Merck
Associate Principal Scientist, Engineering- Cell Culture Sciences, Biologics Dru
Merck, Rahway, New Jersey, us, 07065
Overview
Associate Principal Scientist, Engineering- Cell Culture Sciences, Biologics Drug Substance Commercialization
at Merck. This role provides strategic and technical leadership in cell culture commercialization to support late-stage pipeline commercialization and post-market commercial manufacturing support within the Biologics Drug Substance Commercialization (BDSC) group. The BDSC, Cell Culture Sciences department supports stage 1 & 2 process validation deliverables under applicable regulatory guidance, pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, second generation process development, and regulatory submissions. Responsibilities
Coordinate project planning, resourcing, progress reporting, troubleshooting, and people management. Serve as the scientific/technical mentor for junior staff and provide guidance in cell culture process development and commercialization for large molecule products. Lead process development, process characterization, and regulatory filing activities to enable smooth paths to PPQs and BLAs for the company’s pipeline. Manage large multifaceted projects as the leader of cross-functional teams; ensure technical quality, reliability, schedule, and cost targets are met. Monitor performance and recommend schedule changes, cost adjustments, or resource additions. Solve technical and non-technical problems throughout the project lifecycle, with emphasis on early design and planning phase resolution. Provide timely status updates to project sponsors and management. Champion compliance, safety, and a culture of diversity, inclusion, and equity. Minimum Education Requirement and Experience
Bachelor’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with eight (8) years of relevant industry experience. OR Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with six (6) years of relevant industry experience. OR Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or related field with four (4) years of relevant industry experience. Required Experience and Skills
Strong fundamental knowledge and subject matter expertise in mammalian cell culture processing of biologics (large molecules), including recent advances and challenges. Experience independently conducting and directing planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Experience with late-stage commercial process development (CPD), technology transfer (TT), scale-down model qualification (SDMQ), and process characterization (PC). Experience authoring technical documentation for PC, PPQ, RA, control strategy, process comparability, and regulatory submissions (BLA/MAA/JNDA, etc.). Ability to prioritize and deliver complex objectives on tight timelines in a rapidly changing environment. Leadership and collaboration in cross-functional, matrixed teams. Action-oriented, creative, initiative-taking, and problem-solving mindset. Experience coaching and mentoring staff to maximize talent development. Excellent interpersonal and communication skills. Preferred Experience and Skills
Experience leading CMC development teams. Experience with cell culture process development for biologics. Experience with high-throughput microbioreactor systems and advanced in situ analytics for process monitoring and control. Experience with modern cell culture processes including intensified inoculum/fed-batch and perfusion process development. Background in data science related to cell culture and predictive modeling (e.g., MFA, omics, machine learning; PAT integration). Experience with GMP manufacturing support, batch record reviews, and operations. Experience with mathematical modeling, scaling calculations, comparability, QbD, CFD, and Lean Six Sigma. Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies. Additional Information
US and Puerto Rico residents only. Candidates may need relocation and visa sponsorship may be required. This role offers a hybrid work model in the U.S. and Puerto Rico, with on-site requirements as defined by the company policies. EEO statement: Merck is an equal opportunity employer. We prohibit discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics.
#J-18808-Ljbffr
Associate Principal Scientist, Engineering- Cell Culture Sciences, Biologics Drug Substance Commercialization
at Merck. This role provides strategic and technical leadership in cell culture commercialization to support late-stage pipeline commercialization and post-market commercial manufacturing support within the Biologics Drug Substance Commercialization (BDSC) group. The BDSC, Cell Culture Sciences department supports stage 1 & 2 process validation deliverables under applicable regulatory guidance, pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, second generation process development, and regulatory submissions. Responsibilities
Coordinate project planning, resourcing, progress reporting, troubleshooting, and people management. Serve as the scientific/technical mentor for junior staff and provide guidance in cell culture process development and commercialization for large molecule products. Lead process development, process characterization, and regulatory filing activities to enable smooth paths to PPQs and BLAs for the company’s pipeline. Manage large multifaceted projects as the leader of cross-functional teams; ensure technical quality, reliability, schedule, and cost targets are met. Monitor performance and recommend schedule changes, cost adjustments, or resource additions. Solve technical and non-technical problems throughout the project lifecycle, with emphasis on early design and planning phase resolution. Provide timely status updates to project sponsors and management. Champion compliance, safety, and a culture of diversity, inclusion, and equity. Minimum Education Requirement and Experience
Bachelor’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with eight (8) years of relevant industry experience. OR Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with six (6) years of relevant industry experience. OR Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or related field with four (4) years of relevant industry experience. Required Experience and Skills
Strong fundamental knowledge and subject matter expertise in mammalian cell culture processing of biologics (large molecules), including recent advances and challenges. Experience independently conducting and directing planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Experience with late-stage commercial process development (CPD), technology transfer (TT), scale-down model qualification (SDMQ), and process characterization (PC). Experience authoring technical documentation for PC, PPQ, RA, control strategy, process comparability, and regulatory submissions (BLA/MAA/JNDA, etc.). Ability to prioritize and deliver complex objectives on tight timelines in a rapidly changing environment. Leadership and collaboration in cross-functional, matrixed teams. Action-oriented, creative, initiative-taking, and problem-solving mindset. Experience coaching and mentoring staff to maximize talent development. Excellent interpersonal and communication skills. Preferred Experience and Skills
Experience leading CMC development teams. Experience with cell culture process development for biologics. Experience with high-throughput microbioreactor systems and advanced in situ analytics for process monitoring and control. Experience with modern cell culture processes including intensified inoculum/fed-batch and perfusion process development. Background in data science related to cell culture and predictive modeling (e.g., MFA, omics, machine learning; PAT integration). Experience with GMP manufacturing support, batch record reviews, and operations. Experience with mathematical modeling, scaling calculations, comparability, QbD, CFD, and Lean Six Sigma. Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies. Additional Information
US and Puerto Rico residents only. Candidates may need relocation and visa sponsorship may be required. This role offers a hybrid work model in the U.S. and Puerto Rico, with on-site requirements as defined by the company policies. EEO statement: Merck is an equal opportunity employer. We prohibit discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics.
#J-18808-Ljbffr