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CRISPR Therapeutics Director, Framingham Site Quality Control in Framingham, Massachusetts

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 partnerships 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 in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary

The Director of Quality Control will lead a Site QC Department supporting Facility commissioning, GMP manufacture, and drug product release testing in a new CRISPR facility under construction in Framingham, MA.  This position reports to Head of cGMP Analytical and Global Quality Control is a high visibility, high impact position requiring concurrent strategic and tactical contributions.

Responsibilities

During the facility completion stage, as part of the Site Management Team, this position is responsible for:

  • Build-out of a QC function including leading Instrument IQ/OQs and Analytical Methods transfer, qualification, and validation

  • Hiring and on-boarding QC personnel including managers and analysts per recruitment plan

  • Leading development of Policies, SOPs, and Test Methods required for operation of a QC laboratory

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

  • Phase appropriate Qualification and Validation of Analytical Methods

  • Bio-Analytical testing of raw materials, process intermediates, and drug product

  • Management and oversight of the Quality Control laboratory for in-process, release, stability, and characterization testing, including microbiological testing, in support of a manufacturing facility.

  • Data management, trending, Data Integrity

  • Oversight of laboratory investigations, OOS, and Change Control

  • Issuance of QC batch Certificate of Analysis

  • Developing curricula for training analysts

  • Facility Environmental Monitoring

  • Performing Quality Metrics and annual report reviews

  • Define the need of the laboratory in terms of equipment and people. Responsible for preparing QC budget of expenses and Capex

  • Maintaining the QC function in state of compliance and Inspection readiness

Key internal partners include Manufacturing, Analytical Development, Facilities, Supply Chain, IT, Regulatory Affairs, and Quality Assurance.

Minimum Qualifications

Technical Qualifications:

  • Ph.D. in Biological/Analytical Sciences with a minimum of ten years, or B.S./M.S. with fifteen years, of experience in GMP Quality Control

  • In-depth knowledge of FDA/EMA/ICH regulations and guidelines; pertaining particularly to Gene Therapy/Gene Editing drug development platforms

  • Expertise in Gene Editing Analytical Methods ranging from molecular biology, cell biology, flow cytometry, biochemical, biophysical, microbiological and other safety-related assays.

  • Experience in drafting study protocols, reports, and compliance documents

Leadership Qualifications:

  • Solid organizational, staff mentorship, and time management skills with attention to detail

  • Proven ability to negotiate, influence, and work in a matrix environment

  • Handling multiple assignments in a fast-paced environment with changing priorities

  • Independent development and execution of plans with minimal supervision

  • Strong analytical, problem solving, and critical thinking skills

  • Excellent written and oral communication skills

Preferred Qualifications

  • Gene Therapy / Gene Editing drug development/commercialization

  • Building a QC function

  • Health Agency pre-approval inspections

  • Use of statistical software (e.g., JMP, SoftMax Pro, Gen5) to establish specifications

  • Environmental Monitoring

  • Working with Contract GMP testing laboratories and vendors

  • Authoring IND, BLA or equivalent regulatory filings

Competencies

  • Collaborative – Openness, One Team

  • Undaunted – Fearless, Can-do attitude

  • Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.

  • Entrepreneurial Spirit – Proactive. Ownership mindset.

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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