Associate Principal Scientist, Vaccine Drug Product Development

Job description

Job Description Vaccine Drug Product Development, a part of our company's Research Laboratories, is seeking an Associate 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: 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 support 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 supporting or 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. Successful candidates will have a track record of external publication, patenting, and presentations. Required Experience and Skills: Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with minimum of 6 years of relevant industrial experience; an M.S. degree in a similar field with minimum of 8 years of relevant industrial experience; or a B.S. degree in a similar field with minimum of 10 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, vaccine drug product, and/or biologics drug product processes including advanced knowledge of key unit operations (freeze/thaw, formulation, mixing, filtration, filling, stoppering, etc.) Understanding of sterile drug product quality attributes, specifications, characterization techniques, and product vulnerabilities and mitigation strategies Track record of difficult technical problem solving Ability to develop and implement new methods/processes Experience with use of statistical principles to understand, predict, and communicate process robustness Experience 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 Desired Experience and Skills: Experience with sterile product manufacturing and aseptic technique, and experience with GMP manufacturing of clinical supplies Experience with technical transfer of processes from lab to pilot plant and/or commercial sites including the use of risk assessment tools Experience with engineering principles used in process development and process scale up/scale down 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 liquid and lyophilized drug product formulation development Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or DP), and experience responding to regulatory questions related to drug products #erp #PSCS #VDPD Required Skills: Biochemistry, Cell Line Development, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Facilitative Leadership, GMP Compliance, Interpersonal Relationships, Leading Project Teams, Mentorship, Molecular Biology, New Product Development, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Process Scale Up, Risk Analysis, Risk Assessments, Stable Cell Lines Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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. We offer a comprehensive package of benefits. Available benefits include 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. You can apply for this role through