Merck · 18 hours ago
Principal Scientist, Vaccine Drug Product Development
Merck is a leading company in the development of novel vaccines and is seeking a Principal Scientist in Vaccine Drug Product Development at their West Point, PA location. The role involves leading a team in the design and execution of experiments to develop stable formulations and robust manufacturing processes for vaccine products, while ensuring effective communication and collaboration across various functional areas.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
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
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
Preferred
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
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital Advisors"Gavi, the Vaccine Alliance"
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Recent News
2026-02-05
Genetic Engineering News
2026-02-05
Company data provided by crunchbase