Senior Director, CMC Process Development

Senior Director, CMC Process Development

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 and drug product processesboth internally and through a global network of CDMOs. Expertise in high-concentration biologics is essential.

The ideal candidate combines deep 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.

Position 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 internal and external manufacturing sites.
• Drive the development of high-concentration formulations suitable for subcutaneous administration (e.g., >

100 mg / mL), including associated drug product process characterization.

Candidate Qualifications :

$240,000 - $330,000 a year

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.