What you’ll do
You will be responsible for leading or participating in molecule support activities such as the following:
Lead Technology Transfer & Production support activities including: fit-to-plant, process risk analysis, timely generation of Chemistry Manufacturing and Controls documentation, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, and investigation support.
Serve as Drug Substance process Workstream Lead and/or general Technical Lead for both clinical and commercial projects at FMC.
Serves as mentor and positive role model to colleagues with occasional supervision of entry-level scientists or associates.
Broad understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to TT
Make detailed observations, analyze data using multivariate analysis (MVDA) software, and interpret results. Likewise, effectively present results at internal meetings and external scientific meetings.
Author/review technical reports and deliver presentations utilizing sound scientific reasoning and interpretation of the available data.
Provide solutions to a variety of problems of diverse scope involving basic scientific principles.
Collaborate with internal and external stakeholders including but not limited to Manufacturing, Quality and Process Development
Essential for the role
Upstream/Downstream Technology Transfer (TT) and/or cell culture/purification process development experience.
Experience in Biologics working in cell culture (cell lines such as mammalian) or purification of large molecules in therapeutic antibodies and/or vaccines.
Fundamental understanding of Upstream/Downstream unit operations such as cell culture scale up, harvest, affinity and ion exchange chromatography, low pH viral inactivation, virus filtration, and UF/DF.
Understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to Technology Transfers.
Knowledge of GMP manufacturing principles and documentation.
Ability to apply critical thinking to solve problems, work independently and support/lead complex investigations.
Strong interpersonal and communication skills.
Education and Experience Requirements
BS/BA/MS/PhD in Engineering, Biological/Physical Sciences, or equivalent focus of study.
BS 7+ years, MS 3+, PhD 2+ years in a cGMP biopharmaceutical production or process development setting with a focus in biologics
The annual base pay for this position ranges from $ 112,304 - $168,456 depending on level. 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.
Closing Date 01-Dec-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.
