corrections/ revision based on end user feedback.
- Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring MES
- Lead the coordination of MES updates with other Supply Chain Systems (ERP, eLIMs, ).
- Drive, coordinate and execute right first time MES validation activities according to the Software Development Lifecycle (e.g. commissioning test Plans (CTP), Installation/Operational Qualification (IOQ).
- Responsible for defining standardization and update documentation (e.g. SOPs, Wis, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures.
- Act as a Site MES SME to support Quality Investigations, Corrections, and QMS
- Build the Site Readiness of MES for FDA and/or Other Regulatory Audits/
- This individual is responsible for the training of Manufacturing Excellence and Operations on MES utilization and ensuring that Manufacturing Excellence and Operations properly assesses updates and impact.
- Key Relationships: establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.

**Requirements**

- A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.
- A minimum of 6-8 years of relevant experience is required. Demonstrated experience translating business needs to system requirements. Cell/Gene Therapy cGMP manufacturing and project planning experience preferred.
- Provide technical expertise of Change Control process as well as oversight of the MES team to ensure smooth implementation of system enhancement activities.
- Accurately and reliably gauge task effort and plan work to meet project timelines
- Work closely with the development and MS&T organization to ensure translation of changes from concept to implementation, building long term implementation and support plans.
- Work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Provide technical recommendation and limitations associated with MES functionality in the evaluation of potential process changes for effectiveness, value, risk, and priority.
- Drive the implementation of MES enhancements that would provide reduction in COGs, and increase throughput, capacity, and quality compliance.
- Work cross-functionally across Technical Operations and interface with IT to drive the design and implementation of new system updates for cell therapy development and manufacturing.
- When necessary, support studies related to process improvement and implementation of new manufacturing execution system technologies.
- An ability to build strong partnerships and effectively integrate with cross functional collaborators to drive projects/programs forward in a matrixed environment.
- Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and
- Clear and succinct verbal and written communication skills.

\#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):

$127,313 - $167,099 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/>).

Manufacturing Lead Operator, Aseptic Process

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 **Manufacturing Lead Operator, Aseptic Process** as part of the **Manufacturing & Operations** team based in **Raritan, NJ.**

**Role Overview**

CAR-T products and processes are a novel cell therapy, and thus are well supported by a degree in engineering or a related field where not only are valuable scientific and technical skills learned, but also the ability to connect ideas and analyze complex problems. This role will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an assigned production shift schedule.

**Key Responsibilities**

- This individual establishes effective time management skills and prioritization of various job requirements, supported by a degree in engineering or related field to better analyze and execute effective decision during critical times for positive outcomes.
- To offer support in development of CAR-T manufacturing processes, this individual requires an understanding of the underlying technical requirements of the process and product must have, where complex risk analyses and change management techniques are utilized to establish a high quality and safe drug product through periods of improvement.
- This individual with strong scientific and technical background, will support the development of manufacturing processes, and will work with technical support and engineering personnel to drive continuous improvements and implement corrective and preventative actions within cell therapy Technical Operations.
- This individual will be responsible for general production floor oversight of Legend Biotech's BCMA CAR-T Cell Therapy Operations in both ISO 5 and ISO 7 environments, and support floor activities with extensive knowledge of CAR-T cell therapy processes, GMP quality systems and their regulatory requirements.
- This individual requires prior in-depth knowledge of lab sciences, cellular lab techniques, and data analysis to complete daily responsibilities and assess the impacts and consequences in relation to other process areas, without jeopardizing quality, accuracy and efficiency.
- This individual will perform process unit operations (i.e. cell culture, purification, aseptic processing, and cryopreservation) performed within specialized BSL2+ ISO 5 and ISO 7 cleanroom environments, according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.
- This individual will require critical thinking and troubleshooting skills to respond to patient specific product issues to ensure continuous flow of operations, while performing tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements within particular manufacturing processes.
- Establish key stakeholder relationships with internal and external stakeholders, as collaboration and understanding across functional stakeholders are essential to maintaining this dynamic, fast-paced environment, which is CAR-T manufacturing
- With a degree in engineering and related scientific or technical field, this individual must have the ability to interact with all levels within the organization through scientific and technical expertise
- Strong communicative skills and a broad technical understanding of complex systems are must haves, to build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross-functional and matrixed team to successful manufacture CAR-T product in a safe and high quality manner.

