Principal Scientist, Vaccine Drug Product Development

Merck•Upper Gwynedd Township, PA

25d•Hybrid

About The Position

Vaccine Drug Product Development, a part of our company's Research Laboratories, is seeking a Principal 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 adjuvants and 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. Primary Responsibilities: 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.

Requirements

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.
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

Nice To Haves

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

Responsibilities

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.
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.
Communicate data and conclusions verbally, through written documents and reports, and technical presentations.
Effectively lead matrix teams and manage expectations of stakeholders as part of our stage-gate process used to manage the development of new products.
Lead teams to advance areas such as science and technology innovation, business process improvement, and clinical manufacturing capability build.
Actively mentor less experienced scientists.