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Roivant Sciences // biomedical research
 
Roivant Sciences, 320 West 37th Street, New York City 10018, United States    Posted: Tuesday, January 28, 2020
 
   
 
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JOB DETAILS
 

We seek a highly motivated Scientist with demonstrated expertise in Stem Cell therapy development to driving tech transfer, process characterization & validation activities to support rapid commercialization of cell therapy products. The qualified candidate will be responsible for managing process transfer of cell therapy processes to CMOs in US & EU to ensure timely manufacturing readiness.

The successful candidate will also be required to review regulatory documents for submissions & provide technical input to regulatory discussions. Significant technical expertise in cell therapy process development & strong project management skills are required for this position. This role will also involve extensive interaction with collaboration partners, technical transfer teams & collaboration within cross-functional teams.

The preferred location for the position is New York City.

Responsibilities:

  • Provide necessary technical & Laboratory support to process Development team; Act as Person-In-Plant (PIP) for development & Manufacturing activities
  • Lead development activities with experience (strongly preferred) in the following areas:
    • Immune cell or hematopoietic cell product development
    • Platforms for characterizing immune cells
    • Platforms & technologies for immune cell selection & isolation
    • Managing cell therapy process development at CRO/CDMOs.
  • Serve as a process SME from CMC in cross-functional teams & support execution of process operational strategies.
  • Design (DOE), plan, & execute process development experiments & troubleshoot existing protocols to increase process performance as measured by efficiency, process robustness & final product yield.
  • Oversight on development of assays at CDMO towards characterizing edited populations of HSCs
  • Interact with other CMC teams, Quality Operation, Clinical Operation, Regulatory & other personnel as dictated by project needs. Contribute in a team-oriented environment to achieve common project goals
  • Maintain knowledge of scientific literature & apply key concepts to project activities/plans.
  • Manage process transfer efforts & drive the execution plan of process transfer activities & manage timelines & deliverables
  • Review technical documents, including study protocols, study reports, batch records, SOPs, etc. to ensure the process readiness at CMOs.
  • Assist CMOs in the development of process transfer, qualification & validation study plans.
  • Assist CMOs in preparing various process related protocols & investigations.
  • Participate in key tech transfer & process validation activities at CMOs.
  • Review regulatory documents for BLA/MAA filings.
  • Provide necessary technical input to support regulatory discussions in US & EU

Prerequisite:

  • Ph.D. in Biochemical Engineering or related discipline with 3+ yrs. process development experience, or MS with 5+ yrs., or BS with 8+ yrs. Process development experience for Cell therapies is highly preferred.
  • Strong grasp & application of engineering fundamentals pertaining to Cell Therapy process development, specifically on stem cell therapy
  • Experience with process development, tech transfer activities
  • 30% Travel

Skills/Knowledge Required:

  • In-depth knowledge & technical expertise in process development for cell therapies or, biologics.
  • Strong knowledge in cGMP of cellular products or biologics
  • Solid understanding of the fundamentals of process development, tech transfer & validation.
  • Excellent organization, verbal & written communication & presentation skills.
  • Ability to work in cross-functional teams effectively & interacting with external collaborators to build strong relationship.
  • Ability to work independently.
  • Ability to develop & drive project plan & timeline & deliverables to meet overall project goals.
  • Experience in project management.
 
 
 
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