**Requirements**

- Bachelor’s degree in life science/engineering, or related field or equivalent experience required.
- A minimum of 2 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, maintenance, quality, testing, or engineering is required. Prior experience in an aseptic manufacturing environment is preferred.
- An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
- Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products.
- Ability to lift a minimum of 50 lbs and stand for a long period of time.
- Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records.
- Ability to handle human derived materials in BSL-2 cleanroom facility.
- Physical dexterity sufficient to use computers and documentation.
- Ability to accommodate shift work including evenings and weekends as required by the manufacturing process.
- Ability to accommodate unplanned overtime on little to no prior notice.
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals
  - Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.
  - Color Perception both eyes 5 slides out of 8.
- **AI Literacy:** Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use.

\#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):

$83,711 - $109,870 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/>).

Tris Pharma

Quality Engineer

**Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs**. We have \>150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

**Located in Monmouth Junction, New Jersey, Tris has an immediate opening for Quality Engineer**

**SUMMARY:**

Quality Engineer supports and assists the Quality Assurance (QA) function by merging product data evaluation under FDA 21 CFR 211.180(e) with technical engineering controls to ensure commercial products consistently meet safety, identity, strength, quality and purity standards. The incumbent leads the statistical trending, data collection and aggregation and drafting of Annual Product Quality Reviews /Annual Product Reviews (APQRs/APRs) to monitor product/process stability and make data-driven continuous improvement across various production processes in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.

**ESSENTIAL FUNCTIONS:**

- Maintains all appropriate Quality related documentation, as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs
- Leads the evaluation of annual product quality data to identify emerging quality risks, process variability, adverse trends and opportunities for continuous improvement; Utilizes statistical methods and quality risk management principles to transform manufacturing, laboratory and stability data into actionable business and compliance decisions; Collaborates with various departments, functions and appropriate Subject Matter Experts (SMEs) to submit all sub-reports in a timely, accurate and complaint manner
- Hosts APR risk assessment meeting, tracks attendance and takes appropriate actions on team recommendations
- Performs Advanced Trend Analysis for Intermediate, In-process, Finished Product and Stability batches: Evaluates critical quality attributes (CQAs) and critical process parameters (CPPs) using statistical methods; Verifies consistency of existing processes and identifies trends; Properly addresses and reports all negative trends
- Analyzes and interprets large datasets from Manufacturing, Packaging, Laboratory departments, complaints, deviations, Corrective Action Preventive Action (CAPAs), change controls and stability programs to identify statistically significant trends, process shifts and emerging quality risks including, but not limited to: analyzing Deviation and Rejection Profiles, trending manufacturing deviations, batch failures, yield losses and Out-of-Specification (OOS) laboratory findings (i.e., dissolution, uniformity, particle size), etc.
- Applies statistical methods including control charts, process capability analysis, regression analysis, Pareto analysis and trend modeling to evaluate process performance and product lifecycle health
- Evaluates cumulative impact of deviations, CAPAs, change controls, complaints, stability trends, analytical changes and validation activities on product quality throughout product lifecycle
- Recommends revalidation and determines the need for process revalidation or changes to registered specifications based on APQR/APR data and conclusion
- Drives Root Cause Investigations by partnering with QA Investigations, Production, Laboratory, and Technical Services teams to investigate deviations using appropriate tools (i.e., Fishbone, 5 Whys and Failure Mode and Effects Analysis (FMEA)); Mitigates specific product risks by addressing unique technical challenges to company dosage forms and its associated intermediates
- Monitors process capability and calculates and analyzes process indicators such as Process Capability Index (Cpk) and Process Capability Index (Ppk) to monitor process variability
- Maintains all appropriate Quality related documentation, as assigned, while assuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs pertaining to documentation and records management
- Participates in inspections, as needed and supports Regulatory audits by acting as SME for APQRs, trending data and process statistics during FDA and foreign health authority inspections; Assists in other areas of QA and may cross train across department, as needed
- Any other APR tasks assigned by Supervisor or Quality Senior Management

Requirements

**QUALIFICATIONS**

Minimum education and years of relevant work experience

Bachelors degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline and minimum 5 years in quality systems, process validation, product quality review or quality engineering in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility OR combination of education and related quality systems, process validation, product quality review or quality engineering in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility.

