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Cell and Gene Therapy Analytical Senior Scientist

Boston, MA

Posted: 02/21/2024 Industry: Scientific and Life Sciences Job Number: 16459

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

Title:  Cell and Gene Therapy Analytical Senior Scientist
Hiring Organization: Connexion Systems & Engineering
  • Duration: Contract
  • Pay rate: $38-57/hr
  • Job Location: Boston, MA (Hybrid)
  • Job# 16459

This Sr.Scientist/Scientist position will be part of Analytical Science and Technology (ASAT) team within Commercial Manufacturing & Supply Chain (CMSC) department. S/He will provide expertise in assay development and validation and E2E analytical supports to the commercial manufacturing and critical component release for the Cell and Gene therapy (CGT) portfolio.

Key Responsibilities:
  • Work independently or in collaboration with internal and/or external partners in analytical lifecycle activities including method development, validation, and method transfer
  • Author and/or review technical documents, including method SOP, study protocol and technical report
  • Be a key Subject Matter Expertise (SME) and represent ASAT to participate in troubleshooting and OOS investigation occurred during release and/or stability testing
  • Provide SME assessment for deviation, CAPA and change control 
  • Perform data trending analysis
  • Participate in internal and external meeting

Knowledge and Skills:
  • Excellent technical writing skills are essential
  • Hands-on experience and In-depth knowledge of protein and gRNA analysis required
  • Experience in Gene and Cell therapy is desirable
  • Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept.
  • Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
  • Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
  • Partners effectively with internal and external functions
  • Experience of using JMP or similar statistical tools is a plus
  • Experience with NGS technology is a plus

Education and Experience:
  • B.S or above in Biology, Biochemistry, Analytical Chemistry and related fields. 
Minimum 8 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.
 




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