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Senior Manager, Quality Control Microbiology

Company: CRISPR Therapeutics AG
Location: Framingham
Posted on: June 6, 2021

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 dynamic microbiologist leader with experience managing QC microbiology and environmental monitoring laboratories. This highly visible position will establish good practices and continuous improvement programs for microbiology-related activities, including managing and developing the QC Microbiology team. The QC Microbiology Sr. Manager will be based in Framingham, MA, and reports to the QC Director.

Responsibilities

During the facility completion stage, this position is responsible for:

  • Overseeing equipment installation and qualification in the environmental monitoring and QC microbiology laboratories.
  • Implementing the Environmental Monitoring program at the Framingham facility.
  • Authoring, reviewing, and approving policies, SOPs, Test Methods, and related documents needed to operate a QC laboratory in compliance with cGMP regulations.
  • Recruiting and on-boarding QC analysts.
  • Supporting the implementation of an electronic data management system.

Upon completion of facility commissioning and qualification, this position is responsible for:

  • Oversight of microbiological testing programs for all stages of clinical and commercial manufacturing operations including endotoxin, bioburden, sterility testing, microbial ID testing, raw materials, water, and environmental monitoring.
  • Developing, implementing, and maintaining of quality control systems.
  • Managing change controls, EM excursions, OOS/OOT events and driving deviations to closure in a timely manner.
  • Serving as the SME for QC Microbiology during regulatory audits and filings.
  • Maintaining the QC Microbiology laboratory in a compliant manner.
  • Representing QC-Microbiology on cross functional teams supporting raw material initiatives.
  • Creating and managing material specifications associated to microbial testing.
  • Managing raw material samples testing schedules with internal and external testing labs.
  • Developing cooperative and strong working relationships with Manufacturing, Quality Analytical Science, Quality Assurance, and other stakeholders to achieve company objectives.
  • Supporting regulatory submissions (e.g. INDs, BLAs).
  • Participating in business sub-teams as a subject matter expert to provide input on timeliness and to address environmental monitoring and microbiology related issues.
  • Coaching and development of QC Microbiology personnel.
  • Align departmental objectives with overall Company/Quality/QC goals and priorities.
  • Assure a safe work environment (in lab and office spaces) for QC Microbiology personnel.
  • Performing other duties based on business needs.

Qualifications

  • Bachelor's degree in microbiology, biology, or related discipline.
  • Minimum 7 years of relevant work experience, preferably in aseptic manufacturing of cell therapies or AAV products.
  • Experience managing environmental monitoring programs and safety release testing of drug products.
  • Strong understanding of applicable USP, ICH, and Ph Eur regulations related to QC testing.
  • Experience with generating material specifications for microbial testing.
  • Effectively collaborate with both internal and external stakeholders.
  • Ability to work independently and effectively, prioritize and deliver on tight timelines.
  • 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.
  • Experience with cell therapies, AAV and LIMS is preferable.

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: http://www.crisprtx.com/about-us/privacy-policy

Keywords: CRISPR Therapeutics AG, Framingham , Senior Manager, Quality Control Microbiology, Other , Framingham, Massachusetts

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