Principal Scientist, Vaccine Drug Product Development

Vaccine Drug Product Development (VDPD), 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.

About the role

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

• 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 collaborating 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.
• Demonstrate facilitative leadership and communication skills to effectively lead matrix teams and manage stakeholder expectations as part of our stage-gate process for new product development.
• Lead teams to advance science and technology innovation, business process improvement, and clinical manufacturing capability build.
• Actively mentor less experienced scientists.
• Maintain strong external scientific networks to stay aware of industry challenges, trends, and opportunities.
• Publish externally, patent innovations, and present findings.

Requirements

• Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with a minimum of 8 years of relevant industrial experience; OR an M.S. degree in a similar field with a minimum of 10 years of relevant industrial experience; OR a B.S. degree in a similar field with a 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 the 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 drug product).
• 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.

Qualifications

• Experience with sterile product manufacturing and aseptic technique.
• Experience with colloidal systems and characterization of colloids including emulsions.
• Familiarity with ISO, CFR, ICH, and USP guidelines as they relate to sterile products.
• Familiarity with Quality by Design principles and experience applying these tools 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.

Pay

The salary range for this role is $173,200.00 - $272,600.00. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• 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.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Schedule

• Travel Requirements: 10%
• Relocation: Domestic
• VISA Sponsorship: Yes