Scientist, Cell and Gene Therapy Analytical

3 weeks ago


Boston Massachusetts, United States Vertex Pharmaceuticals Full time
Job Description:
This Research 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 certain analytical area supports to the commercial manufacturing and product 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

Be a 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

Participate in internal and external meeting

Author and/or review technical documents, including method SOP, study protocol and technical report

 

Knowledge and Skills:

Hands-on experience and In-depth knowledge of potency or microbiology assays

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 plus

Good technical writing skills

 

Education and Experience:

B.S or above in Biology and related field.

Minimum 4 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.

Pay Range:
$46 - $50/HR

Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

 

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If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.

 

No C2C or Third-Party Vendors

 



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