Director/Principal Scientist, Biologics Drug Substance Commercialization (BDSC)

MSD • Upper Gwynedd Township, PA

19h • $173,200 - $272,600 • Onsite

About The Position

The Principal Scientist/Director in Biologics Drug Substance Commercialization (BDSC) is a senior scientific and leadership role in the Manufacturing Division’s Upstream Cell Culture team. The role supports late-stage clinical and commercial biologics programs, with a primary focus on upstream processing, and helps enable licensure and commercial supply through process development, process characterization, and technology transfer to internal and external manufacturing sites.

The position provides technical leadership across laboratory- and manufacturing-scale studies, including process characterization, validation, investigations, and continued process verification. It serves as an upstream subject matter expert while accounting for downstream, analytical, and GMP manufacturing interdependencies. The role also contributes to manufacturing readiness, lifecycle management, technical and regulatory documentation, and regulatory submissions.

The successful candidate leads and develops a team of upstream scientists, supports staffing and resource planning, and promotes scientific rigor, innovation, continuous improvement, and operational excellence. The role collaborates with Manufacturing, Quality, Regulatory, internal stakeholders, external partners, and contract development and manufacturing organizations. The position is based primarily in West Point, Pennsylvania, with 10% travel. Domestic relocation is available; visa sponsorship is not offered.

Requirements

• BS, MS, or PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or a related discipline.
• Relevant industry experience of 16+ years with a BS, 12+ years with an MS, or 8+ years with a PhD.
• Deep technical expertise in cell culture process development and commercialization.
• 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.
• 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 and a track record of innovation and continuous improvement.
• Commitment to coaching and mentoring scientific staff.
• Excellent written and verbal communication skills, including the ability to explain process science and influence technical decision-making.

Nice To Haves

• 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, such as 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.

Responsibilities

• Lead upstream and/or integrated drug substance teams supporting late-stage clinical and commercial programs, with a focus on licensure and commercialization.
• Provide technical leadership for laboratory- and manufacturing-scale studies supporting process characterization, validation, investigations, and continued process verification.
• Serve as an upstream subject matter expert and account for downstream, analytical, and GMP manufacturing interdependencies.
• Ensure process and product knowledge is developed, documented, and transferred in accordance with company standards and regulatory expectations.
• Support technology transfer 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 material supporting regulatory submissions.
• Drive division-wide initiatives aligned with biologics manufacturing and commercialization strategy.
• Influence multi-year planning for capabilities, digital systems, and platform evolution.
• Represent BDSC on cross-functional and cross-divisional teams and collaborate with internal stakeholders and external partners, including contract development and manufacturing organizations.
• Lead, coach, and mentor upstream scientists, fostering scientific rigor, accountability, and professional growth.
• Promote innovation, continuous improvement, and operational excellence in the laboratory.
• Support resource planning, staffing strategies, and hiring decisions.
• Support talent development, including developing future technical leaders and building a talent pipeline.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.
• Domestic relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior