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Senior Manager/Associate Director, Quality Control

Company: CRISPR Therapeutics
Location: Framingham
Posted on: May 9, 2022

Job Description:

Company Overview CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. Job Summary The Quality Control team is looking for an experienced leader to manage the build out of an internal Quality Control Team and Function at the new Framingham Facility. This highly visible position will lead a team of individuals supporting internal testing operations including method transfer, qualification, and routine execution. Additionally, this position lead teams in support of raw material release, in process testing and method lifecycle management. Responsibilities Oversight and management of the QC Analyst Team, 4-8 team members, contractors, etc. Coordination of Method Lifecyle activities on behalf of QC: Method Insourcing, Feasibility and Transfer Authoring, review, approval of Test Method SOPs and related protocols. Lead and Own Lab start up activities for full suite of analytical equipment, in support of CGT Product and starting material testing. Lead and own Change Controls, Deviations, CAPAs and other quality system records on behalf of the QC team, drive investigations, resolution, and documentation. Communication and project management of Method Lifecycle projects, including coordination with CMC teams, and cross functional operations groups. Coordinate testing plans, schedules, and analyst resources to meet the needs of the manufacturing and drug product disposition schedules and timelines. Coordinate with Analytical Development to optimize, improve and remediate test methods and related operations. Lead and support the program development for the qualification of reference standards, critical reagents, and assays controls. Recruiting and on-boarding QC staff as applicable. Support start up, expansion and management of the QC LIMS system to support all QC operations. Support the transition of GMP responsibilities to QC from existing internal stakeholders. Coordinate with internal QC Sample Management and Operations teams to manage sample distribution, chain of custody and related investigations. Supporting regulatory submissions (e.g., INDs, BLAs), coordinate data requests, compilation, and management of externally generated data. Act as compliance lead for the QC Analytical Team- Monitor training, quality system, procedure, and process compliance for the team, including metrics reporting and remediation. Qualifications Bachelor---s degree in a related discipline, e.g.: Chemistry, Biology, Microbiology, etc. Advanced degrees in relevant areas preferred. Minimum 7 years of relevant work experience in managing GMP lap operations, preferably in the Cell Therapy or Gene Therapy space. Experience and technical knowledge associated with Flow Cytometry, PCR, Cell Culture and related equipment. Experience with Lab Start efforts, including equipment install, qualification and GMP release. Experience as a people manager, including recruiting and hiring operations. Experience with method lifecycle activities, including method insourcing projects, method feasibility, qualification, transfer, etc. Strong understanding of applicable USP, ICH, and Ph Eur regulations related to QC testing, CMO/CTL oversight. Background with clinical program integration, specifically with new clinical product filings and related QC Considerations. Ability to work independently and effectively, prioritize and deliver on tight timelines. Ability to manage changing priorities, plan and communicate impacts to leadership in an effective manner. Outstanding problem-solving abilities. Demonstrated ability to lead in a collaborative environment with a positive leadership style and hands-on approach that emphasize teamwork and consensus. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link:

Keywords: CRISPR Therapeutics, Framingham , Senior Manager/Associate Director, Quality Control, Executive , Framingham, Massachusetts

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