Director, Downstream Biologics for Commercialization

MSD Malaysia; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical/Dental/Vision benefits

401(k) plan with company match

Paid holidays & vacation

Job summary

Merck & Co., Inc., Rahway, NJ, USA seeks a Principal Scientist/Director (Downstream) in Biologics Drug Substance Commercialization (BDSC). Lead downstream teams, guide lab- and manufacturing-scale studies, and coordinate tech transfer for late-stage and commercial biologics.

Collaborate across Manufacturing, Quality, Regulatory, and external partners while mentoring scientific staff. You will shape downstream strategies, drive lifecycle management, and influence long-term capability needs in a

Qualifications

• BS/MS/PhD in Chemical Engineering, Biological Engineering, Chemistry, or related discipline.
• Experience in downstream processing of biologics and commercialization.
• Strong collaboration and leadership across cross-functional teams.

Responsibilities

• Lead downstream teams supporting late-stage and commercial programs with line of sight to licensure.
• Provide technical leadership for lab-scale and manufacturing-scale studies (process characterization, validation, investigations, PPQ).
• Serve as downstream SME across unit operations with interdependencies to upstream, analytical, and GMP manufacturing.
• Ensure knowledge transfer and documentation per regulatory expectations; support tech transfer to manufacturing sites.
• Author and review technical and regulatory documentation for submissions; drive division initiatives and platform evolution.
• Coach and mentor downstream scientists; promote innovation and operational excellence.

Skills

Downstream Processing

Biologics

Technology Transfer

Process Characterization

Leadership

Regulatory Submissions

Cross-Functional

Team Leadership

Education

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

Job description

Merck & Co., Inc., Rahway, NJ, USA seeks a Principal Scientist/Director (Downstream) in Biologics Drug Substance Commercialization (BDSC). Lead downstream teams, guide lab- and manufacturing-scale studies, and coordinate tech transfer for late-stage and commercial biologics.

Collaborate across Manufacturing, Quality, Regulatory, and external partners while mentoring scientific staff. You will shape downstream strategies, drive lifecycle management, and influence long-term capability needs in a