Position Summary
We are seeking a Senior Process Validation Engineer / Scientist to support late-stage CMC activities in preparation for a Biologics License Application (BLA) filing for an allogeneic cell therapy program. Working closely with cross-functional teams and under the guidance of senior CMC leadership, this individual will contribute to the execution of process performance qualification (PPQ) campaigns, continued process verification (CPV), and the authorship of key regulatory deliverables. The ideal candidate brings 7–10 years of biopharmaceutical experience, including direct involvement in BLA-stage validation activities.
Key Responsibilities
Process Validation Execution
- Support the design and execution of PPQ protocols and reports for drug substance and drug product in alignment with FDA guidance (2011 Process Validation Guidance, ICH Q8/Q9/Q10) and BLA timelines.
- Contribute to the development and implementation of the continued process verification (CPV) program, including parameter selection and statistical monitoring.
- Author and review process validation documentation including protocols, reports, and summary sections for regulatory submissions.
- Execute and document risk assessments (FMEA) to support validation approaches and justify process control decisions.
Ancillary and Supporting Duties
- Coordinate and execute supporting validation studies including extractables & leachables (E&L), container closure integrity testing (CCIT), shipping validation, and hold time studies.
- Support material criticality assessments and contribute to CQA/CPP justifications for BLA submission packages.
- Participate in contamination control strategy (CCS) assessments at CDMO sites.
Regulatory and CMC Documentation
- Author CMC sections related to process validation for BLA submissions (e.g., Module 3.2.S, 3.2.P) under senior review.
- Support responses to FDA information requests and contribute to technical justifications for process-related queries.
- Assist with IND amendments and ensure validation documentation remains aligned with the approved control strategy.
Data Analysis and Monitoring
- Analyze manufacturing process data for variability, trends, and statistical process control (SPC) signals using tools such as JMP or Minitab.
- Calculate and interpret process capability metrics (Cpk, Ppk) to inform control strategy and BLA narratives.
- Identify out-of-trend data and support root cause investigations and CAPA efforts as needed.
Cross Functional Collaboration
- Work closely with Process Development, Analytical Development, QA, QC, Regulatory Affairs, and CDMO partners to ensure integrated validation readiness.
- Contribute to cross-functional readiness reviews and help track validation milestones against BLA filing commitments.
Qualifications
Education and Experience
- B.S. in Biology, Bioengineering, Chemical Engineering, or a related discipline with 9–10 years of biopharmaceutical industry experience; or M.S. with 7–8 years; or Ph.D. with 4–5 years.
- Minimum 3 years in MS&T, Process Development, or GMP manufacturing with hands-on process validation responsibilities.
- Prior involvement in a BLA or IND/NDA submission cycle – required; direct experience authoring CMC sections strongly preferred.
- Experience in cell therapy manufacturing (allogeneic or autologous); familiarity with GMP cell culture, fill/finish, or cryopreservation a plus.
Technical Skills
- Working knowledge of FDA and ICH regulatory guidance for process validation and CMC documentation (ICH Q8/Q9/Q10).
- Hands-on experience executing PPQ campaigns and managing associated deliverables (protocols, reports, deviations).
- Proficiency in statistical process control and data analysis; experience with JMP, Minitab, or equivalent tools.
- Familiarity with aseptic processing requirements and contamination control for cell therapy or biologics manufacturing.
- Experience with risk-based approaches including FMEA and process risk ranking.
Competencies
- Strong technical writing skills with the ability to produce clear, well-organized regulatory documents.
- Organized and detail-oriented; able to manage multiple deliverables under BLA-driven timelines.
- Effective communicator and team player in a cross-functional, fast-paced biotech environment.
This is an opportunity to contribute meaningfully to a late-stage cell therapy program at a critical juncture on the path to commercialization. If you are a driven validation professional looking to deepen your regulatory and BLA experience, we welcome your application.
