Senior Director, CMC Process Development

Role Summary

We are seeking an experienced and strategic Senior Director of CMC Process Development to lead our biologics process development function across early-stage, late-stage, and commercial programs. This role will drive the design, scale-up, and technology transfer of drug substance processes—both internally and through a global network of CDMOs. Expertise with drug substance process development for high-concentration biologics is essential.

Responsibilities

• Strategic & Functional Leadership
• Lead the CMC process development strategy for biologics (mAbs, fusion proteins, or similar), including upstream and downstream development.
• Serve as the enterprise thought leader for biologics manufacturing platforms, innovation, and process robustness.
• Partner with stakeholders across R&D, Regulatory, Manufacturing, and Quality to ensure alignment from development to commercial readiness.
• Technical Program Oversight
• Design and oversee process development programs across all stages (early/IND-enabling through BLA/commercial lifecycle).
• Guide scale-up, technology transfer, and validation activities across external manufacturing sites.
• Enable robust process ownership and technical oversight for clinical and commercial manufacturing.
• External CDMO Management
• Manage and oversee relationships with CDMOs for drug substance development, ensuring scientific rigor, quality, and timelines.
• Serve as the technical lead for external development and manufacturing partnerships, including CDMO selection and oversight of SOWs, budgets, and technical deliverables.
• Organizational Development
• Build and lead a high-performing CMC process development team, including technical experts and project leaders.
• Foster a culture of scientific excellence, cross-functional collaboration, and accountability.
• Regulatory Support
• Author and/or review CMC sections of regulatory submissions (IND, IMPD, BLA/MAA), including process descriptions, validation strategies, and control strategies.
• Support regulatory agency interactions, inspections, and responses to information requests.

Qualifications

• Required:
• Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field.
• 12+ years of relevant experience in biopharmaceutical process development, with at least 5 years in a leadership role.
• Proven experience developing biologics processes from early-stage through commercial launch, including PPQ and lifecycle management.
• Demonstrated expertise in drug substance process development of high-concentration biologics to mitigate drug product development challenges.
• Strong background in tech transfer, scale-up, and working with external CDMOs.
• Experience with process ownership and technical oversight for clinical and commercial manufacturing.
• Experience supporting global regulatory submissions (e.g., FDA, EMA).
• Preferred:
• Experience in a lean, entrepreneurial biotech environment.
• Familiarity with integrated CMC program leadership or technical operations governance frameworks

Skills

• Strategic and enterprise mindset
• Deep technical expertise with strong decision-making capability
• Effective communicator with cross-functional and external partners
• Proactive, solution-oriented leadership style
• High standards of scientific rigor and compliance

Education

• Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field.