Director, CMC Product Development – Biologics

Job Summary:

The Director, CMC Product Development – Biologics is a senior technical and operational leader responsible for the end-to-end CMC development of biologics drug product candidates, from early formulation through process development, clinical supply, and regulatory submission. Reporting to the Executive Director, CMC Product Development, this individual drives the drug product development strategy for large molecule programs including monoclonal antibodies, fusion proteins, and other biologic modalities. This role works cross-functionally with Analytical Development, Drug Substance Process Development, Quality, Clinical Operations, and external CDMOs to ensure integrated, timeline-aligned delivery of all biologics drug product CMC activities.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Define and execute the biologics drug product development strategy, encompassing formulation development, fill-finish process development, primary container-closure selection, and device development where applicable.
• Lead formulation development activities for protein-based therapeutics, including excipient screening, formulation optimization, forced degradation, and compatibility studies.
• Oversee drug product process development and scale-up, including fill-finish requirements, technology transfer to CDMO partners, process characterization, and validation readiness.
• Author and review biologics drug product sections of regulatory submissions (IND, BLA, Type A/B meeting packages) and lead or support FDA/EMA interactions on drug product CMC topics.
• Select and technically govern CDMO partners responsible for biologics drug product manufacture, including clinical supply chain coordination, change control oversight, and deviation management.
• Collaborate with Analytical Development to define drug product release and stability specifications, in-process controls, and comparability strategies for process and formulation changes.
• Partner with Clinical Operations and Supply Chain to ensure uninterrupted clinical supply across Phase 1–3 trials, including labeling, packaging, and cold chain logistics planning.
• Integrate Quality by Design (QbD) principles, Design of Experiments (DoE), and risk management tools into biologics drug product development decisions.
• Evaluate novel drug delivery technologies, and device requirements as applicable to the biologics pipeline, including prefilled syringe and autoinjector platforms.
• Contribute to CMC due diligence assessments and portfolio planning by evaluating the manufacturability and development feasibility of biologic drug product candidates.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a closely related discipline; or equivalent work experience.
• 10+ years of CMC biologics experience with demonstrated expertise in drug product formulation and/or fill-finish process development in pharmaceutical and/or biotechnology industry
• Deep technical expertise in biologics formulation science, including protein stability, aggregation mitigation, excipient selection, lyophilization cycle development, and container-closure systems.
• Comprehensive knowledge of ICH Q8/Q9/Q10/Q11, relevant biologics CMC guidelines (Q5A–Q5E), and FDA/EMA drug product development expectations; experience authoring BLA drug product sections.
• Proven experience managing biologics drug product CDMO relationships, including technical oversight of fill-finish operations, process scale-up, process qualification, and commercial readiness.
• Experience with lyophilized and liquid formulation development for parenteral biologics, including primary packaging compatibility and extractables/leachable considerations.
• Working knowledge of biologics drug substance processes (upstream/downstream) sufficient to effectively partner with Drug Substance teams on interface activities and integrated CMC planning.
• Proven track record of operating effectively in pre-commercial, resource-constrained environments — balancing strategic vision with hands-on execution and infrastructure building.
• Experience managing cross-functional stakeholder relationships at the senior level, with the ability to influence without authority and align diverse teams around shared program goals.
• Exceptional ability to translate complex CMC biologics science into clear, decision-ready narratives for executive leadership, cross-functional partners, and non-technical stakeholders.
• Strong written and verbal communication skills, with a track record of authoring high-quality regulatory documents, scientific reports, and executive-level presentations.
• Collaborative communication style with the ability to establish trust quickly across Research, Clinical, Regulatory, Quality, and external partners in a matrixed organization.