Associate Principal Scientist, Vaccine Drug Product Commercialization

MSD

Remote Actively hiring
Remote, USA · West Point, PA Posted 16 days ago $142,400–$224,100 / year
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At a glance

AI generated

TL;DR

The Associate Principal Scientist role in the Vaccine Sterile Drug Product Commercialization team within our manufacturing division requires an experienced professional to lead and support late-stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceuticals. This position involves driving process characterization, scale-up, transfer, and validation activities while collaborating with cross-functional teams to ensure alignment between development programs and manufacturing capabilities. Day-to-day responsibilities include executing DP development studies, authoring regulatory submissions, and providing mentorship to team members. The ideal candidate should have a background in chemical engineering or related fields, extensive experience in drug product process development, and knowledge of cGMPs and ICH Quality norms. Proficiency with analytical methods for vaccine characterization, technology transfer, and scale-up processes is essential, along with strong communication skills to navigate complex technical environments effectively.

Skills

cGMPs ICH Quality Norms Drug Product Process Development Process Characterization Analytical Methods Sterile Drug Product Manufacturing Fill-Finish Operations Technology Transfer Scale-Up Processes Data Analytics Statistical Process Control MVA PAT Techniques Biochemistry Microbiology Biopharmaceuticals Machine Learning Deep Learning

What you'll do

  • Lead DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution.
  • Design and execute drug product development and commercialization studies, new product introduction, and process validation at commercial sites.
  • Ensure fit-for-purpose scale-down models are developed for sterile products and validate platform engineering and scientific models.
  • Influence CMC regulatory strategy and author DP CMC sections of filing documents for agency meetings.
  • Drive continuous process optimization towards standardized platforms for various product presentations.

What we're looking for

  • B.S. or higher in relevant field with 4+ years of experience in drug product development and commercialization.
  • Experience with vaccine modalities such as conjugates, LVV, VLP, subunit, adjuvants.
  • Understanding of cGMPs for sterile dosage forms and ICH Quality norms.
  • Expertise in sterile drug product fill-finish manufacturing processes at pilot/commercial scales.
  • Technical knowledge in process characterization, scale-up, and technology transfer.
  • Strong oral and written communication skills to articulate complex technical concepts.
  • Experience with regulatory requirements for commercializing sterile drug products.

Market check

Salary context

This $142,400–$224,100 range sits above 46% of similar postings on FindRole.

Peer median band

$142,360–$234,250

Median floor and ceiling across peers.

Typical midpoint (25–75%)

$162,000–$231,625

Middle half of comparable postings.

Based on 240 comparable postings.

* 240 is the maximum number of comparable postings sampled.

Employer

About MSD

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

MSD currently has 4 open roles on FindRole.

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