Manufacturing Science and Technology

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.

Qualifications

• 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.