Biologics Downstream Director: Process & Strategy Lead

Merck; West Point (PA); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck is seeking a Principal Scientist (Director) to lead the Biologics Downstream team within the BDSC-Downstream group. The role focuses on transforming late-stage biologics into commercial products, guiding technical strategy, and mentoring a team of downstream scientists across manufacturing, QA, and regulatory interfaces.

The incumbent will drive process development, technology transfer, and lifecycle management, influencing multi-year planning and platform evolution while ensuring

Qualifications

• BS, MS, or PhD in Chemical Engineering, Biological Engineering, Chemistry, or a related discipline.
• 14 years (BS), 12 years (MS), or 6 years (PhD) of required 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.

Responsibilities

• Lead downstream and integrated drug substance teams supporting late-stage clinical and commercial programs with licensure and commercialization focus.
• Provide technical leadership for laboratory and manufacturing scale studies (characterization, validation, investigations, PV).
• Serve as a downstream subject matter expert across core unit operations with an understanding of upstream, analytical, and GMP interdependencies.
• Ensure process and product knowledge are documented and transferred per company standards and regulatory expectations.
• Support technology transfer activities to internal and external sites, including scale-up and validation.

Skills

Downstream processing

Team leadership

Regulatory documentation

Process characterization

GMP manufacturing

Education

BS/MS/PhD in Chemical/ Biological Engineering or related

Job description

Merck is seeking a Principal Scientist (Director) to lead the Biologics Downstream team within the BDSC-Downstream group. The role focuses on transforming late-stage biologics into commercial products, guiding technical strategy, and mentoring a team of downstream scientists across manufacturing, QA, and regulatory interfaces.

The incumbent will drive process development, technology transfer, and lifecycle management, influencing multi-year planning and platform evolution while ensuring