Senior Scientist, Sterile DP Process Development

MSD; Upper Gwynedd Township (Montgomery County); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co., Inc. seeks a Senior Scientist in our SDPC group to lead commercial DP process development studies for biologics and sterile products. You will develop scalable manufacturing processes, transfer technology to DP sites, and improve robustness to support faster launch timelines.

The role involves execution of DOE-based experiments, collaboration with cross‑functional teams, and preparation of regulatory documentation. Travel up to 25% may be required, based in West Point, PA.

Qualifications

• BS in a relevant science with 6+ years of DP process development experience.
• MS with 4+ years of experience in sterile drug product manufacturing or related field.
• PhD with no industry experience considered.
• Experience in sterile drug product process development, scale‑up, and tech transfer.

Responsibilities

• Design and execute studies to develop and characterize sterile drug product processes.
• Develop and transfer robust processes to commercial DP manufacturing sites.
• Build strategy and framework for process validation at commercial sites.
• Manage DP activities for inline and pipeline programs including regulatory filings.
• Ensure DOE and robust experimental design are used where applicable.
• Author technical protocols and reports for regulatory submissions.

Skills

Adaptability

Biochemistry

Biologics

Bioprocess Engineering

Bioproducts

Bioreactors

Biotechnology

cGMP Regulations

Chemical Engineering

Chemistry

Chromatographic Techniques

Clinical Judgment

Clinical Manufacturing

Commercialization

Design of Experiments (DOE)

Detail-Oriented

GMP

Process Design

Process Development (PD)

Process Optimization

Process Scale Up

Process Verification

Regulatory Submissions

Sample Management

Education

BS in Chemical Engineering or related field

MS in Chemical Engineering or related field

PhD in related field

Job description

Merck & Co., Inc. seeks a Senior Scientist in our SDPC group to lead commercial DP process development studies for biologics and sterile products. You will develop scalable manufacturing processes, transfer technology to DP sites, and improve robustness to support faster launch timelines.

The role involves execution of DOE-based experiments, collaboration with cross‑functional teams, and preparation of regulatory documentation. Travel up to 25% may be required, based in West Point, PA.