Senior Director, Chemistry, Manufacturing & Controls (CMC) Lead

OCUGEN OPCO INC•East Whiteland Township, PA

4d•Onsite

About The Position

The Senior Director, CMC Lead is responsible for developing and executing the Chemistry, Manufacturing & Controls (CMC) strategy across Ocugen’s gene therapy pipeline, with primary responsibility for advancing programs through BLA submission and regulatory approval. This role provides strategic leadership for drug substance and drug product development, ensuring that CMC activities support clinical development, regulatory requirements, and commercial manufacturing readiness. The Senior Director will partner closely with the Chief Scientific Officer, R&D, Regulatory Affairs, and Quality to ensure development activities align with GxP expectations and that processes are successfully transitioned from research-stage development into GMP manufacturing. The ideal candidate will bring deep expertise in GMP-compliant development, process characterization, technology transfer, process validation, and commercial manufacturing readiness, with experience supporting gene therapy or advanced biologics programs.

Requirements

PhD strongly preferred (MS considered) in chemistry, biochemistry, chemical engineering, pharmaceutical sciences, or a related life sciences discipline.
12+ years of industry experience in CMC development within biotechnology or pharmaceutical organizations.
Demonstrated leadership experience supporting clinical-stage or late-stage development programs.
Proven expertise in drug substance and/or drug product development, including upstream/downstream process development and fill/finish operations.
Experience supporting IND and BLA regulatory submissions, including preparation of CMC sections of regulatory filings.
Experience working with CDMOs, including technology transfer, process development, and manufacturing oversight.
Strong knowledge of global CMC regulatory expectations, including FDA guidance for gene therapy products and ICH standards.
Demonstrated ability to lead cross-functional development programs in a fast-paced biotech environment.

Nice To Haves

Direct experience in gene therapy, viral vectors, or advanced biologics CMC strongly preferred.
Experience advancing biologics or gene therapy programs from IND through late-stage development preferred.

Responsibilities

CMC Strategy & Program Leadership Develop and execute CMC strategy for drug substance (DS) and drug product (DP) development across Ocugen’s gene therapy portfolio, from IND-enabling studies through BLA submission and commercial launch.
Serve as the senior CMC leader and primary point of contact for all gene therapy CMC activities.
Ensure alignment across research, development, manufacturing, and regulatory requirements.
Provide strategic guidance to R&D teams on GxP expectations to support downstream GMP manufacturing and regulatory requirements for gene therapy BLAs.
Oversee process development, scale-up, manufacturing, and analytical development of viral vector drug substances and drug products.
GMP Development & Technology Transfer Lead the transfer of R&D processes into GMP-compliant manufacturing environments, including internal facilities and CDMOs.
Manage technology transfer activities across internal manufacturing and external partners.
Oversee process characterization, validation strategies, PPQ, and continued process verification (CPV).
Ensure manufacturing readiness for clinical supply (Phase 1–3) and commercial production.
Support development of robust global supply strategies for clinical and commercial programs.
CMC Regulatory Strategy Lead CMC strategy supporting IND, BLA, and global regulatory submissions.
Oversee preparation and review of CMC sections (Module 3) of regulatory filings, ensuring scientific rigor and completeness.
Partner with Regulatory Affairs on interactions with FDA and global health authorities, including Type A/B/C meetings and pre-BLA interactions.
Maintain awareness of evolving regulatory guidance relevant to gene therapy CMC, including CBER guidance and ICH standards (Q8–Q12).
Cross-Functional Leadership Partner closely with Regulatory, Quality, Clinical Development, Program Management, and Operations to ensure integrated execution of CMC development plans.
Identify technical and operational risks and implement mitigation strategies to support development timelines.
Apply risk-based approaches to comparability, stability, manufacturing, and supply chain continuity.
Organizational Leadership Lead CMC development activities through subordinate leaders responsible for drug substance and drug product development.
Build and mentor a high-performing CMC organization with deep gene therapy expertise.
Provide strategic direction for resource planning, vendor/CDMO oversight, and budget management.
Contribute to executive discussions on manufacturing readiness, development strategy, and long-term supply planning.
Provide input to leadership and Board-level discussions regarding pipeline progress and regulatory milestones.