Associate Principal Scientist, Sterile Product Development

Job Summary

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.

• Lead or contribute to 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 and regulatory documentation.
• Take active strategic and technical leadership on program development teams, interface with key stakeholders, and collaborate across functions to drive defined milestones.
• Lead and champion organizational strategic and innovation objectives aligned with organizational goals.
• Be willing to take initiative, motivate to excel, demonstrate a strong technical background, communicate effectively, multitask, mentor scientists, and foster a strong desire to learn and contribute.
• Lead project activities at external manufacturing sites including technology transfers.
• Enhance the company’s professional image and competitive advantage through patents, presentations, publications, and professional activities; advance areas such as science and technology development, strategic improvements, and process innovations.
• Maintain awareness of relevant new and current technologies, capabilities, and share this knowledge with others.

Minimum requirement:
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 4 years relevant industry experience. Alternative: B.S. or M.S. degree in Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 8 years relevant industrial experience.

• 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 knowledge in multiple areas, including core understanding of the drug development process.
• Track record of working effectively with team members of varied 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, and characterization reflected through industry experience and external publications or patents.

• 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.
• 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…