Principal Scientist, Biologics Development

Job Description Summary: Principal Scientist/Director, Biologics Drug Substance Commercialization Join Our Company's Manufacturing Division as a Principal Scientist/Director in Biologics Drug Substance Commercialization (BDSC). This senior leadership role is responsible for driving late-stage and commercial biologics programs, focusing on upstream cell culture and commercialization. The position oversees a team of scientists, leads high-impact process development, and manages technology transfer and validation activities to support licensure and commercial manufacturing. Key responsibilities include providing technical leadership in process characterization, ensuring regulatory compliance, collaborating across cross-functional teams, and fostering innovation and operational excellence. Candidates should possess deep expertise in upstream biologics processing, proven experience in commercialization and scale-up, and strong leadership skills. Preferred qualifications include people management skills, hands‑on experience with advanced antibody therapeutics, regulatory submissions, and familiarity with analytical methods, cGMPs, and lean leadership principles. Educational requirements include a BS, MS, or PhD in a relevant discipline with substantial industry experience. Join Our Team as a Principal Scientist/ Director in Biologics Drug Substance Commercialization! Are you ready to make a significant impact in the world of cell culture process development & commercialization? At Our Company , we are at the forefront of innovation in the Manufacturing Division , specifically within the Biologics Drug Substance Commercialization (BDSC) team. Our Upstream Cell Culture department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products into reality. Position Overview Within Our Company's Manufacturing Division, Biologics Drug Substance Commercialization (BDSC) provides upstream process leadership and laboratory capabilities that advance late-stage pipeline and commercial drug substance manufacturing for biologics. The BDSC organization plays a critical role in enabling licensure and commercial supply by delivering second generation process development, robust process characterization, and seamless technology transfer to internal and external manufacturing sites. The Principal Scientist/ Director position in BDSC-Upstream team is a senior scientific and leadership role supporting late stage and commercial biologics programs, with a primary focus on biologics upstream processing. This position offers the opportunity to lead high impact scientific work across complex modalities, including multi-specific antibody therapeutics-while developing talent and shaping upstream strategies that directly support global manufacturing and regulatory success. The Principal Scientist/ Director will serve as a key technical leader and collaborator across Manufacturing, Quality, Regulatory, and external partners. Key Responsibilities Lead upstream and/or integrated drug substance teams supporting late-stage clinical and commercial programs, with clear line of sight to licensure and commercialization. Provide technical leadership for laboratory scale and manufacturing scale studies supporting process characterization, validation, investigations, and continued process verification. Serve as a upstream subject matter expert across core unit operations, with a strong understanding of downstream, analytical, and GMP manufacturing interdependencies. Ensure process and product knowledge are developed, documented, and transferred in alignment with company standards and regulatory expectations. Commercialization & Technology Transfer Support technology transfer activities to internal and external manufacturing sites, including scale‑up, process validation, and manufacturing readiness. Contribute to manufacturing investigations and lifecycle management activities for commercial processes. Author and review technical and regulatory documentation, including sections supporting regulatory submissions. Strategic & Cross Functional Impact Drive division wide initiatives aligned with biologics manufacturing and commercialization strategy. Influencing multi-year planning: capability needs, digital systems, platform evolution. Represent BDSC on cross functional and cross divisional teams. Actively collaborate with internal stakeholders and external partners, including contract development and manufacturing organizations. People Leadership & Development Lead, coach, and mentor a team of upstream scientists, fostering scientific rigor, accountability, and professional growth. Promote a culture of innovation, continuous improvement, and operational excellence within the laboratory environment. Support the leadership team with resource planning, staffing strategies, and hiring decisions Support tale #J-18808-Ljbffr Merck