Associate Principal Scientist, Vaccine Drug Product Development

4 days ago


West Point, Mississippi, United States Merck Sharp & Dohme Full time
Job Description

Vaccine Drug Product Development (VDPD) at Merck Sharp & Dohme is seeking an Associate Principal Scientist to join our team in West Point, PA. Our mission is to develop novel vaccine drug products that will profoundly improve global human health.

Key Responsibilities
  • Design, execute, and document experiments to develop stable formulations and robust manufacturing processes for preclinical and clinical supply production.
  • Scale-up these processes to the pilot plant and commercial space.
  • Lead matrix teams and manage expectations of stakeholders as part of our stage-gate process used to manage the development of new products.
  • Support or lead teams to advance areas such as science and technology innovation, business process improvement, and clinical manufacturing capability build.
Requirements
  • Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with 4 years of relevant industrial experience.
  • Proven written and verbal communication skills.
  • Ability to prioritize, plan, and execute work with limited guidance.
  • Ability to work in a dynamic and fast-paced team environment.
  • Demonstrated facilitative leadership and influencing skills.
  • Hands-on laboratory skills.
  • Experience developing vaccine adjuvant and/or vaccine drug product processes, including advanced knowledge of key unit operations.
  • Understanding of vaccine adjuvant and/or drug product quality attributes, specifications, characterization techniques, and product vulnerabilities and mitigation strategies.
Desirable Skills
  • Experience with sterile product manufacturing and aseptic technique.
  • Experience with colloidal systems and characterization of colloids including emulsions.
  • Familiar with ISO, CFR, ICH, and USP guidelines as they relate to sterile products.
  • Familiar with Quality by Design (QbD) principles and have experience applying the QbD tools and principles to products in development.
  • Experience with process modeling.
  • Experience with liquid and lyophilized drug product formulation development.
  • Understanding of compliance and regulatory issues for sterile injectable products manufactured by aseptic processing.


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