Principal Scientist – Vaccine Drug Product Development
| Company | MSD |
|---|---|
| Location | North Wales, PA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with 8 years of relevant industrial experience; an M.S. degree in a similar field with 10 years of relevant experience; or a B.S. degree in a similar field with 12 years of relevant 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, or significant nucleic acid and lipid nanoparticle experience, including advanced knowledge of key unit operations (freeze/thaw, formulation, mixing, filtration, filling, stoppering, etc.)
- Understanding of vaccine adjuvant and/or drug product quality attributes, specifications, characterization techniques, and product vulnerabilities and mitigation strategies
- Experience with engineering principles used in process development and process scale up/scale down
- Experience with technical transfer of processes from lab to pilot plant and/or commercial sites including the use of risk assessment tools
- Track record of difficult technical problem solving
- Ability to develop and implement new methods/processes
- Experience with GMP manufacturing of clinical supplies
- Experience with use of statistical principles to understand, predict, and communicate process robustness
- Experience with root cause analysis and investigations (FMEA, fishbone, etc.)
- Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or DP)
- Experience responding to regulatory questions related to drug products
- Experience, desire, and a track record of effective mentorship of less experienced scientists towards timebound goals.
Responsibilities
- 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.
- 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.
- Provide active strategic and technical leadership on program development teams.
- Communicate data and conclusions clearly, verbally, through written documents and reports, and technical presentations.
- Lead matrix teams and manage expectations of stakeholders as part of the 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.
Preferred Qualifications
- 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 principles and have experience applying the Quality by Design 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
- Experience with direct people management