Scientist I - Manufacturing Sciences
About The Position
This role focuses on Technology Transfer and Process Development for injectable and sterile pharmaceutical products, supporting projects from early process development through commercial scale-up and validation. The position works closely with Formulation, Filling, and Freeze Drying operations to develop, transfer, optimize, and troubleshoot manufacturing processes. The individual will support client technology transfers, process development studies, scale-up activities, process validation, manufacturing support, investigations, and change controls. The role also involves analyzing process data, developing technical solutions, preparing GMP documentation, and communicating technical findings with internal teams and clients.
Requirements
- Bachelor of Science in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Engineering, or a related physical science, plus 1+ year of related experience; or a related Master's degree.
- Strong knowledge of scientific methodology and pharmaceutical process development.
- Detailed knowledge of Good Manufacturing Practices (GMP).
- Technical expertise in upstream/downstream biopharmaceutical manufacturing and/or process development.
- Prior experience with technology transfer or process validation.
- Strong written, interpersonal, and presentation skills.
- Ability to lead or participate in technical discussions with internal teams and external clients.
- Strong problem-solving and decision-making abilities.
- Ability to manage multiple projects simultaneously.
- Ability to learn pharmaceutical processes, equipment, instrumentation, and procedures.
- Ability to stay current with scientific literature and industry trends related to process technologies.
- Ability to develop and implement technical solutions.
- Ability to collect, analyze, interpret, and summarize process data.
- Ability to work effectively in GMP manufacturing and laboratory environments.
- Ability to stand and walk as required and lift/carry objects up to 25 lbs. for brief periods.
- Ability to use required PPE during manufacturing activities, client visits, or facility tours.
Nice To Haves
- Experience in a CDMO or pharmaceutical product development environment preferred.
Responsibilities
- Complete technology transfer activities, process development studies, commercial scale-up, and process validation support.
- Perform manufacturing process development for injectable products transitioning to commercial manufacturing lines.
- Use experimental design to establish formulation processes, product pathways, and component selection for successful scale-up.
- Provide technical support to daily operations in Formulation, Filling, and Freeze Drying areas.
- Develop and implement technical/scientific strategies and solutions for processes, products, and projects.
- Assist in creating processes, single-use systems, and equipment designs for clinical, scale-up, and registration batches.
- Support technology transfer of projects from clients.
- Support client calls and provide project updates and scientific justification.
- Prepare documentation including work orders, protocols, reports, summaries, memos, and forms with minimal supervision.
- Represent the organization during internal technical discussions.
- Participate in problem-solving activities related to formulations, equipment, and manufacturing processes.
- Support projects with moderate supervision while maintaining timelines and project goals.
- Implement change control actions and review technical aspects of projects.
- Support manufacturing operations, change controls, and investigations as a Subject Matter Expert (SME).
- Collect data for statistical analysis and support interpretation and summarization of results.
- Contribute to project results and technical solutions.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
