Therapeutics is focused on developing transformative gene-based medicines for serious human diseases using the breakthrough CRISPR-Cas9 genome-editing technology. Our multi-disciplinary team of world-class researchers, drug developers, and clinicians work to translate the CRISPR-Cas9 technology into human therapeutics. Our lead programs in Hemoglobinopathies and Immuno-oncology are currently at the Clinical stage.
CRISPR is headquartered in Basel, Switzerland with operations in the UK, Massachusetts, and California.
For more information, please visit www.crisprtx.com
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 the Corporate Head of Quality; is a high visibility, high impact position requiring concurrent strategic and tactical contributions.
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
- Implementing an electronic Data Management System
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 of Reference Standards and Sample management
- 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
- 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.
- 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, and biophysical assays
- Experience in management of Reference Standards/Sample/Data management and Stability studies
- Experience in drafting study protocols, reports, and compliance documents
- 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
- 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