Associate Principal Scientist, Sterile Product Development

Job Description The Sterile Product Development (SPD) group is responsible for developing non‑oral 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 so 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. Primary Duties 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 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 organizational goals Take initiative, be motivated to excel, possess a strong technical background, excellent communication and interpersonal skills, ability to multitask, mentor other scientists, and 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 and advance areas such as science and technology development, technical and business strategic improvements, and business process innovations Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others Education Minimum Requirement Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or a related discipline with a minimum of 4 years relevant industry experience B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or a related discipline with a minimum of 8 years relevant industrial experience Required Experience and Skills Experience in biologics process development and characterization, particularly for late‑stage programs Capacity to lead 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 and 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 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 in a peer‑to‑peer fashion and as a technical mentor Recognition 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 or build Required Skills Biologics, Cross‑Functional Leadership, Downstream Process Development, Drug Delivery Technology, Drug Development, Drug Formulations, Formulation Chemistry, Formulation Development, Molecular Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Pharmaceutical Sciences, Physical Characterization, Regulatory Filings, Stakeholder Engagement, Sterile Manufacturing, Sterile Products, Strategic Planning Preferred Skills Colloid Science, Particle Engineering, Surface Science Benefits 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. Salary The salary range for this role is $142,400.00 – $224,100.00. Additional Information Location: US and Puerto Rico Residents Only San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in accordance with applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Employee status: Regular Relocation: Domestic Visa sponsorship: Yes Travel requirements: 25% Job posting end date: 05/27/2026 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 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 U.S. Equal Opportunity Employment laws, references include EEOC Know Your Rights, EEOC GINA Supplement and related public‑access resources. #J-18808-Ljbffr EyeBio