Special knowledge or skills needed and/or licenses or certificates **required**

- Deep understanding of FDA 21 CFR Part 210/211, ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10
- Familiarity with laboratory testing equipment such as automated dissolution testers, High Pressure Liquid Chromatography (HPLC), particle size analyzers and viscometers/rheometers, etc.
- Ability to translate statistical observations into quality risk assessments and business recommendations using risk management tools and structured decision-making methodologies
- Proficiency in statistical analysis platforms such as Minitab, JMP or SAS for process trending and control charting
- Demonstrated experience applying statistical methodologies including, but not limited to: Control charting, Process capability analysis, Trend analysis, Regression analysis, Hypothesis testing, Analysis of Variance (ANOVA), Sampling plans, Statistical interpretation of manufacturing and laboratory data, etc.
- Validation Knowledge: Strong foundational knowledge of Process Validation lifecycle stages (Stage 1, 2, and Stage 3 Continued Process Verification). Experience developing, monitoring, and interpreting Continued Process Verification (CPV) data and process performance indicators
- ASQ Certification: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
- Proficiency with Microsoft Office
- Excellent verbal and written communication and skills
- Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
- Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Excellent planning, organization and time management skills including the ability to support and prioritize stability program
- Fluent in English (verbal and written)
- Ability to identify and distinguish colors
- Ability and willingness to work additional hours as required by business needs

Special knowledge or skills needed and/or licenses or certificates **preferred**

- Experience working with various dosage manufacturing (oral solid or liquid dosages, delayed or extended release products, etc.)
- Lean Six Sigma: Green Belt or Black Belt certification
- Experience with data visualization and reporting tools such as Power BI, Tableau, JMP Live, Spotfire, or equivalent platforms

**Travel requirements**

- 0%

**Physical requirements**

- Office / Laboratory based position
- Ability to lift up to 30 lbs
- Ability to use Personal Protective Equipment (PPE)
- Ability to stand for extended periods

**Anticipated salary range**: $100k – $145k. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities,

GRAIL Inc

Senior Process Engineer - Compliance #4968

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

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

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

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

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

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

This position works full time onsite in Durham, NC.

**Responsibilities:**

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

**Required Qualifications:**

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

**Preferred Qualifications:**

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

**Physical Demands and Work Environment:**

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

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

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

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

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

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

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

North Carolina

AbbVie

Principal Data Engineer, AI Enablement

Company Description

**About AbbVie**

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

Job Description

The Principal Data Engineer, AI Enablement will design, develop, and maintain data solutions that drive the advancement and enablement of our AI and machine learning use cases. In this role, you will collaborate closely with data engineers, data scientists, architects, and business analysts to advance the core data capabilities, deliver projects, foster technological innovation, and promote continuous improvement.

**Responsibilities:**

- Collaborate with a cross-functional team of engineers, architects, data scientists, business system analysts and product owners to understand requirements and deliver fit-for-purpose solutions.
- Design, develop, and maintain scalable AI-ready data solutions for diverse data sets to support pharma value chain.
- Design, develop, and maintain solutions involving the integration of LLMs (such as GPT or Claude or similar technologies) for data mining, knowledge extraction, and automation of data-driven insights.
- Design, develop, and maintain solutions to operationalize machine learning models, including model deployment, monitoring, and lifecycle management.
- Capture and interpret user requirements into expressive data models that enable graph analytics, semantic reasoning, and GenAI integration.
- Research and recommend appropriate tools, frameworks, and platforms for graph databases, vector stores, and large language models integration including agent-based solutions.
- Provide technical leadership, act as a subject matter expert and advisor to partners on the feasibility and impact of emerging technologies in the AI data space.
- Ensure compliance with applicable AbbVie software development, lifecycle policies, and procedures.

Qualifications

**Required:**

- Bachelor's Degree with 8 years of experience; OR Master's Degree with 7 years of experience; OR PhD with 3 years of related work experience and a strong understanding of specified functional area.
- Must have experience with MLOps, LLM integration, Data Agents, Agentic Memory and Graph RAG systems, text mining, and unstructured data processing.
- Experience designing and building data pipelines, ETL/ELT processes, and data models.
- Proficiency with Python, SQL, and distributed data processing frameworks such as Spark.
- Experience with CI/CD practices, data quality controls, governance, and security considerations.

**Preferred:**

- Degree in Computer Science or related discipline preferred. Advanced degree preferred.
- Experience with Neo4j & Elasticsearch database technologies is preferred.
- AWS experience is preferred.

