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Msat Drug Product Development information

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$42.5K

$127K

$144.5K

How much do msat drug product development jobs pay per year?

As of Jun 16, 2026, the average yearly pay for msat drug product development in the United States is $126,987.00, according to ZipRecruiter salary data. Most workers in this role earn between $114,500.00 and $143,000.00 per year, depending on experience, location, and employer.

What are some common challenges faced by professionals in MSAT Drug Product Development, and how can they be addressed?

Professionals in MSAT Drug Product Development often encounter challenges such as scaling up manufacturing processes, ensuring product quality, and meeting regulatory requirements under tight timelines. These issues can be addressed by fostering close collaboration between R&D, quality assurance, and manufacturing teams, as well as implementing robust process monitoring and data analysis techniques. Continual learning and staying updated with regulatory changes also help teams proactively manage risks and maintain compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive in MSAT Drug Product Development, and why are they important?

To excel in MSAT (Manufacturing Science and Technology) Drug Product Development, you need a solid background in pharmaceutical sciences, chemical engineering, or related fields, often supported by an advanced degree. Familiarity with process analytical technology, quality by design (QbD), and regulatory compliance systems such as GMP is essential. Strong problem-solving, project management, and cross-functional communication skills help you navigate complex technical challenges and collaborate effectively. These competencies ensure the successful development, scale-up, and transfer of robust drug manufacturing processes while meeting regulatory and quality standards.

What is the difference between Msat Drug Product Development vs Formulation Scientist?

AspectMsat Drug Product DevelopmentFormulation Scientist
Required CredentialsBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields; experience in drug developmentBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields; focus on formulation techniques
Work EnvironmentResearch labs, development teams, cross-functional collaborationLaboratories, formulation labs, research and development settings
Industry UsagePharmaceutical companies, biotech firms, contract research organizationsPharmaceutical companies, research institutions, biotech firms

Msat Drug Product Development and Formulation Scientist roles share similar educational backgrounds and work environments. However, Msat Drug Product Development typically involves overseeing the entire drug development process, including formulation, stability, and manufacturing considerations, while Formulation Scientists focus primarily on creating and optimizing drug formulations. Both roles are essential in bringing new drugs to market, with Msat Drug Product Development often having broader responsibilities across the product lifecycle.

What is MSAT Drug Product Development?

MSAT Drug Product Development refers to the role of Manufacturing Science and Technology (MSAT) professionals who focus on the development and optimization of drug products. These experts bridge the gap between research and commercial manufacturing by scaling up processes, ensuring quality, and implementing best practices in production. They collaborate with R&D, quality assurance, and manufacturing teams to improve product formulations, troubleshoot production issues, and ensure regulatory compliance throughout the drug product lifecycle.

Senior Principal Engineer/Associate Director, Drug Product MSAT

Summit Therapeutics

Princeton, NJ • On-site

Other

Posted 17 days ago

Job description

Overview of Role:

We are seeking a highly experienced and strategic Senior Principal Engineer/Associate Director of MSAT - Drug Product to join the CMC team and be a key contributor to ongoing process development, technology transfer, process validation, BLA/MAA/IND/IMPD authoring and readiness, and agency interaction activities, in preparation for commercialization and incremental clinical/commercial batch production of our main asset. This role will focus on leading DP Tech transfer(s), authoring technical reports and on providing content to the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. The ideal candidate will bring significant experience in biologics manufacturing, sterile drug product operations, and regulatory expectations.  

Role and Responsibilities:

  • Provide technical expertise for phase-appropriate drug product process development, characterization, validation, and technology transfer for sterile drug product (DP). 
  • Assess and manage process risks arising from manufacturing or process changes. 
  • Serve as a primary or supporting technical interface with external CDMOs and internal manufacturing teams.  
  • Lead or significantly contribute to implementation of process, product, and site changes across the product lifecycle.  
  • Support and guide execution of clinical and commercial batch manufacturing activities to meet development and supply timelines.  
  • Assist in the authorship, data verification, update, and/or review of regulatory filings. 
  • Provide technical feedback during regulatory agency inquiries.  
  • Lead PPQ execution and manufacturing oversight in alignment with GMP and quality system requirements through person in plant.  
  • Collaborate closely with Regulatory, Quality, Supply Chain, and other CMC functions to ensure integrated planning and execution.  
  • Ensure GMP compliance across all assigned activities.  
  • Support audits, inspections, and continuous improvement initiatives.  
  • Manage process deviation investigations and change controls. 
  • Travel as needed to support technology transfer, process scale-up, and collaboration with external partners. 
  • All other duties as assigned


Experience, Education and Specialized Knowledge and Skills:

  • Bachelor's degree in chemical engineering, biotechnology, pharmaceutical science, or a related field required. Advanced degree (Masters or PhD) preferred. 
  • Minimum of 10+ years of relevant experience within the life sciences industry  
  • Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturing with a focus on sterile drug product and late-phase development (preferably mAbs)is essential.  
  • Experience with technology transfer across different systems, scales, and sites is highly valued 
  • Experience in late-stage process development, characterization and validation is highly valued 
  • IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution highly preferred 
  • Data Analytics experience including JMP and other data organization (AI-based or not) platforms a strong plus 
  • Strong communication, management, and interpersonal skills to effectively influence across the organization and with CDMOs/CMOs. 
  • Excellent attention to detail and organizational skills, with a focus on quality and technical excellence. 
  • Good information management and data organization skills 
  • Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators. 
  • A track record of working under pressure and delivering high-quality results to tight deadlines. 

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