About the position
Vaccine Drug Product Development (VDPD), a part of our company's Research Laboratories, is seeking a Senior Scientist to join our department in West Point, PA. Our mission is to develop novel vaccine drug products that will profoundly improve global human health—directly building from our company's 50+ year legacy as pioneers in the discovery, development, and manufacturing of novel vaccines to eliminate disease. Our department is responsible for developing vaccine adjuvant systems and complex drug products from preclinical studies through Phase III clinical trials with line of sight to commercialization. We ensure robust composition, primary packaging, and process development through deep fundamental understanding and characterization such that the process is scalable without compromising safety, efficacy, or stability. During development, we leverage smart experimental design, cutting edge analytical tools, and statistical/predictive approaches to inform formulation and process development. Our team enables the translation of vaccine preclinical candidates from concepts into robust commercial drug products.
Responsibilities
- Design, execution, and documentation of experiments to develop stable formulations and robust manufacturing processes for preclinical and clinical supply production.
- Scale-up processes to the pilot plant and commercial space.
- Work independently in a hands-on, dynamic laboratory environment engaged in development activities.
- Collaborate 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 through verbal, written documents, and technical presentations.
- 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 chemistry, biochemistry, pharmaceutical sciences, chemical/biochemical engineering or related discipline (with expected completion by August 2025) with 0+ years of relevant industrial or post-doctoral experience.
- M.S. degree in a similar field with 4+ years of relevant industry experience.
- B.S. degree in a similar field with 6+ years of relevant industry experience.
- Experiences in chemical and biochemical research including analytical characterization.
- Experience developing, characterizing and stabilizing protein-based biotherapeutic formulations, vaccine adjuvant and/or vaccine drug products.
- Familiar with 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.
- Track record of difficult technical problem solving and solutioning.
- Ability to develop and implement new methods/processes.
- Familiar with use of statistical principles to understand, predict, and communicate process robustness.
- Familiar with root cause analysis and investigations (FMEA, fishbone, etc.).
- Experience, desire, and a track record of effective mentorship of less experienced scientists towards timebound goals.
- 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.
Nice-to-haves
- Experience with technical transfer of processes from lab to pilot plant and/or commercial sites including the use of risk assessment tools.
- Experience with GMP manufacturing of clinical supplies.
- Experience with sterile product manufacturing and aseptic technique.
- Experience with colloidal systems and analytical characterization of colloids including emulsions and suspension based formulations.
- 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 liquid and lyophilized drug product formulation development.
- Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or DP).
- Understanding of compliance and regulatory issues for sterile injectable products manufactured by aseptic processing.
Benefits
- Medical, dental, vision healthcare and other insurance benefits (for employee and family).
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
