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

Merck • Upper Gwynedd Township, PA

30d • $173,200 - $272,600

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 position leads late-stage and commercial biologics programs, with a primary focus on upstream processing, and supports licensure and commercial drug substance manufacturing through process development, process characterization, technology transfer, validation, and manufacturing readiness. The role also supports complex modalities, including multi-specific antibody therapeutics, and collaborates with Manufacturing, Quality, Regulatory, internal stakeholders, and external partners.

The position provides technical leadership for laboratory- and manufacturing-scale studies, supports commercial process investigations and lifecycle management, and ensures process and product knowledge are documented and transferred in line with company standards and regulatory expectations. It also authors and reviews technical and regulatory documentation, including content for regulatory submissions.

As a people leader, the successful candidate leads, coaches, and mentors upstream scientists; supports resource planning, staffing, and hiring; and fosters innovation, continuous improvement, scientific rigor, accountability, and operational excellence. The role contributes to division-wide and multi-year planning for capabilities, digital systems, and platform evolution.

Candidates must hold a BS, MS, or PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or a related discipline, with relevant industry experience of 16 or more years for a BS, 12 or more years for an MS, or 8 or more years for a PhD. The salary range is $173,200 to $272,600. The role is regular, offers domestic relocation, requires 10% travel, and does not offer visa sponsorship.

Requirements

• BS, MS, or PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or a related discipline.
• Relevant industry experience: 16 or more years with a BS, 12 or more years with an MS, or 8 or more 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 in 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 articulate 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. and 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-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 understanding of 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 of commercial processes.
• Author and review technical and regulatory documentation, including regulatory submission sections.
• Drive division-wide initiatives aligned with biologics manufacturing and commercialization strategy.
• Influence multi-year planning for capability needs, 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 environment.
• Support resource planning, staffing strategies, hiring decisions, and talent development, including development of future technical leaders and 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, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

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