Principal Scientist, Engineering - Sterile Drug Product Commercialization, Biologics

MSD

Remote

Quick summary

Work type
Remote
Location
West Point, PA
Salary
$173,200–$272,600 / yr
Posted
3 days ago
Closes
Jun 30, 2026
Nearby
99+ roles within 25 mi

Market check

Salary context

Above market

How this pay compares to similar roles

Similar $198k
This role $223k
$138k most similar roles pay here $287k

This role pays more than 70% of similar roles. Most pay $160,625–$235,750 — the shaded band above. At the midpoint, this role pays about $223k versus about $198k for comparable roles.

Based on 239 similar postings.

Employer

About MSD

MSD (Merck Sharp & Dohme) is the international name for Merck & Co., a major U.S.-based pharmaceutical company.

MSD currently has 16 open roles on FindRole.

Listed pay typically runs $142,400–$224,100 across 16 roles with salary data.

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At a glance

TL;DR · Principal Scientist, Engineering - Sterile Drug Product Commercialization, Biologics

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The Principal Scientist role in Our Company’s Manufacturing Division focuses on advancing and commercializing biologics pipeline programs within the Sterile Drug Product Commercialization group. This senior-level position involves executing and overseeing process characterization, scale-up, transfer, and validation activities for late-stage biologics projects. The incumbent will lead cross-functional working groups, manage drug product activities through filing and Process Performance Qualification (PPQ), and ensure compliance with scientific, quality, reliability, schedule, and cost requirements. Key responsibilities include developing robust commercialization strategies, mentoring team members, and driving continuous process optimization towards standardized platforms for various product presentations. The role requires expertise in sterile drug product fill finish processes, technology transfer, and scale-up to pilot/commercial scales, along with a strong background in chemical or biochemical engineering, biochemistry, or related fields. Candidates should possess experience in biologics commercialization, GMP compliance, and regulatory requirements, as well as proficiency in statistical methods and digital applications for manufacturing processes.

Skills

Biologics Drug Product Manufacturing Process Characterization Technology Transfer GMP DOE Design Data Analytics Computer Modeling Digital Applications Multivariate Analysis ICH Quality Norms Statistical Process Control PAT Techniques Fill Finish Operations PPQ Readiness Pre-Approval Inspection

What you'll do

  • Executes and oversees biologics product design, development, characterization, technology transfer, and robust commercial validation.
  • Leads cross-functional working groups for drug product activities through filing and Process Performance Qualification (PPQ).
  • Ensures commercialization programs meet science, quality, reliability, schedule, and cost requirements.
  • Innovates best practices for tech transfer, facility fit, and DP control strategy at commercial sites.
  • Develops and executes DP development and commercialization studies, including process validation at commercial scales.

What we're looking for

  • PhD in a relevant field with 8+ years of experience or equivalent.
  • Expertise in biologics drug product process development and optimization.
  • Experience with large-scale biologics manufacturing and fill-finish operations.
  • Proven track record in late-stage commercialization of biologics programs.
  • Strong knowledge of GMPs, ICH Quality norms, and regulatory requirements.
  • Proficiency in statistical methods for data analysis and process control.
  • Excellent communication skills for multi-disciplinary team environments.

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