Associate Principal Scientist, Engineering- Biologics, Sterile Drug Product Commercialization

MSD

Remote Actively hiring
West Point, USA · Remote Posted 14 days ago $142,400–$224,100 / year
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At a glance

AI generated

TL;DR

The Associate Principal Scientist role in Our Company’s Manufacturing Division focuses on advancing and commercializing biologics pipeline programs within the Sterile Drug Product Commercialization team. This senior-level position involves leading cross-functional working groups, managing drug product activities through filing and Process Performance Qualification (PPQ), ensuring compliance with scientific and regulatory standards, and driving strategic initiatives for efficient commercialization. Key responsibilities include process characterization, scale-up, technology transfer, and validation at commercial sites, as well as developing control strategies and influencing CMC regulatory submissions. The ideal candidate has extensive experience in biologics drug product development, manufacturing, and optimization, along with a strong background in sterile drug product fill finish processes and GMP compliance. Proficiency in statistical methods, data analytics, and digital applications is preferred, alongside expertise in biochemistry and biopharmaceuticals.

Skills

Biochemistry Biologics Biomedical Engineering Drug Product Manufacturing Manufacturing Processes Process Validation Technology Transfer cGMPs ICH Quality Norms DOE Design Statistical Process Control MVA PAT Techniques Data Analytics Computer Modeling 3-D Printing Immunochemistry Protein Purifications Regulatory Submissions

What you'll do

  • Leads and manages biologics drug product activities through filing and Process Performance Qualification.
  • Ensures commercialization programs meet scientific, quality, reliability, schedule, and cost requirements.
  • Develops process and product development plans, influencing primary packaging and combination product design decisions.
  • Designs and executes drug product development and commercialization studies at various scales.
  • Innovates best practices for tech transfer, facility fit, and DP control strategy in sterile product commercialization.

What we're looking for

  • B.S. or higher in relevant field with extensive experience in biologics drug product development.
  • Proven expertise in sterile drug product fill finish processes for large molecules.
  • Experience in technology transfer and scale-up of biologics to pilot/commercial scales.
  • Strong knowledge of regulatory requirements, cGMPs, and ICH Quality norms for sterile products.
  • Excellent communication skills for multi-disciplinary team environments.
  • Background in process optimization, validation, and control strategy development.
  • Familiarity with statistical methods and digital applications in manufacturing processes.

Market check

Salary context

This $142,400–$224,100 range sits above 41% of similar postings on FindRole.

Peer median band

$153,139–$238,600

Median floor and ceiling across peers.

Typical midpoint (25–75%)

$162,000–$244,250

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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