Principal Scientist, Engineering

Job Summary Principal Scientist, Biologics, Sterile Drug Product Commercialization. As part of the Manufacturing Division, the Sterile Drug Product Commercialization group leads technical process development and laboratory capabilities for late‑stage and commercial biologics drug product processes. The role focuses on driving excellence in process characterization, scale‑up, transfer, and validation for the commercialization of biologics and combination products. Responsibilities Execute and provide oversight to biologics product and process design, development, characterization, technology transfer, and robust commercial validation. Lead or serve on cross‑functional drug product working groups, managing activities through filing, Process Performance Qualification (PPQ), registration stability studies, tech transfer strategy, PPQ readiness, Pre‑Approval Inspection (PAI) readiness, approval, launch, and post‑launch support. Ensure commercialization programs meet science, quality, reliability, schedule, and cost requirements. Drive strategic initiatives in the department and with partner groups to enable more efficient and rapid commercialization of innovative products. Provide mentorship, technical oversight, and strategic guidance to employees; use advanced experience to address non‑routine issues. Develop a process and product development plan and influence decisions related to primary packaging and combination product design. Design and execute drug product development and commercialization studies, new product introduction, and process validation at commercial sites. Ensure fit‑for‑purpose scale‑down models are developed and employed. Establish and validate platform engineering and scientific models for sterile product and process commercialization. Innovate and drive best practices for commercial site tech transfer, facility fit, and development of the drug product control strategy. Classify process parameters, performance parameters, operating ranges, and in‑process controls. Drive and influence process demonstration and qualification (PPQ) and shelf‑life strategies. Influence CMC regulatory strategy, review regulatory strategy and filing readiness, and support agency meeting preparations. Author and review regulatory submissions. Drive continuous and phase‑appropriate process optimization toward standardized platforms for liquid, lyophilized, and combination product presentations. Establish and foster a culture of high performance, out‑of‑the‑box thinking, innovation, learning, empowerment, diversity, and inclusion. Education Minimum Requirements B.S. in Chemical Engineering, Biochemical Engineering, Bio‑engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience. Master's degree in the same fields with 10 years of relevant experience. Ph.D. in the same fields with 8 years of relevant experience. Required Experience and Skills Experience with drug product process development, optimization, and/or process characterization of biologics (mAbs, ADCs, fusion proteins). Experience with at‑scale biologics drug product manufacturing and fill‑finish operations. Experience with late‑stage commercialization of biologics programs. Technical expertise in sterile drug product fill‑finish manufacturing processes for large molecules, including laboratory or fundamental models for key unit operations. Experience with technology transfer and scale‑up of processes to pilot and/or manufacturing scales. Excellent oral and written communication skills; ability to articulate process science for decision making in a multi‑disciplinary team. Preferred Experience and Skills Biologics drug product fill‑finish process optimization, scale‑up, and technology transfer of sterile products to pilot/commercial operations. Experience in manufacturing potently sterile drug products at pilot and/or commercial scale. Experience with commercialization of biologics programs through PPQ and launch. Working knowledge of analytical methods and product attributes for biologics. Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including Quality by Design principles. Knowledge of cGMPs for manufacturing sterile dosage forms and ICH quality norms. Statistical methods for DOE design, data analysis, SPC, MVA, and PAT techniques. Experience in data analytics, computer modeling, and digital applications. Understanding of analytical methods to characterize biologics and other sterile drug products. Travel This position may require travel up to 25% and requires the ability to travel as needed. Salary & Benefits Salary range: $173,200.00 – $272,600.00. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, other insurance coverage for employee and family, 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 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. 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 the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights and EEOC GINA Supplement. #J-18808-Ljbffr