Senior Manager, Quality Control Bioanalytical

CRISPR Therapeutics

Framingham, MA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 02/15/2021
  • Website: crisprtx.com
  • Company Address: 610 Main Street, Cambridge, MA, 02139

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene-editing company focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.

Job Description

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

Our newly formed Quality Control group is seeking for an experienced Senior Manager to lead the analytical laboratories set up and overseen the bioanalytical operations. A key member of the Quality Control team, this individual will lead analytical method tech transfers and validations to our state-of-the-art laboratories. This highly visible position is based in Framingham, MA, and reports to the QC Director.

Responsibilities

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

  • Overseeing analytical equipment installation and qualification.
  • Working closely with the Quality Analytical Science and Quality Assurance to ensure analytical methods are appropriately written, implemented, and validated.
  • Authoring, reviewing, and approving policies, SOPs, Test Methods, and related documents needed to operate a QC laboratory in compliance with GMP 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:

  • Managing the QC Bioassay laboratory operations including testing of cell therapies and AAV product.
  • Overseeing approval of specifications and procedures that impact product quality attributes.
  • Recruiting, developing, and mentoring staff and provide support to ensure successful accomplishment of business goals.
  • Supporting the establishment of reference standards and control programs.
  • Assisting during laboratory inspections and provide documentations to regulatory agencies.
  • Representing QC on cross functional teams supporting raw material initiatives.
  • Creating and managing material specifications associated with bioassays.
  • Managing raw material samples testing schedules with internal and external testing labs.
  • Acting as the subject matter expert for investigation and resolution of deviations as well as out-of-specification (OOS) and out-of-trend (OOT) testing results.
  • Supporting regulatory submissions (e.g. INDs, BLAs).
  • Developing cooperative and strong working relationships with Manufacturing, Quality Analytical Science, Quality Assurance, and other stakeholders to achieve company objectives.
  • Maintain the QC Bioanalytical laboratories in a safe and compliant manner.
  • Participating in business sub-teams as a subject matter expert to provide input on timeliness and to address bioassay related issues.
  • Ensuring generation of Certificate of Analysis.
  • Performing other duties based on business needs.

Qualifications

  • Bachelor’s degree in biochemistry or related scientific field is required. Advanced degree preferred.
  • Minimum 7 years of relevant analytical testing or Quality Control or equivalent combination of education and experience, preferably in a regulated environment.
  • Direct experience with flow cytometry, qPCR, in-vitro bioassays, cell culture, and compendial methods.
  • Prior experience with analytical method validation and transfer, and regulatory filings (e.g. IND, BLA).
  • Strong understanding of applicable USP, ICH, and Ph Eur regulations related to QC testing.
  • Experience with generating material specifications for bioassays.
  • Effectively collaborate with 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

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.