CRISPR Therapeutics Director, Framingham Site Quality Control in Framingham, Massachusetts
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.
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.
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.
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
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
Working with Contract GMP testing laboratories and vendors
Authoring IND, BLA or equivalent regulatory filings
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.
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