Process Engineer, Upstream Process Characterization & Commercialization

We are seeking a highly motivated Engineer to support upstream process characterization and commercialization activities for viral vector programs. In this role, you will contribute to late-stage development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to internal and external manufacturing sites. This position focuses specifically on upstream unit operations, including shake flask and bioreactor-based cell culture, transient transfection, cell expansion, harvest operations, and scale‑up across development and commercial platforms (including Amber systems). The ideal candidate has strong hands‑on experience in upstream viral vector manufacturing, transient transfection-based processes, and can provide on‑the‑floor technical leadership during engineering, PPQ, and commercial campaigns. Key Responsibilities Upstream Process Characterization & Validation Design, execute, and support upstream process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments). Develop and execute characterization strategies to define CPP–CQA linkages for upstream unit operations. Perform data analysis, technical report authorship, and presentation of study outcomes to cross‑functional teams and governance forums. Support development and refinement of control strategies for upstream processes, including raw materials, transfection reagents, cell banks, and process parameters. Conduct batch record review, deviation assessment, and data trending to ensure robustness of upstream manufacturing processes. Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding. PPQ, Tech Transfer & Manufacturing Readiness Contribute to PPQ planning, readiness, execution, and documentation for upstream processes. Support technology transfer of upstream processes to internal manufacturing sites and CDMOs, including fit‑for‑purpose assessments and scale translation. Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required). Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms. Regulatory Support Contribute to authoring and review of CMC documentation, including upstream process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements. Support preparation of BLA/MAA submissions and responses to regulatory questions related to upstream manufacturing. Cross‑Functional Collaboration Work closely with downstream, analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment. Represent upstream characterization activities in technical meetings, reviews, and governance discussions. Support lifecycle management, post‑approval changes, and continuous improvement initiatives for upstream processes. Required Qualifications Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands‑on industry experience. Hands‑on experience with upstream viral vector manufacturing, including transient transfection‑based processes. Experience with shake flask, bench‑scale, pilot‑scale, and commercial bioreactor systems; experience with Amber systems strongly preferred. Experience with late‑stage development, process characterization, and PPQ principles for upstream processes. Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation. Experience working in GMP environments, including batch record execution or review, deviations, and investigations. Strong technical writing, data analysis, and problem‑solving skills. Preferred Qualifications Experience supporting late‑stage viral vector programs (lentiviral, AAV, adenoviral, VLPs). Experience designing and executing DOE and multivariate data analysis for upstream processes. Experience contributing to BLA/MAA submissions or regulatory interactions. Knowledge of control strategy development and risk assessment tools (e.g., FMEA). Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development. Key Competencies Strong experimental design and execution skills. Excellent cross‑functional communication and collaboration. Ability to operate effectively in fast‑paced, late‑stage development environments. Scientific curiosity, ownership mindset, and willingness to support manufacturing operations. The annual base pay for this position ranges from $ 76,308.00 - $114,462.00 . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 15-Jan-2026 Closing Date 21-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.