Associate Principal Scientist, Sterile Product Development

Job Description The Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms—including injections, implants, inhaled, and ocular products—for small, intermediate, and large molecules from preclinical toxicology studies through commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization so that the process is scalable without compromising stability, safety, efficacy, and delivery. We leverage smart experimental design, cutting‑edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection, enabling the translation of preclinical candidates into non‑oral drug products. Primary Duties Lead or contribute toward new, innovative approaches for biologics sterile product development through 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. Provide active strategic and technical leadership on program development teams, interfacing with key stakeholders and collaborating across functions to drive defined milestones. Lead and champion organizational strategic and innovation objectives aligned with company goals. Take initiative, be motivated to excel, demonstrate a strong technical background, excellent communication and interpersonal skills, ability to multi‑task, mentor scientists, and a strong desire to learn and contribute. Lead project activities at external manufacturing sites, including tech transfers. Enhance the company’s professional image and competitive advantage through patents, presentations, publications, and professional activities, and advance areas such as science and technology development, business process innovations, and technical improvements. Maintain awareness of relevant new and current technologies and effectively share this knowledge with others. Education Minimum Requirement Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 4 years of relevant industry experience. B.S. or M.S. degree in Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 8 years of 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. Broad knowledge of formulation science with in‑depth understanding in multiple areas, including core understanding of the drug development process. Track record of working effectively with team members of diverse skill sets and backgrounds. Strong verbal and written communication skills. Strong track record in product development, regulatory filing, drug delivery, complex formulation and process development/characterization reflected through industry experience and external publications or patents. 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. Capability to mentor individuals peer‑to‑peer and as a technical mentor. Recognized as a subject matter expert in at least one drug delivery or manufacturing technology. Demonstrated ability to both fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies. Desire to build new capabilities through 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 or build would be highly preferred. Equal Employment Opportunity 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. Salary and Benefits The salary range for this role is $142,400.00 – $224,100.00. A longitudinal compensation package may include annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, health care, mandatory mandatory self‑mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory #J-18808-Ljbffr Merck & Co.