Principal Scientist, Biologics Development

Job Description

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.

• 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 an 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.

• 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.

• 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.

• 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 talent development strategy, including developing future technical leaders and building a talent pipeline

BS, MS, or PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or a related discipline, with: 16+ years (BS), 12+ years (MS), or 8+ years (PhD) of relevant industry experience.

• Deep technical expertise in cell culture process development and commercialization.
• Demonstrated ability to independently design, direct, execute, analyze, and document all stages of process development.
• Experience supporting biologics commercialization, including late‑stage development and/or commercial manufacturing.
• Proven ability to prioritize and deliver complex objectives in fast paced, dynamic environments.
• Strong leadership and collaboration skills within cross functional, matrixed organizations.
• Action oriented, problem‑solving mindset with a track record of innovation and continuous improvement.
• D…