Additional Information

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

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

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

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

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

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

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

United States Pharmacopeia

Network Engineer

**Description**

**Who is USP?**

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

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

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

**Brief Job Overview**

The Network Engineer supports the organization's network infrastructure by assisting with routing and switching operations, troubleshooting network issues, and maintaining documentation. This role focuses on developing foundational networking skills while contributing to the stability, performance, and security of the enterprise network.

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

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

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

**The Network Engineer has the following responsibilities:**

- Assist in supporting network infrastructure, including basic break/fix tasks and routine installations.
- Troubleshoot and resolve entry-level network hardware and software issues under senior guidance.
- Monitor network activity to identify irregularities and escalating issues appropriately.
- Support network uptime and health monitoring to ensure availability of critical systems.
- Assist with IOS patch management tasks as directed.
- Help maintain network availability in alignment with Service Level Agreements.
- Participate in capacity and performance assessments to understand network growth needs.
- Provide input on network design improvements focused on routing and switching.
- Assist with coordination of vendors and service providers during project tasks.
- Create and maintain accurate network documentation following organizational SOPs.
- Research and recommend basic hardware or software updates to improve network performance.
- Support evaluation of new equipment for compatibility with existing systems.
- Participate in disaster recovery exercises and planning activities.
- Provide limited support for F5 load balancer tasks under supervision.
- Assist with Wi-Fi troubleshooting and basic wireless configuration tasks.
- Participate in on-call support and occasional off-hours maintenance/project work including Saturdays and Sundays.
- Work onsite during the workweek.
- Perform other related duties as needed.

**Who is USP Looking For?**

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

- Bachelor’s degree (or equivalent work experience) in Information Technology, Computer Science, Engineering, or a related discipline from an accredited institution.
- Proven experience with Cisco networking technologies, backed by an active CCNA certification.
- Three (3) years of experience in network support, administration, or related IT functions.
- Foundational knowledge of enterprise networking platforms, especially Cisco and/or Juniper.
- Strong interest and developing expertise in routing and switching technologies.
- Basic understanding of firewall concepts and administration.
- Knowledge of VLANs and network segmentation strategies.
- Familiarity with network security principles such as VPNs, IPSEC, 802.1x, and RADIUS.
- Exposure to F5 load balancers (basic understanding).
- Exposure to Wi-Fi technologies and wireless troubleshooting.
- Ability to use network monitoring tools and follow troubleshooting methodologies.
- Ability to monitor network usage and escalate potential issues.
- Collaborative mindset for working with application and infrastructure teams.
- Ability to learn emerging technologies quickly and independently.
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to work in a fast-paced IT environment and manage shifting priorities.
- Ability to work with colleagues from diverse backgrounds.

**Supervisory Responsibilities**

None, this is an individual contributor role.

**Benefits:**

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

**Compensation:**

Base Salary Range: USD  **$83,368.00 – $118,800.00** annually.

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

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

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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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

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

**Job Category** Information Technology

**Job Type** Full-Time

Maryland

Senior Director, PHAROS Program

**Description**

**Who is USP?**

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

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

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

**Brief Job Overview**

Lead the development of the future of pharmaceutical product screening and help ensure counterfeit, substandard, and poor-quality medicines do not enter the United States. USP’s PHAROS Program (Pharmaceutical Holistic Authentication, Reference Intelligence, and Outcome Screening) is the answer to ARPA=H’s FASTPaSS initiative to develop and deploy rapid, through-package screening for all drugs entering the United States at the border. USP has assembled a winning coalition of organizations that include MIT Research Laboratory for Electronics, UCLA Samueli School of Engineering, Physical Sciences, Inc., the Martinos Center, LookIn, Inc., InforMetrix, Commonwealth Center for Advanced Manufacturing, National Association of Boards of Pharmacy, and STAQ Pharma.

The **Senior Director, PHAROS Program** will lead USP’s multidisciplinary initiative integrating advanced sensing, AI/ML-enabled analytics, multimodal data fusion, reference science, and physical product development. The role has end-to-end accountability for program execution across USP and consortium partners, including technical integration, partner coordination, prototype development, field testing, risk management, and sponsor commitments.

The successful candidate will combine strong program leadership and physical product/system development experience with technical depth in either Technical Area 1 (TA1) - Rapid, through-package sensing - or Technical Area 2 (TA2) - AI/ML-driven quality decision engine. Expertise in both technical areas is not required but would be welcome.

