Principal Scientist, Biologics Drug Substance Commercialization – Director
MSD
full-time
Posted on:
Location Type: Hybrid
Location: Rahway • New Jersey • Pennsylvania • United States
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Salary
💰 $173,200 - $272,600 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
downstream processingprocess characterizationprocess validationmanufacturing readinesstechnical documentationregulatory submissionsbiologics commercializationprocess developmentanalytical methodsGMP manufacturing
Soft Skills
leadershipcollaborationcoachingmentoringproblem-solvinginnovationcontinuous improvementcommunicationaccountabilityresource planning