Position Responsibilities:
- Lead all aspects of analytical development across Scholar Rock's biologics portfolio, from early development through commercialization.
- End-to-end analytical ownership from preclinical through commercial, including lifecycle management of analytical methods.
- Oversight of both internal lab execution and external partnerships (CDMOs, CROs).
- Direct the design, development, qualification, and lifecycle management of analytical methods to support release, stability, comparability, and characterization testing.
- Define and implement phase-appropriate analytical control strategies integrated with QbD principles to support regulatory filings and commercial readiness.
- Establish and maintain product specifications in alignment with critical quality attributes (CQAs), clinical phase, manufacturing process understanding, and statistical justification.
- Collaborate with Process Development to ensure linkage between CQAs and process parameters.
- Oversee developability and manufacturability assessments for biologic drug candidates, integrating analytical data to evaluate protein stability, aggregation, degradation, solubility, charge variants, PTMs, and compatibility with formulation and drug delivery devices.
- Integrate analytical data into formulation selection and device interface development (e.g., high-concentration SubQ).
- Collaborate cross-functionally with Process Development, Formulation, Quality, Regulatory, and external CDMOs to ensure analytical alignment and technical robustness across all stages.
- Drive analytical comparability strategies to support process changes, site transfers, or lifecycle management.
- Define and execute regulatory strategies for analytical sections of CMC submissions (e.g., Module 3), support inspection readiness, and lead interactions with FDA, EMA, PMDA.
- Leverage data analytics platforms and advanced informatics tools to support method trending, OOS/OOT investigation, real-time release testing, and continued process verification.
- Serve as the analytical lead for Health Authority interactions, regulatory submissions (IND, IMPD, BLA/MAA), and inspections.
- Provide strategic leadership in CMC Teams, Analytical Sciences governance, and internal Scientific Review Boards.
- Mentor and grow a team of analytical scientists; foster a culture of scientific excellence, compliance, and technical leadership.
Candidate Requirements:
- Ph.D. in Analytical Chemistry, Biochemistry, or related discipline with 12+ years (or M.S. with 15+ years) of industry experience in analytical development for biologics.
- Proven experience leading analytical development for monoclonal antibodies or complex biologics through all stages of development, including BLA/MAA submission and commercial launch.
- Deep understanding of analytical methods (e.g., cIEF, SEC, CE-SDS, icIEF, LC-MS, peptide mapping, binding assays) and their application in CMC development and regulatory strategy.
- Demonstrated expertise in setting, justifying, and maintaining product specifications across the development lifecycle.
- Experience with developability profiling and integration of analytics into manufacturability risk assessment.
- Strong knowledge of ICH, USP, and regulatory expectations for biologics.
- Excellent leadership, strategic thinking, and communication skills.
Preferred Experience:
- Experience with high-concentration formulations and SubQ delivery.
- Prior leadership of external CDMO/CRO relationships.
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What We Do
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
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