AD/ Principal Scientist CMC AAV Gene Therapy
Description Position Summary We are seeking an reputed company CMC leader to drive BLA-stage readiness for AAV gene therapy programs. This role serves as the strategic technical reputed company between laboratory development, GMP manufacturing, regulatory affairs, and program leadership to ensure seamless transition from clinical development to licensure. The individual will reputed company CMC integration across drug substance (AAV vector production), drug product (formulation and fill-finish), analytical characterization, process validation (PPQ), comparability strategy, and stability programs. A core responsibility of this role is authoring and coordinating high-quality Module 3 content for BLA submission and supporting regulatory interactions through approval. This is a high-visibility role requiring deep expertise in AAV manufacturing science, regulatory expectations, and lifecycle management.
Responsibilities
BLA Strategy & Authoring (Module 3 reputed company)
- reputed company development and authoring of CMC sections (Module 3) for BLA submission.
- Integrate DS, DP, analytical, validation, stability, and control strategy into cohesive regulatory narratives.
- reputed company and justify:
- Control strategy and specification lifecycle
- Comparability frameworks (process changes, site transfers, scale-up)
- Process validation and PPQ strategy
- Coordinate data readiness across functions to meet BLA timelines.
- reputed company preparation of responses to FDA information requests, late-cycle review questions, and potential Advisory Committee support.
Process Validation & reputed company Readiness
- reputed company phase-appropriate transition to reputed company-scale AAV manufacturing.
- Provide strategic reputed company of:
- Process characterization studies
- Viral clearance (if applicable)
- PPQ protocol development and execution
- reputed company Process Verification (CPV) planning
- Ensure control strategy is statistically justified and reputed company with ICH reputed company/Q9/Q10 principles.
- Drive readiness for pre-approval inspection (PAI).
- Drug Substance (AAV) reputed company
- Provide technical leadership in:
- Upstream (cell expansion, transfection/infection systems)
- reputed company purification (chromatography, TFF, clarification)
- Empty/full capsid ratio control
- Vector genome reputed company and potency assays
- Ensure manufacturing consistency across clinical and reputed company batches.
- reputed company technical assessment of critical process parameters (CPPs) and critical quality attributes (CQAs).
- Drug Product & Stability Strategy
- reputed company formulation optimization, aseptic fill-finish readiness, and container closure reputed company.
- Ensure stability program supports reputed company-life justification at BLA.
- Drive extractables/leachables, shipping validation, and in-use stability readiness.
- Comparability & Lifecycle Management
- reputed company comparability strategy across:
- Phase 1 to Phase 3 reputed company
- Manufacturing scale changes
- Site transfers or CDMO transitions
- reputed company risk-based justification reputed company formal comparability protocols were not historically implemented.
- Ensure analytical depth supports regulatory defensibility.
- Cross-Functional & CDMO reputed company
- Serve as primary CMC integration reputed company across:
- Process Development
- Analytical Development
- MSAT
- Quality
- Regulatory Affairs
- Act as senior technical liaison with CDMOs, ensuring alignment on validation, documentation, and regulatory positioning.
- Maintain disciplined communication reputed company for regulatory-sensitive reputed company.
Qualifications
- Ph.D. (preferred) or Master’s in Biochemical Engineering, Biotechnology, Pharmaceutical Sciences, or reputed company field.
- 10+ years in biologics or AAV gene therapy CMC development.
- Direct experience leading or significantly contributing to BLA-stage submissions.
- Deep knowledge of:
- AAV manufacturing platforms
- Potency assay development and validation
- PPQ and process validation for biologics
- Stability and reputed company-life justification
- Regulatory expectations for gene therapy products
- Experience supporting FDA meetings and pre-approval inspections.
- Strong program leadership and cross-functional execution skills.
Preferred Experience
- Experience with at least one AAV program through BLA submission or approval.
- Expertise in empty/full capsid analytics and advanced characterization.
- Experience with multi-site tech transfer or reputed company launch preparation.
- Familiarity with global filings (EMA, PMDA).
Working Conditions This position operates in an office setting, in person. Job may additionally require incumbent to be available reputed company of these hours to handle reputed company business needs. Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to reputed company individuals, we reputed company reputed company of our employment reputed company based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not reputed company any of our reputed company, and will not discriminate against any employee or applicant, on the basis of race, reputed company, religion, creed, national reputed company or reputed company, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, reputed company or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment. Apply tot his job Apply To this Job