Hybrid Principal Scientist, Biologics Drug Substance Commercialization – Director

at MSD

• Job title: Principal Scientist, Biologics Drug Substance Commercialization – Director
• Job type: Full Time
• Experience level: Lead
• Salary: $173,200 - $272,600 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Rahway, United States

About the role

• Principal Scientist leading biopharmaceutical downstream processing in a clinical and commercial environment. Managing a team and collaborating across divisions to support licenses and commercialization.

Responsibilities

• Lead downstream 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 downstream subject matter expert across core unit operations, with a strong understanding of upstream, 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.
• Influence 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 downstream 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.

Requirements

• BS, MS, or PhD in Chemical Engineering, Biological Engineering, Chemistry, or a related discipline
• Minimum Years of experience: Fourteen (14) years (BS), Twelve (12) years (MS), or Six (6) years (PhD) of required industry experience
• Deep technical expertise in downstream processing of biologics
• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days