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

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

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

**The Senior Director, PHAROS Program** **has the following responsibilities:**

- Lead integrated PHAROS execution, including scope, milestones, deliverables, resources, dependencies, risks, and sponsor commitments to ensure the ultimate program deliverable is realized – a field-deployable prototype that meets all program requirements by the end of 4.5 years.
- With the dedicated support from the GHMS Program Delivery Team, coordinate USP teams, technical leaders, and external consortium partners to deliver an integrated program outcome.
- Lead development of PHAROS as a hardware-software-data system, from requirements and architecture through prototype integration, verification, validation, and field testing.
- Drive iterative design-build-test cycles and progression toward a reliable, usable, field-deployable solution.
- Establish effective program governance, decision-making, risk management, performance reviews, and partner accountability.
- Make and facilitate cross-program technical and programmatic tradeoffs while preserving the scientific leadership of the Co-Principal Investigators.
- Contribute technical expertise from either TA1—such as analytical science, spectroscopy, NMR, sensing, instrumentation, or pharmaceutical science—or TA2—such as AI/ML, chemometrics, signal processing, multimodal fusion, or digital decision systems.
- Apply systems thinking to evaluate evidence, challenge assumptions, manage technical interfaces, and resolve integration issues.
- Leverage USP’s standards, reference science, Expert Committees, industry relationships, and sample-access capabilities to strengthen PHAROS development and validation.
- Represent PHAROS with ARPA-H, consortium partners, industry and healthcare stakeholders, and USP leadership.

**Who is USP Looking For?**

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

- Bachelor’s degree in relevant scientific, engineering, computing, or quantitative discipline, or an equivalent combination of education and experience.
- Minimum 12 years of relevant experience, including leadership of complex scientific, engineering, technology, or product-development programs.
- At least five years of accountable program, product, or technical leadership experience involving multiple workstreams, external partners, or matrixed teams.
- Experience in pharmaceutical science, analytical technologies, compendial science, or regulatory science.
- Technical depth in at least one PHAROS-relevant TA1 or TA2 discipline.
- Demonstrated ability to lead across organizational boundaries, make complex technical and programmatic tradeoffs, manage risk, and drive results.
- Strong executive, technical, written, and interpersonal communication skills.

**Additional Desired Preferences**

- Advanced degree in a relevant discipline.
- Demonstrated experience leading development or integration of a physical or digital-physical product/system, including prototype development, systems integration, verification/validation, and field or operational testing.
- Experience with advanced sensing/instrumentation, AI/ML, chemometrics, signal processing, or multimodal analytics.
- Experience with systems engineering, hardware/software integration, requirements management, human factors, or field-deployable technology.
- Experience leading multi-institutional industry, academic, government, healthcare, or nonprofit partnerships.
- Experience with federally sponsored advanced technology programs such as ARPA-H, DARPA, BARDA, FDA, or DoD.
- Experience transitioning prototypes toward operational products or sustained programs.

**Supervisory Responsibilities**

Provides direct and matrix leadership across PHAROS program resources, USP technical teams, TA1 and TA2 Co-PIs, consortium partner leads, and product-development/integration teams.

**Benefits**

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

**Compensation**

Base Salary Range: USD $206,201.00 – $291,947.00 annually.

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

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

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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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

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

**Job Category** Technical Programs

**Job Type** Full-Time

Connected Factory Engineer

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

Connected Factory is a program focused on the technical stewardship of key integration capabilities and their associated platforms across Manufacturing Operations at AbbVie. The Connected Factory Engineering team will be responsible for helping progress the technical roadmap of platforms, accelerating the maturity of integrations between critical components of AbbVie's manufacturing shopfloor, and advancing the availability of data for advanced use cases. This will include work with Ignition, OSI PI, Kepware, HighByte, AWS Cloud Services, and many other platforms. Data and Integration capabilities that our team will support include API's and their management, IT/OT convergence, MQTT and other real-time data streaming protocols, Unified Namespace management, data historization, and event-driven services.

**Responsibilities:**

- Analyze existing solutions and processes and identify areas for optimization.
- Gather requirements from business users and translate them into technical specifications.
- Design and engineer technical capabilities to meet business needs.
- Develop system documentation, including user/admin manuals, architecture drawings, and technical specifications.
- Build and execute test protocols to ensure solutions are functioning to specification.
- Author deployment instructions and implement them across various platforms supported by the team.
- Intake, troubleshoot, and resolve technical issues as they are reported or as alerts are received.
- Ensure that systems operate effectively, securely, and comply with relevant regulations.
- Collaborate with cross-functional teams to ensure that solutions are integrated and scalable.
- Stay up to date with emerging trends and technologies in the field.

