Director, Upstream MSAT & Process Development

Position Responsibilities:

• Strategic & Functional Leadership:
• Lead the CMC upstream MSAT and process development team for biologics (mAbs, fusion proteins, or similar).
• Serve as the upstream processes 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 upstream process development 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. 
• Author upstream technical reports to enable program stage progression and robust regulatory filing input.
• External CDMO Management:
• Manage relationships with CDMOs for upstream process development, ensuring scientific rigor, quality, and timelines.
• Serve as the technical upstream lead for external development and manufacturing partnerships, including CDMO selection and oversight of SOWs, budgets, and technical deliverables.
• Enable successful delivery of clinical and commercial product through deviation and batch record review, change control oversight, and person-in-plan support.
• Organizational Development:
• Build and lead a high-performing CMC upstream MSAT and process development team
• Foster a culture of scientific excellence, cross-functional collaboration, and accountability.
• Regulatory Support:
• Author and/or review relevant 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.

Candidate Requirements

• Required:
• Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field.
• 8+ years of relevant biopharmaceutical experience encompassing both MSAT and process development functions; at least 4 years in a leadership role(s).
• 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.
• Competencies:
• 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