Job Summary: This Scientist position will be part of Analytical Science and Technology (ASAT) team within Commercial Manufacturing & Supply Chain (CMSC) department. S/He/They 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 in-vitro cell-based functional/potency assays is required. · Experience in flowcytometry is desirable. · Experience in Gene and Cell therapy is desirable. · Experience in managing contract testing sites (CTO/CDMO) is recommended. · 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.
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. |
$42-$45/HR
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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