Qualifications

**Required:**

- Bachelor’s degree in Computer Science, Information Systems, or related field plus 2 years of experience as a Developer, Systems Analyst/Admin, Engineer/Integrator, or similar role; or Master's degree with 0 experience.
- Experience working with Ignition, Kepware, OSI PI, HighByte, and/or AWS Cloud Services.
- Excellent analytical, communication and consultative skills and the ability to work efficiently with clients and other IT management and staff.
- High focus on deliverables and detail oriented.
- Must exhibit exceptional teamwork skills.
- Demonstrate high proficiency across a wide range of technologies and platforms related to software design and development, programming languages, data integration, data warehousing, data analysis and visualization tools, data storage, network connectivity, and virtualization/cloud environments.

**Preferred:**

- Experience with Artificial Intelligence, Large Language Models, and their capabilities
- Experience in pharma, healthcare or regulated industry

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>)

Frederick National Laboratory for Cancer Research

Business Process Specialist IV

**Business Process Specialist IV**

Job ID: req4714

Employee Type: exempt full-time

Division: Facilities, Maintenance & Engineering

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

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

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

**PROGRAM DESCRIPTION**

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

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

**KEY ROLES/RESPONSIBILITES**

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

**BASIC QUALIFICATIONS**

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

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

**PREFERRED QUALIFICATIONS**

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

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

**Commitment to Non-Discrimination**

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

**Pay and Benefits**

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

98,200.00 - 144,600.00 USD

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

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

Lead Data Engineer

**Description**

**Who is USP?**

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that **Equity = Excellence** manifests in our core value of **Passion for Quality** through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

**Brief Job Overview**

The Digital product engineering team at USP is seeking a Data Engineer with expertise in building robust data pipelines, managing large-scale data infrastructure, and enabling advanced analytics capabilities. This role is critical to supporting projects that align with our mission to protect patient safety and improve the health of people around the world. We are looking for a professional who understands the value of clean, accessible, and well-organized data, and who enjoys designing systems that empower data scientists, analysts, and business stakeholders to derive actionable insights. The ideal candidate will be passionate about data architecture, cloud technologies, and scalable engineering solutions that drive innovation and impact.

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

- Design and implement scalable data collection, storage, and processing pipelines to support enterprise-wide data needs.
- Implement and maintain data governance frameworks and data quality checks within data pipelines to ensure compliance and reliability.
- Build and optimize data models and data marts to support self-service analytics and reporting tools such as Tableau, Looker, and Power BI
- Partner with data scientists to operationalize models by integrating them into production-grade pipelines, ensuring scalability, performance, and maintainability.
- Collaborate with cross-functional stakeholders (business, product, analytics, and engineering teams) to translate business requirements into scalable data solutions and prioritize data initiatives.
- Provide technical leadership and architectural guidance for data platform design, ensuring alignment with enterprise standards and long-term data strategy.
- Lead design reviews, code reviews, and data architecture discussions to ensure best practices, reusability, and high-quality deliverables.
- Collaborate with platform, DevOps, and security teams to ensure secure, cost-effective, and scalable data infrastructure.
- Influence data roadmap and strategy by identifying opportunities for data platform enhancement, automation, and cost optimization.

**Who USP is Looking For?**

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

Education

Bachelor’s degree in relevant field (e.g. Engineering, Analytics or Data Science, Computer Science, Statistics) or equivalent experience.

