Manufacturing Science and Technology

Position Purpose

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.

Responsibilities

Strategic & Functional Leadership

• 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.

Technology Transfer & Process Validation

• 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).

Process Performance & Lifecycle Management

• 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.

Cross-Functional Collaboration

• 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.

• 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.

Working Conditions

This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, 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, current 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.