Lead Scientist, Biologics Downstream

Merck

Rahway (NJ)

On-site

USD 173,000 - 273,000

Full time

44 hours ago
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Benefits offered by this job

Annual bonus
Long-term incentive
Medical, dental, vision coverage
401(k)

Job summary

Merck in Rahway, NJ seeks a Principal Scientist (Director) to lead the Biologics Downstream team within BDSC, directing late-stage and commercial programs and shaping downstream strategies. You will mentor scientists, drive tech transfer, scale-up, validation, and collaborate with Manufacturing, Quality, Regulatory, and external partners to enable licensure and commercialization.

This role requires strong leadership, deep biologics know-how, and a track record of delivering complex processes in

Qualifications

  • BS/ MS/ PhD in Chemical Engineering, Biological Engineering, Chemistry, or related field.
  • 14 years (BS), 12 years (MS), or 6 years (PhD) of industry experience.
  • Deep technical expertise in downstream processing of biologics.
  • Proven 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.
  • Strong leadership and collaboration skills within cross-functional, matrixed organizations.

Responsibilities

  • Lead downstream and/or integrated drug substance teams supporting late-stage clinical and commercial programs.
  • Provide technical leadership for laboratory scale and manufacturing scale studies (characterization, validation, investigations, CPV).
  • Serve as a downstream SME across core unit operations and interdependencies with upstream, analytical, and GMP manufacturing.
  • Ensure process and product knowledge is developed, documented, and transferred per company standards and regulatory expectations.
  • Support technology transfer activities to internal and external sites, including scale-up, process validation, and readiness.

Skills

Biologics downstream processing
Leadership
Cross-functional collaboration
Regulatory documentation
Technology transfer
Process development
GMP compliance

Education

BS in Chemical/Biological Eng or related
MS in Chemical/Biological Eng or related
PhD in related field

Job description

Merck in Rahway, NJ seeks a Principal Scientist (Director) to lead the Biologics Downstream team within BDSC, directing late-stage and commercial programs and shaping downstream strategies. You will mentor scientists, drive tech transfer, scale-up, validation, and collaborate with Manufacturing, Quality, Regulatory, and external partners to enable licensure and commercialization.

This role requires strong leadership, deep biologics know-how, and a track record of delivering complex processes in

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