Director, Upstream MSAT & Process Development

Role Summary

We are seeking an experienced and strategic Director of Upstream MSAT and Process Development within Technical Operations (CMC) to lead our biologics upstream MSAT and process development function across early-stage, late-stage, and commercial programs. This role will support externally partnered GMP production of Scholar Rock’s clinical and commercial assets with deep manufacturing science and technology expertise. The candidate will also drive the design, scale-up, and technology transfer of drug substance processes—both internally and through a global network of CDMOs. The ideal candidate combines deep upstream technical knowledge, strong organizational leadership, and proven experience managing external collaborations and in-house teams. This role is critical to ensuring robust, scalable, processes that support clinical and commercial success.

Responsibilities

• 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.
• 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.
• 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.
• Build and lead a high-performing CMC upstream MSAT and process development team.
• Foster a culture of scientific excellence, cross-functional collaboration, and accountability.
• 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.

Qualifications

• Required: Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field.
• Required: 8+ years of relevant biopharmaceutical experience encompassing both MSAT and process development functions; at least 4 years in a leadership role(s).
• Required: Proven experience developing biologics processes from early-stage through commercial launch, including PPQ and lifecycle management.
• Required: Demonstrated expertise in drug substance process development of high-concentration biologics to mitigate drug product development challenges.
• Required: Strong background in tech transfer, scale-up, and working with external CDMOs.
• Required: Experience with process ownership and technical oversight for clinical and commercial manufacturing.
• Required: Experience supporting global regulatory submissions (e.g., FDA, EMA).
• Preferred: Experience in a lean, entrepreneurial biotech environment.
• Preferred: 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