Director-Level Downstream Biologics Scientist

Merck & Co.; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical benefits

Retirement benefits (401(k))

Paid holidays & vacation

Job summary

Merck & Co. is seeking a Senior Principal Scientist (Director level) in its Biologics Drug Substance Commercialization team.

You will lead downstream processing efforts for late-stage and commercial biologics, shaping strategies, and mentoring a multidisciplinary team across Manufacturing, Quality, and Regulatory functions. You will collaborate with internal and external partners to enable regulatory success and scale-up, contributing to lifecycle management and strategic planning in a

Qualifications

• BS/MS/PhD in a relevant field.
• 14+ years (BS), 12+ years (MS), or 6+ years (PhD) of industry experience.
• Deep expertise in downstream processing of biologics.

Responsibilities

• Lead downstream and integrated teams supporting late-stage and commercial programs.
• Provide technical leadership for lab and manufacturing scale studies.
• Serve as downstream SME across core unit operations and interdependencies.
• Ensure process knowledge is documented and transferred per regulatory standards.
• Lead technology transfer and lifecycle management activities.
• Author/regulatory documentation for submissions.
• Drive cross-divisional initiatives and multi-year planning.
• Mentor and develop a team of downstream scientists.

Skills

Biological Engineering

Biologics

Biopharmaceutical Manufacturing

Bioproduction

Bioproducts

Chemical Engineering

Commercialization

Cross-Functional Teamwork

Decision Making

Downstream Processing

Drug Development

Manufacturing Scale-Up

Process Characterization

Process Development (PD)

Process Transfers

Purification Methods

Strategic Thinking

Technology Transfer

Education

BS in Chemical Engineering

MS in Biological Engineering

PhD in Chemical Engineering

Job description

Merck & Co. is seeking a Senior Principal Scientist (Director level) in its Biologics Drug Substance Commercialization team.

You will lead downstream processing efforts for late-stage and commercial biologics, shaping strategies, and mentoring a multidisciplinary team across Manufacturing, Quality, and Regulatory functions. You will collaborate with internal and external partners to enable regulatory success and scale-up, contributing to lifecycle management and strategic planning in a