- Title: Assistant/Associate Scientist
- Code: RCI-41632-1
- Location: Devens, MA 01434
- Posted Date: 09/21/2021
- Duration: 12 Months
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
The successful candidate will be a key contributor to a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles; and delivering results within project timelines and will build and maintain effective collaborations with Manufacturing, Manufacturing Support, Process Development, Quality Assurance, Analytical and Global Regulatory Sciences groups.
- Strong communication, presenting, and technical writing skills are required.
- The incumbent will lead the design and execution of experiments for design & control of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations.
- Appropriate GLP/GMP procedures must be followed.
- This position also involves troubleshooting and problem solving of process related problems observed at manufacturing scale and the evaluation of new process technologies through the effective design of scale-down studies and the evaluation of data from manufacturing lots.
- Provides technical expertise for investigation and resolution of upstream process deviations, root cause investigation, CAPAs, process improvements, scale-down model development, new technology evaluation and preparation of regulatory filings.
- Demonstrates a strong knowledge of cGMP compliance, CLIENT corporate, site and regulatory agency requirements and procedures
- Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for CLIENT Devens Single Use Facility.
- Authors technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing upstream process
- Participates in the preparation of regulatory filing documents and inspection readiness
- Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Devens site
- Conducts experimentation and analysis to implement new process analytical technology for continual improvement of manufacturing processes
- Supports general laboratory functions and upkeep including cell culture seed trains, bioreactor setup/sampling, data logging, analytics support, lab hygiene and safety updates.
- B.S,or M.S. in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent.
- Experience in contributing to the design, modification and optimization of cell culture unit operations
- Proactively identifies problems and troubleshoots solutions
- Organizes and presents data for internal/external scientific meetings
- Works independently, in teams and collaborates with other groups in a matrix environment
- Leverages emerging trends in biotechnology to solve complex problems
- Capable and willing to train others on procedures, operations, new technology, methods or processes
Additional plus (optional)
- Proficiency in statistical methods
- Experience managing large datasets
- Interest in data management infrastructure
- 5S Experience