Job Details

  • Title: Assistant/Associate Scientist
  • Code: RCI-41632-1
  • Location: Devens, MA 01434
  • Posted Date: 09/21/2021
  • Duration: 12 Months
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  Job Description

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


Job Description:              

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. 

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