Associate Principal Scientist, Sterile Product Development

Associate Principal Scientist – Mixed Modalities, Sterile Product Development. Our Mixed Modalities team develops parenteral dosage forms across a broad range of modalities, translating preclinical candidates into commercial products. The Associate Principal Scientist leads and contributes to innovative biologics sterile product development, driving experimental design, data analysis, and regulatory support. Responsibilities Lead or contribute to new, innovative approaches for biologics sterile product development through generation and execution of experimental designs. Support early and late‑stage development candidates, including robust drug product composition, scalable process development, primary packaging selection, compatibility characterization, and regulatory filing preparation. Build deep fundamental knowledge of the drug product to ensure completion of key milestones and laboratory/regulatory documentation. Provide strategic and technical leadership on program development teams, interfacing with stakeholders and collaborating across functions to drive defined milestones. Champion organizational strategic and innovation objectives aligned with company goals. Lead and mentor project activities at external manufacturing sites, including tech transfer. Enhance professional image through patents, presentations, publications, and professional activities. Maintain awareness of relevant new and current technologies and share knowledge with the team. Qualifications Education Minimum: Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with ≥4 years relevant industry experience. Alternative: B.S. or M.S. in Engineering, Pharmaceutical Sciences or related discipline with ≥8 years relevant industrial experience. Required Experience & Skills Experience in biologics process development and characterization, particularly for late‑stage programs. Ability to lead formulation development activities in matrix team environments to define robust formulation and manufacturing processes. Recognized technical expert with proven ability to identify and develop innovative ideas. Broad knowledge of formulation science and in‑depth knowledge of multiple areas, including core understanding of the drug development process. Strong verbal and written communication skills. 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 & Skills Deep understanding of surface science, colloid science, particle engineering, and/or high‑concentration formulations. Prior experience leading enterprise‑level development projects. Ability to mentor individuals in a peer‑to‑peer and technical capacity. Subject‑matter expertise in at least one drug delivery and/or manufacturing technology. Demonstrated ability to identify, characterize, and address manufacturing challenges through development and optimization of novel production technologies. Experience with process scale‑up, modeling, regulatory filings, or capability evaluation/build. Salary & Benefits Salary range: $142,400.00 – $224,100.00. Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, healthcare and other insurance benefits (for employee and family), retirement benefits with 401(k), paid holidays, vacation, and compassionate and sick days. We are an Equal Employment Opportunity Employer. We 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. We comply with affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr MSD Malaysia