Associate Principal Scientist, Engineering

Associate Principal Scientist, Biologics, Sterile Drug Product Commercialization Lead and advance the commercialization of biologics and combination products within the Sterile Drug Product Commercialization group of our Manufacturing Division. Provide technical process leadership, laboratory capabilities, and drive innovation for late-stage product development, scale‑up, technology transfer, process validation, regulatory submissions, and manufacturing investigations. Responsibilities Lead and/or serve on cross‑functional biologics drug product (DP) working groups and manage DP activities through filing, Process Performance Qualification (PPQ), and process characterization. Ensure commercialization programs meet science, quality, reliability, schedule, and cost requirements. Drive strategic technical and business initiatives to accelerate commercialization of innovative products. Provide mentorship, technical oversight, and strategic guidance to employees. Use advanced scientific expertise to guide resolution of non‑routine and difficult issues. Develop process and product development plans and influence decisions on primary packaging and combination product design. Design and execute DP development and commercialization studies, new product introduction, and process validation at commercial sites. Develop and employ fit‑for‑purpose scale‑down models. Establish and validate platform engineering and scientific models for sterile product and process commercialization. Innovate and promote best practices for commercial site tech transfer, facility fit, and DP control strategy development. Drive and influence process demonstration, qualification (PPQ), and shelf‑life strategies. Influence CMC regulatory strategy and manage DP CMC sections of filings. Review regulatory strategy, ensure filing readiness, and support agency meeting preparations. Author and review regulatory submissions. Drive continuous, phase‑appropriate process optimization toward standardized platforms for liquid, lyophilized, and combination product presentations. Travel Up to 25% travel required. Qualifications Education B.S. in Chemical Engineering, Biochemical Engineering, Bio‑engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience. M.S. in the same fields with 8 years of relevant experience. Ph.D. in the same fields with 4 years of relevant experience. Experience & Skills Experience with drug product process development, optimization, and/or characterization of biologics. Experience with large‑molecule biologics drug product manufacturing, fill‑finish operations, and laboratory/fundamental models. Technology transfer and scale‑up experience to pilot and/or commercial scales. Strong oral and written communication skills and ability to articulate process science in multidisciplinary teams. Preferred: experience with biologics drug product fill‑finish process optimization, scale‑up, and technology transfer of sterile products to pilot/commercial operations. Operations experience in manufacturing potent and sterile drug products at pilot and/or commercial scale. Late‑stage commercialization experience of biologics programs. Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including Quality by Design principles. Knowledge of GMP, ICH quality norms, statistical methods for DOE, SPC, MVA, PAT, data analytics, computer modeling, and digital applications. Proficiency in analytical methods for characterizing biologics and other sterile drug products. Core competencies: adaptability, bioprocessing, data analysis, decision making, detail orientation, supervision, process validation, quality control, scale‑up, mentorship, regulatory submissions, technical writing, technology transfer. Benefits Medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days. EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with all affirmative action requirements as a federal contractor. #J-18808-Ljbffr