Senior Scientist, Chemical Engineer Position Description
- Department: Research & Development
- This department invents synthetic processes to prepare active pharmaceutical ingredients (APIs) to enable the development of the company's pipeline, and ultimately to provide commercial manufacturing processes.
- Our Client is seeking a highly motivated individual with a proven track record of accomplishment to join the API Pilot Plant Technical Operations (Tech Ops) group. This position will serve as a liaison between the Process Research and Development scientific functions and the API Pilot Plant organization.
- The successful candidate will assist in the optimization and scale-up of synthetic processes and facilitate the implementation of the processes and new technologies in to the API Pilot Plant.
- The Scientist will also provide technical oversight during production campaigns and will support technical transfer to the ultimate commercial manufacturing site.
Position Requirements Basic
- Management of processes entering the API Pilot Plant, including scheduling, equipment selection, materials tracking, authoring direction sets, obtaining safety analyses, and executing pre-runs.
- Technical oversight of processes running in the API Pilot Plant, and responsibility for process-trouble shooting in collaboration with the project teams.
- Serves as primary point of contact between API Pilot Plant, project teams, Quality Assurance, and Environmental Health and Safety.
- Responsible for review and documentation of data for cGMP execution of chemical processes. Authors campaign summary reports.
- Identify, evaluate and implement new technologies for the pilot plant and/or identify opportunities to modify or leverage existing assets to enhance operational efficiency. Examples include automation, flow chemistry, novel separation, Process Analytical Technology (PAT) feedback control and drying technologies.
- Support the implementation of PAT. Assist with equipment specification, setup, data collection and analysis.
- Interface with project teams to ensure that processes are safe and operable.
- Partner with API development teams to optimize processes for scale-up. Identify appropriate equipment and configurations.
- Assist with technology transfer of late stage processes to commercial sites, including process fit, identification of equipment needs, and facility modifications.
- BS, MS, PhD in Chemical Engineering with 14+ (BS), 12+ (MS), or 6+ (PhD) years of experience
- 3 Years (minimum) in drug substance development
- Understanding of cGMP, process safety requirements, and OSHA chemical hygiene plans.
- Working Knowledge of analytical techniques such as HPLC, GC, NMR, and microscopy
- Experience with Process Analytical Technology
- Experience with laboratory experiments, process scale-up from lab to pilot plant and/or transferring a process from pilot plant to a commercial facility.
- Experience working in an API Plant environment, familiarity with operation of chemical process equipment and systems.
- Strong technical background in chemical processing unit operations including reactions, crystallization, distillation, extraction, membrane separation, chromatography, centrifugation, filtration, drying and milling.
- Full Package with possible relocation
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.