Research Scientist Cell and Gene Therapy Analytical Contract
Research Scientist Cell and Gene Therapy Analytical Contract
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Job Description
Job Description
Job Summary:
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 microbiology related analytical 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 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
Participate in internal and external meeting
Author and/or review technical documents including method SOP study protocol and technical report
Author and/or review regulatory filing/response
Knowledge and Skills:
Handson experience and Indepth knowledge of microbiology or potency 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 latestage 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 8 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.
Pay Range
$50$60/HR
Requisition Disclaimer
This job posting is for a temporary role with a thirdparty 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 thirdparty 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 jobrelated factors permitted by law. In addition this role will be eligible for overtime pay in accordance with federal and state requirements
By applying for this position you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials which may include your CV/Resume email address or phone number with Vertex. For more information on how Vertex handles your personal data related to your job application please see Vertexs Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings profiles articles news and other employmentrelated information as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
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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 ThirdParty Vendors
Employment Type
Unclear
