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Manager Quality Control, Gene Therapy

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treatand even cureseveral of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertexs continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

VCGT has an opening for a QC Manager.

Key Responsibilities:

* Manage a group of QC analysts and oversee the expansion of the QC group to three or more analysts in 2020 * Train on and personally execute QC tests in a laboratory setting * Work collaboratively with the Analytical Development group to ensure successful transfer of developed assays to QC and to resolve any technical issues that arise during execution of that transfer * Ensure that all assays transferred to the QC group are qualified and, ultimately, validated * Work with Quality Assurance to ensure the timely and successful resolution of QC investigations associated with deviations, test failures and test results that fail to meet acceptance criteria * Work with contract testing labs to ensure proper execution of outsourced QC tests * Order, review and maintain stocks of standards and other QC reagents as required for testing schedule * Coordinate and assign testing responsibilities of QC staff * Review and approve execution of QC tests as per batch record. Ensure controls for each test met standards * Oversee and schedule routine analytical testing for PD as assigned by QC leadership * Ensure all QC laboratory equipment is in calibration and serviced as required to maintain compliance. * Ensure all analysts are current on procedures and procedural updates as required.

Minimum Requirements:

* Bachelors degree in Biochemistry, Cell & Molecular Biology, Genetics or related discipline * At least 3-5 years experience managing Quality Control groups at a company specializing in the development of gene therapies * At least 3-5 years experience working in a GMP environment * At least 3 years experience supervising the execution and qualification/validation of analytical tests for the quantification and characterization of AAV vectors (in-process, lot release and stability testing) * Technical proficiency executing the following assays: ddPCR, qPCR, RT-qPCR, SDS-PAGE, ELISA, Western blots and cell-based potency assays * Knowledge of 21CFR 210, 211, 600, 610 and 1271 as well as the ICH Quality Guidelines Q2(R1), Q5C, Q6B, etc. * Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team

Preferred Requirements:

* At least two years experience supervising stability programs for drug substance, drug product and cell banks * Experience working with external contract testing labs * Experience with sample management and LIMS systems * Experience with statistical software (JMP, SAS, Prism, etc) for data trending and setting expiry

#LI-KW1

Keywords: Vertex Pharmaceuticals Inc (US), Boston , Manager Quality Control, Gene Therapy, Executive , Boston, Massachusetts

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