Principal Scientist, Vaccine Drug Product Development

Role Summary

Principal Scientist, Vaccine Drug Product Development in West Point, PA. Lead the development of vaccine adjuvants and drug products from preclinical studies through Phase III trials, ensuring robust formulation, packaging, and scalable processes that preserve safety, efficacy, and stability. Drive cross-functional collaboration, use advanced analytics and design of experiments to inform formulation and process development, and translate vaccine concepts into robust commercial drug products.

• Lead a matrixed team in the design, execution, and documentation of experiments to develop stable formulations and robust manufacturing processes for preclinical and clinical supply production and to scale-up these processes to the pilot plant and commercial space.
• The successful candidate will be expected to work independently in a hands-on, dynamic laboratory environment engaged in development activities while also working collaboratively within the group, across functional areas, and with external partners.
• Active strategic and technical leadership on program development teams will be required.
• Strong communication skills are expected to clearly communicate data and conclusions verbally, through written documents and reports, and technical presentations.
• Proven facilitative leadership and communication skills are essential to effectively lead matrix teams and manage expectations of stakeholders as part of our stage-gate process used to manage the development of new products.
• The role will also entail leading teams to advance areas such as science and technology innovation, business process improvement, and clinical manufacturing capability build.
• Successful candidates are motivated to excel, willing to take initiative, have a strong desire to learn and contribute, and actively mentor less experienced scientists.
• Senior colleagues in Vaccine Drug Product Development have strong external scientific networks to help us maintain an awareness of industry challenges, trends, and opportunities.
• Successful candidates will have a track record of external publication, patenting, and presentations.

• Required:
  
  Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with minimum of 8 years of relevant industrial experience; an M.S. degree in a similar field with minimum of 10 years of relevant industrial experience; or a B.S. degree in a similar field with minimum of 12 years of relevant industrial experience.
• Required:
  
  Proven written and verbal communication skills
• Required:
  
  Ability to prioritize, plan, and execute work with limited guidance
• Required:
  
  Ability to work in a dynamic and fast-paced team environment
• Required:
  
  Demonstrated facilitative leadership and influencing skills
• Required:
  
  Hands on laboratory skills
• Required:
  
  Experience developing vaccine adjuvant and/or vaccine drug product processes, or significant nucleic acid and lipid nanoparticle experience, including advanced knowledge of key unit operations (freeze/thaw, formulation, mixing, filtration, filling, stoppering, etc.)
• Required:
  
  Understanding of vaccine adjuvant and/or drug product quality attributes, specifications, characterization techniques, and product vulnerabilities and mitigation strategies
• Required:
  
  Experience with engineering principles used in process development and process scale up/scale down
• Required:
  
  Experience with technical transfer of processes from lab to pilot plant and/or commercial sites including the use of risk assessment tools
• Required:
  
  Track record of difficult technical problem solving
• Required:
  
  Ability to develop and implement new methods/processes
• Required:
  
  Experience with GMP manufacturing of clinical supplies
• Required:
  
  Experience with use of statistical principles to understand, predict, and communicate process robustness
• Required:
  
  Experience with root cause analysis and investigations (FMEA, fishbone, etc.)
• Required:
  
  Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or DP)
• Required:
  
  Experience responding to regulatory questions related to drug products
• Required:
  
  Experience, desire, and a track record of effective mentorship of…