Assistant/Associate Scientist

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Job description

Job Title: Assistant/Associate Scientist

Duration: 12 Months Assignments

Location: Devens, MA 01434

Candidate will be required to report onsite. Remote work is possible - will need to be onsite at times

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, corporate, site and regulatory agency requirements and procedures

- Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for 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.

Qualifications:

- 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