Scholar Rock
Senior Director, Analytical Development
Scholar Rock, Cambridge, Massachusetts, United States, 02141
Senior Director, Analytical Development
Scholar Rock is seeking an accomplished and strategic Senior Director of Analytical Development to lead analytical activities supporting the development and commercialization of innovative biologics, including monoclonal antibodies, fusion proteins, and bispecifics. This highly visible leadership role will oversee method development, characterization, analytical control strategies, and regulatory submissions spanning early-stage development through commercial lifecycle management. The ideal candidate will be a hands-on scientific leader with deep expertise in protein analytics and a strong track record of advancing programs from IND through BLA. 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. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Scholar Rock is seeking an accomplished and strategic Senior Director of Analytical Development to lead analytical activities supporting the development and commercialization of innovative biologics, including monoclonal antibodies, fusion proteins, and bispecifics. This highly visible leadership role will oversee method development, characterization, analytical control strategies, and regulatory submissions spanning early-stage development through commercial lifecycle management. The ideal candidate will be a hands-on scientific leader with deep expertise in protein analytics and a strong track record of advancing programs from IND through BLA. 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. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.