Cell Therapy Process Scientist III

Portsmouth, NH

Posted: 04/11/2019 Job Number: JN -042019-10625
Cell Therapy Process Scientist III

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: Cell Therapy Process Scientist III
Location: Portsmouth, NH
Industry: Biopharmaceutical
Hours: 1st Shift Monday-Friday, 8am-5pm
Salary: $85,000-$125,000k (depending on experience), plus relocation assistance for right candidate
Employment Type: Direct hire

Environment: This client is one the world s leading supplier to the pharmaceutical, biotech, biopharmaceutical and specialty ingredients markets. This location focuses on mammalian cell culture and large-scale production of biopharmaceuticals. We create products that support a healthier lifestyle and enhance ones quality of life. Isn t this a company you want to work for?


Summary
Our Cell Therapy Process Scientist/Engineers are responsible for being the primary technical support person for manufacturing processes. The supervisor provides direction and oversight, as this level of Process Scientist is expected to have a good grasp of the requirements of the role. The individual is a subject matter expert in manufacturing processes for allogeneic and/or autologous cell therapies in process development/process scale-up and/or manufacturing or tech-transfer; it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required.

Responsibilities
  • Performs all functions associated with process transfer and process support, e.g. develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, author / review planned deviations and change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes).
  • May provide guidance on process transfer and support activities to junior members of the team.
  • Assess all major deviations including those that impact product quality. Identifies potential root causes using a systematic approach. Experience using variety of problem solving tools e.g. Fishbone, Kepner-Tregoe etc. Able to identify potential solutions. Performs or is able to understand all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis.

Qualifications
  • Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering
  • Extensive biotech industry experience supporting allogeneic and /or autologous cell therapy process development / process scale up / tech-transfer/manufacturing.
  • Experience with cell therapy manufacturing support, current Good Manufacturing Practices, US / EU regulations.
  • Intermediate knowledge of cell culture for allogeneic and /or autologous cell therapy processes, cell biology, scale up and intermediate knowledge of statistical data analysis. Familiarity with cell therapy manufacturing, current Good Manufacturing Practices and US/EU regulations.
  • Experience within a CDMO or CMO is highly preferred
ADA/EOE
Search words: biomedical, biological, scale up, technical transfer, cell therapy, process development, cell biology, manufacturing, Fishbone, allogeneic, autogous,
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