Innovation Lead: Sterile Drug Product Commercialization

MSD; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

401(k) retirement plan

Job summary

Merck & Co., Inc. is seeking a Principal Scientist to lead biologics process development, scale-up, and tech transfer for late-stage and commercial products. The role emphasizes process characterization, validation, and CMC strategies across global sites.

The candidate will drive PPQ readiness, regulatory submissions, and continuous improvement in sterile manufacturing, with a focus on high-performance teamwork and scientific leadership.

Qualifications

• Education minimums: Bachelor/Master/PhD in related field with progressive experience.
• Experience with biologics process development and scale-up.
• In-depth knowledge of sterile drug product fill-finish operations and tech transfer.

Responsibilities

• Lead and oversee DP design, development, characterization, tech transfer and robust validation.
• Drive PPQ readiness, regulatory filings and inspection readiness.

Skills

Biologics process development

Technology transfer

Process characterization

PPQ readiness

Regulatory submissions

Process validation

Education

Bachelor's degree in Chemical/Biochemical/Bioengineering or related field

Master's degree in Chemical/Biochemical/Bioengineering or related field

Ph.D. in Chemical/Biochemical/Bioengineering or related field

Tools

DOE design

Statistical methods (SPC, MVA)

Quality by Design (QbD)

Analytical method development

Job description

Merck & Co., Inc. is seeking a Principal Scientist to lead biologics process development, scale-up, and tech transfer for late-stage and commercial products. The role emphasizes process characterization, validation, and CMC strategies across global sites.

The candidate will drive PPQ readiness, regulatory submissions, and continuous improvement in sterile manufacturing, with a focus on high-performance teamwork and scientific leadership.