Associate Principal Scientist, Sterile Product Development

Overview The Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection. In summary, our team enables the translation of preclinical candidates into non‑oral drug products. Responsibilities Lead/ contribute towards the new, innovative approaches for biologics sterile product development through the generation of experimental designs, execution of experimental plans and data analysis Support both early and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory documentation. Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required. Responsible for leading and championing organizational strategic and innovation objectives aligned with organizational goals. Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute. Leads project activities at external manufacturing sites including tech transfers. Enhance our Company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations. Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others. Education Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant industry experience. B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience. Required Experience and Skills Experienced in biologics process development and characterization particularly for late‑stage programs. Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process. Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas. Has broad knowledge of formulation science and in depth‑knowledge in multiple areas, including core understanding of the drug development process. Track record of working effectively with team-members of skill sets and backgrounds. Strong verbal and written communication skills. The candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and process development/ characterization reflected through industry experience and external publications/ patent. Antibody Drug Conjugates (ADC), Biomedical Engineering, Cell Line Development, Competitive Advantages, Detail‑Oriented, Development Projects, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Interpersonal Relationships, Leading Project Teams, Molecular Biology, Multitasking, Particle Physics, Peer Mentoring, Pharmaceutical Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Pharmaceutical Sciences, Physical Characterization, Process Scale Up, Stable Cell Lines, Stakeholder Engagement. Preferred Experience and Skills Deep understanding of one or more of the following: surface science, colloid science, particle engineering and/or high concentration formulations. Prior experience leading development projects at an enterprise level. Capable of mentoring individuals in a peer‑to‑peer fashion and as a technical mentor. Recognized as a subject matter expert in at least one drug delivery and/or manufacturing technology. Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies. Desire to build new capabilities through the evaluation of new technologies and hands‑on optimization of existing technologies. Prior experience with process scale up, modeling, regulatory filings and/or driving key capability evaluation/ build would be highly preferred. Compensation and Benefits The salary range for this role is $142,400.00 – $224,100.00. 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. 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 Employment Information Employee Status: Regular. Relocation: Domestic. VISA Sponsorship: Yes. Travel Requirements: 10%. Flexible Work Arrangements: Not Applicable. Shift: Not Indicated. Valid Driving License: No. Hazardous Material(s): n/a. Equal Employment Opportunity Statement 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 the EEOC Know Your Rights and 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. #J-18808-Ljbffr Merck & Co.