Manufacturing Science and Technology
About The Position
The Director, Manufacturing Science & Technology (MS&T) provides technical leadership for Ocugen’s manufacturing processes across internal and external GMP operations. This role ensures robust, compliant, and efficient commercial manufacturing through oversight of technology transfer, process validation, and continued process verification (CPV). The Director serves as a strategic link between Process Development, Manufacturing, Quality, and Regulatory Affairs, translating development knowledge into GMP control strategies and driving continuous process improvement in alignment with product lifecycle and corporate goals.
Requirements
- Bachelor’s or advanced degree (M.S./Ph.D.) in Chemical Engineering, Biochemical Engineering, or related life sciences discipline.
- 12+ years of experience in biologics, vaccines, or cell and gene therapy manufacturing, with at least 5 years in a leadership role within MS&T, Technical Operations, or Process Validation.
- Proven success leading tech transfer, process validation, and CPV in GMP-regulated environments.
- Strong understanding of process design, process validation lifecycle, control strategy, and GMP manufacturing science.
- Expertise with data analytics and trending for process monitoring and CPV.
- In-depth knowledge of ICH, FDA, and EMA guidance relevant to process validation and lifecycle management.
- Experience supporting regulatory filings (IND, BLA, MAA) and responding to agency questions.
- Demonstrated ability to translate strategy into operational plans and results.
- Exceptional collaboration and influencing skills across cross-functional and external teams.
- Strong organizational and problem-solving capability, able to manage ambiguity and competing priorities.
- Commitment to Ocugen’s values of Integrity, Teamwork, Respect, and Accountability.
Responsibilities
- Partner with senior leadership to define and execute the MS&T strategy aligned with CMC, regulatory, and corporate objectives.
- Develop and manage the technical roadmap for late-stage and commercial manufacturing, supporting BLA readiness, PPQ execution, and lifecycle management.
- Contribute to the development of multi-year operational and capital plans; accountable for functional budgets and resources.
- Lead end-to-end technology transfers from Process Development into GMP manufacturing, including process fit-up, risk assessments, and process characterization.
- Oversee process validation (PPQ) strategy, execution, and documentation in accordance with global regulatory standards (FDA, EMA, ICH Q8–Q11).
- Ensure control strategies are implemented and maintained across manufacturing sites, both internal and external (CDMOs/CMOs).
- Own the Continued Process Verification (CPV) program—establish performance metrics, trend critical process parameters (CPPs), and lead investigations and CAPAs.
- Drive data-driven process improvement initiatives to enhance yield, robustness, and compliance while reducing manufacturing costs.
- Lead root-cause analyses for deviations and implement sustainable corrective and preventive actions.
- Act as the primary MS&T interface with Manufacturing, QA/QC, Regulatory Affairs, and Supply Chain.
- Provide technical support during regulatory submissions, inspections, and audits.
- Coach and develop a high-performing MS&T team; foster technical excellence and knowledge-sharing across the organization.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
