Associate Manager, New Product Development, Quality Assurance, Contractor

Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases (www.celularity.com).  Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ. 

As an Associate Manager, New Product Development Contractor within QA, you will provide quality guidance and support all new research and development activities and associated R&D manufacturing processes, including PD/CMC activities. The candidate will serve as a key player in establishing and maintaining quality systems associated with product development conducted under GMP, including the production, and testing of R&D materials.  Experience with creation, review and approval of technical transfer documents, standard operating procedures, test methods, batch records and other GMP documentation are required.  Experience with medical device product development and testing is preferred. This candidate will be expected to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory Affairs and Manufacturing. 

1. Partners as Quality stakeholder for product research, development, process development projects ranging from cellular therapy and bioproducts targeting oncology, infectious diseases and degenerative diseases.
2. Ensures high-quality products are developed and launched in accordance to governing regulations, standards, best practices and processes.
3. Prepares, reviews and QC checks all Quality deliverables supporting research and development relating to products, including regulatory submissions (e.g., IND, BLA, 510(k), medical devices, 1271, RFD, amendments).
4. Drives key quality requirements (e.g. Design for Test, Design for Reliability, Quality by Design, critical process capabilities, etc.) in new product introduction and technical transfer.
5. Participates, supports and represents the quality team in research and development activities including design reviews and milestones/stage gates.
6. Reviews and approves product design documentation and technical transfer package to ensure quality compliance.
7. Actively participates and/or leads New Product Introduction (NPI) audits/assessments to ensure project deliverables adhere to governing processes and follow-up on remediation efforts as required.
8. Actively participates and assists stakeholders with Risk Analysis to include Risk Assessments, DFMEA/PFMEA’s, etc.
9. Assists in the planning, summary, approval and execution of verification and validation activities to ensure adequate coverage for new products and sustaining design changes
10. Reviews and reports quality data/metrics/KPIs to identify high priority issues as input into next generation products based on lessons learned.
11. Identifies, implements and executes input/suggestions for creating, revising and/or continual improvement of products, procedures and processes relating to research and development quality, especially scalable and risk-based processes.
12. Actively supports, interfaces and participates in technical transfer of new products to/from clinical readiness and commercialization.
13. Laisse with Clinical and Manufacturing QA to transition quality knowledge and oversight with new products relating to support Clinical Trial manufacturing, manufacturing operations, logistics/shipping and commercialization.

• Bachelor's degree in a Life Science required.
• Minimum of 7+ years of working quality experience within a GXP regulated field or function.
• Minimum 3+ years of working experience years of experience with design quality, technical transfer, new product introduction, R&D/PD support.
• Knowledgeable with FDA regulatory activities/processes.
• Experience with quality tools and methods required (e.g., root cause analysis, FMEAs, submissions, etc.).
• Proficient in developing strategies, policies, procedures where they may not have existed before and sustain.
• Project management skills strongly desired; ability to be involved in multiple high-priority projects with overlapping timelines required.
• Microbiology experience a plus.
• Exceptional attention to detail with high degree of focus.
• Able to follow instructions and procedures, both written and verbal.
• Identification and vendor interaction with CMO and new materials.
• Able to perform with minimal supervision and comfortable making decisions.
• Able to communicate results and issues effectively, both written and orally.
• Able to successfully motivate compliance among staff; team attitude.
• Comfortable in a small, dynamic company environment; perform and contribute in a team environment.
• Knowledge/experience with electronic quality systems and enterprise resource planning systems preferred (e.g., Veeva, ComplianceWire, LIMS, EtQ, TrackWise, Agile, SAP, Great Plains, StemLab, Salesforce, EDMS, LMS, ERP, SAS) preferred.
• CQA, CQE, CSQE, or RAC certification preferred.
• Excellent analytical decision making and problem-solving skills.
• Ability to partner with individuals to build strong cross-functional relationships.

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