Experience

- 7+ years of experience in big data technologies such as Python, PySpark, and SQL for processing structured, semi-structured, and unstructured data.
- Strong experience with AWS data services including Redshift, S3, Glue, Lambda, EventBridge, Postgres, Neo4j (Azure/GCP equivalents such as ADLS, Synapse, ADF acceptable).
- Experience in building batch, micro-batch, and streaming pipelines (real-time / near real-time) using Lambda/Kappa architectures.
- Hands-on expertise in designing and delivering enterprise-scale data platforms, including data lakehouse, data warehouse, data lake, and data marts.
- Strong understanding and hands-on implementation of data modeling techniques including - Data Vault 2.0, Dimensional Modeling, Knowledge Graphs, One Big Table (OBT) approaches (Certification in at least one area preferred)
- Experience with medallion architecture and metadata-driven data pipeline frameworks.
- Strong expertise in data governance frameworks, including- Data discovery, Data quality, Data security, Hands-on experience with DQ tools such as Great Expectations, Pydantic, etc.
- Strong SQL and programming skills for data transformation, modeling, and analysis.
- Hands-on experience in building and maintaining complex ETL/ELT pipelines and managing day-to-day data operations.
- Experience with workflow orchestration tools such as Airflow (2+ years or equivalent).
- Knowledge of streaming/event-driven architectures and modern data processing patterns.
- Good understanding of dashboarding and visualization techniques with tools like Tableau, Power BI, or equivalent.
- Experience with Agile (SAFe) methodologies, CI/CD pipelines, and modern deployment practices for data platforms.
- Exposure to AI/ML concepts, with familiarity in Generative AI patterns (e.g., RAG, chunking techniques) as an added advantage.

**Additional Desired Preferences**

- Experience with scientific chemistry nomenclature or prior work experience in life sciences, chemistry, or hard sciences or degree in sciences
- Experience with pharmaceutical datasets and nomenclature
- Experience in developing Machine learning & Deep learning models; Familiarity with **MLOps** and deploying ML models in production environments.
- Ability to explain complex technical issues to a non-technical audience

**Supervisory Responsibilities:**

No

**Benefits**

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

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

**Job Category** Information Technology

**Job Type** Full-Time

Other Non-US

Nurix Therapeutics

Principal Engineer, Pharmaceutical Development

**Principal Engineer, Pharmaceutical Development Engineering**

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

**Position Description**

**The Opportunity**

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

**What You’ll Bring**

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

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

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

**Location:** Onsite – Brisbane, CA

**Fit with Nurix Culture and Values**

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

**About Nurix Therapeutics**

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

California

Lead, Value Stream

Company Description

**About AbbVie**

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

Job Description

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

Responsibilities

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

Qualifications

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

\#LI-CD3

Additional Information

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

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

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

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

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

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

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

Senior Software Engineer, Digital Products (Full Stack Developer)

**Description**

**Who is USP?**

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

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

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

**Brief Job Overview**

The Digital & Innovation group at USP is seeking a Senior Software Engineer for our digital products development teams.

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

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

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

The **Senior Software Engineer** has the following responsibilities:

- Design and build scalable applications using React, Node.js, and Java Spring Boot.
- Explore and integrate AI-driven solutions to improve digital products and workflows.

**Who is USP Looking For?**

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

**Education**

- Bachelor’s or Master’s degree in Computer Science, Engineering, or related field.

**Experience**

- 5–7 years of experience in software development with a focus on cloud computing and modern web technologies.

**Technology Stack**

**Frontend**

- Strong expertise in **js** (Preferred) or any other equivalent

**Backend**

- Experience with **js** and **Java Spring Boot** (Preferred) or any other equivalent
- Hands-on knowledge of **microservices architecture**

**Database**

- Relational databases: **MySQL, PostgreSQL (Preferred) or any equivalent**
- In‑memory data store: **Redis , Memcached or any other equivalent**
- Experience with **GraphQL clients** (Apollo Client)
- Familiarity with **SQLite DB Browser** for local database inspection

**Cloud & DevOps**

- Solid understanding of Cloud technologies with preferred technology being AWS and corresponding services like EC2, S3, IAM, Lambda, API Gateway
- Experience with **Docker** for containerization and application deployment
- Exposure to **CI/CD pipelines** and **automated testing** practices

**Additional Desired Preferences**

- Strong appetite for learning and applying **AI/ML technologies** in real-world use cases
- Experience working with engineering teams using **JIRA / Confluence**
- Familiar with **AI‑assisted design & prototyping tools** (Figma Make, Claude, v0)
- **Solution‑oriented** problem‑solver with strong organizational and multitasking skills
- Exposure to **regulated industries** like Pharma is a plus

**Supervisory Responsibilities**

None, this is an individual contributor role.

**Benefits**

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

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

**Job Category** Information Technology

**Job Type** Full-Time

Novo Nordisk

Process Engineering Technician- Nights

**About the Department**

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

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

What we offer you:

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

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

**The Position**

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

**Relationships**

Reports to Manager/Senior Manager.

**Essential Functions**

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

**Physical Requirements**

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

**Qualifications**

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

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

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

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

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