Principal Scientist, Biologics Development

About the role

The Principal Scientist/Director in Biologics Drug Substance Commercialization (BDSC) provides upstream process leadership and laboratory capabilities that advance late-stage pipeline and commercial drug substance manufacturing for biologics. This senior scientific and leadership role supports late-stage and commercial biologics programs with a primary focus on upstream processing, offering the opportunity to lead high-impact scientific work across complex modalities including multi-specific antibody therapeutics while developing talent and shaping upstream strategies that support global manufacturing and regulatory success. The role serves as a key technical leader and collaborator across Manufacturing, Quality, Regulatory, and external partners.

Key responsibilities

• Scientific & technical leadership: 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 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. Influence multi-year planning including capability needs, digital systems, and 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 talent development strategy including developing future technical leaders and building a talent pipeline.

Education

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.

Required experience & skills

• 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.
• Demonstrated commitment to coaching and mentoring scientific staff.
• Excellent written and verbal communication skills with the ability to clearly articulate process science and influence technical decision making.

Preferred experience & skills

• Leadership experience on drug substance working groups or program teams.
• Direct people management experience.
• Hands-on experience with technology transfer, scale-up, and validation of biologics processes.
• Experience developing or supporting multi‑specific antibody therapeutics, including bispecific and other complex antibody formats.
• Experience with late-stage process characterization, viral clearance studies, process performance qualification (PPQ), and validation.
• Experience authoring regulatory submission content (e.g., BLA sections) and/or working with external development or manufacturing partners.
• Working knowledge of analytical characterization of biologics, cGMPs, and U.S./EU regulatory expectations.
• Experience applying lean leadership and operational excellence principles in laboratory or manufacturing environments.

Pay

$173,200.00 – $272,600.00. Position within the range will be based on several factors including relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits including 401(k)
• Paid holidays, vacation, and compassionate and sick days

Schedule

1st shift – Day. Travel requirements: 10%.