Rapt
Overview
The Director of Biologics Product Development reports to the SVP, Technical Operations and is responsible for development of biologics drug product presentations and processes, oversee technology transfer to and manufacturing at CDMOs, and deliver robust product supply for late-stage global clinical trials and commercialization. It is the subject matter expert in pre-filled syringe (PFS) manufacturing with the CMC team, providing strategic guidance and technical leadership across cross-functional teams. Major Duties and Responsibilities
Lead all aspects of biologics drug product development from early development through commercialization. Develop late-stage and commercial launch strategy for PFS development and manufacturing. Be the subject matter expert in PFS process development and sterile fill/finish manufacturing processes, providing technical guidance and strategic insights to cross-functional teams. Accountable for manufacturing and on-time delivery of clinical supplies from CDMOs to support late-stage global clinical trials. Work with Quality and Analytical Development in reviewing batch records and releasing clinical batches in a timely manner. Responsible for developing phase-appropriate development strategies for drug product development, stability batches, process scale up, process characterization, process qualification (PPQ), and commercial readiness. Lead all manufacturing activities at the CDMO to meet the requirements of registration stability batches and drug product process validation. Analyze, organize, and present technical development and manufacturing data at CMC meetings and identify opportunities for process improvement and optimization. Define and implement drug product control strategies integrated with QbD principles, as needed, to support regulatory filings and commercial readiness. Collaborate with Analytical Development to establish product specifications in alignment with critical quality attributes (CQAs), manufacturing process understanding, and statistical justification. Collaborate with Process Development and Device Engineering to ensure linkage between CQAs and process parameters. Plan and execute on all drug product-related process studies to support the pharmaceutical development and manufacturing process development sections of CMC Module 3 to support BLA submission. Collaborate cross-functionally with Process Development, Device Engineering, Quality, CMC Regulatory, and external CDMOs to ensure alignment and technical robustness across all stages. Author and review drug product sections of the regulatory submissions (e.g., Module 3, IND, BLA, Briefing book). Education Requirements
PhD in Pharmaceutical Sciences, Chemical Engineering, or Biochemical Engineering with 12+ years (or M.S. with 15+ years) of industry experience in sterile process development for biologics. 5+ years of managerial experience in directing internal biologics development teams or at CDMOs Experience Requirements
Proven track record in advancing injectable biologics drug products, especially monoclonal antibodies in PFS, from early development through commercialization Have led a process qualification campaign for commercial readiness for a monoclonal antibody formulation in PFS Strong technical leadership, project management, and cross-functional collaboration skills Experience with the device aspects of combination products, such as auto-injector is preferred Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a dynamic and fast-paced environment. Broad experience in cGMP biologics manufacturing and understanding of ICH regulatory guidelines. Other Qualifications
Must have a creative and strategic attitude with the ability to work in a fast-paced environment Strong sense of urgency and ability to deliver in a highly fast paced environment Require excellent written/oral communication. Travel up to 25% California law requires pay information in job postings. The specific rate will depend on the successful candidates qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $225,600 (entry-level qualifications) & $244,600 (highly experienced). #J-18808-Ljbffr
The Director of Biologics Product Development reports to the SVP, Technical Operations and is responsible for development of biologics drug product presentations and processes, oversee technology transfer to and manufacturing at CDMOs, and deliver robust product supply for late-stage global clinical trials and commercialization. It is the subject matter expert in pre-filled syringe (PFS) manufacturing with the CMC team, providing strategic guidance and technical leadership across cross-functional teams. Major Duties and Responsibilities
Lead all aspects of biologics drug product development from early development through commercialization. Develop late-stage and commercial launch strategy for PFS development and manufacturing. Be the subject matter expert in PFS process development and sterile fill/finish manufacturing processes, providing technical guidance and strategic insights to cross-functional teams. Accountable for manufacturing and on-time delivery of clinical supplies from CDMOs to support late-stage global clinical trials. Work with Quality and Analytical Development in reviewing batch records and releasing clinical batches in a timely manner. Responsible for developing phase-appropriate development strategies for drug product development, stability batches, process scale up, process characterization, process qualification (PPQ), and commercial readiness. Lead all manufacturing activities at the CDMO to meet the requirements of registration stability batches and drug product process validation. Analyze, organize, and present technical development and manufacturing data at CMC meetings and identify opportunities for process improvement and optimization. Define and implement drug product control strategies integrated with QbD principles, as needed, to support regulatory filings and commercial readiness. Collaborate with Analytical Development to establish product specifications in alignment with critical quality attributes (CQAs), manufacturing process understanding, and statistical justification. Collaborate with Process Development and Device Engineering to ensure linkage between CQAs and process parameters. Plan and execute on all drug product-related process studies to support the pharmaceutical development and manufacturing process development sections of CMC Module 3 to support BLA submission. Collaborate cross-functionally with Process Development, Device Engineering, Quality, CMC Regulatory, and external CDMOs to ensure alignment and technical robustness across all stages. Author and review drug product sections of the regulatory submissions (e.g., Module 3, IND, BLA, Briefing book). Education Requirements
PhD in Pharmaceutical Sciences, Chemical Engineering, or Biochemical Engineering with 12+ years (or M.S. with 15+ years) of industry experience in sterile process development for biologics. 5+ years of managerial experience in directing internal biologics development teams or at CDMOs Experience Requirements
Proven track record in advancing injectable biologics drug products, especially monoclonal antibodies in PFS, from early development through commercialization Have led a process qualification campaign for commercial readiness for a monoclonal antibody formulation in PFS Strong technical leadership, project management, and cross-functional collaboration skills Experience with the device aspects of combination products, such as auto-injector is preferred Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a dynamic and fast-paced environment. Broad experience in cGMP biologics manufacturing and understanding of ICH regulatory guidelines. Other Qualifications
Must have a creative and strategic attitude with the ability to work in a fast-paced environment Strong sense of urgency and ability to deliver in a highly fast paced environment Require excellent written/oral communication. Travel up to 25% California law requires pay information in job postings. The specific rate will depend on the successful candidates qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $225,600 (entry-level qualifications) & $244,600 (highly experienced). #J-18808-Ljbffr