Manager/Senior Manager, QC
At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.
We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other diseases
Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.
This Manager/Sr. Manager position is responsible for developing and maintaining GMP, ISO compliant labs, to assure that all products meet product specifications. This position is charged with ensuring all the Quality Assurance Systems are fully implemented and Quality Control Procedure and Practice are standardized and followed. This is a highly visible and dynamic position requiring strong leadership and facilitation skills to balance multiple priorities in a highly matrix/team-based organization.
We are seeking a Manager/Sr. Manager QC, to join an exciting, fast-growing and well-financed company to develop novel gene editing therapies for serious diseases at CRISPR Therapeutics. The successful candidate will be responsible for managing a QC lab to release Cell and Gene Therapy products. The position will interface with the within Tech Ops, R&D to provide a strategic view of late Stage development to meet the needs of our growing clinical products portfolio and launch of commercial product. The ideal candidate has significant experience with analytical development, validation, tech transfer, comparability protocol and CMC.
- Manage a future QC department to test Crispr IO. HEME and AAV lot release assays
- Maintain a strategic view of the relationship with internal and external partners in the Manufacturing organization, organize meetings as needed to form a strong and effective partnership.
- Work with Late stage analytical group, MSAT group to get timelines on assay transfer timelines
- Validate QC assays for lot release of Crispr Drug substance and drug products
- Perform control trending of analytical assays
- Manage constant supplies of inventories and lab supplies
- Manage the samples management and schedule the testing of the test samples
- Manage the lab investigations, OOS and deviations. Apply problem solving techniques (5Why, 5M, FMEA, GR&R, etc.) and apply advanced statistical methods for data analysis.
- Writes necessary quality plans, SOPs, work instructions, validation protocols and reports
- Provide leadership and management support for activities to drive a fast paced, highly efficient learning culture.
- Be a champion of a highly collaborate, transparent, data driven, \'make it happen\', culture.
- Ensures that product quality is maintained through application of analytical test
- Perform duties as need basis.
- BS/MS with 5-8 years or Ph.D. with 3-5 years relevant industry experience in managing QC Labs with a degree in Biology, Chemistry, Chemical/Biochemical Engineering or related scientific discipline.
- Experience in writing SOPs, Work Instructions, Quality polices, Qualification and validation experience
- Experience in validation of analytical assays for ICH guidelines
- Experience in tech transfer and comparability protocols
- Experience in managing Environmental Monitoring is a definite plus
- Experience in working with CDMOs/CMOs and third parties for process development and cGMP manufacturing activities.
- Ability to effectively communicate and collaborate with internal and external stakeholders is essential.
- Proven ability to mentor and coach more junior team members and develop a strong team.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Self-driven, independently motivated, data driven and excellent problem-solving ability.
- Available to travel both domestically and internationally.
- Support CMC Analytical activities for Crispr clinical programs
- Perform Data Review, data trending, control charts trending, QMR. Implement departmental Quality Metrics System.
- Organize data in a highly organized manner, providing statistical analysis and troubleshooting where appropriate
- Cross-functional and highly visible position within Technical Operations group. Position requires active collaboration with research, process development and quality teams and CDMOs
- Provide expertise on multiple techniques to support trouble shooting and enhancing of existing assays.
- Support assay qualification and validation activities and interact with CMOs and other vendors, as required.
- Support analytical sections of regulatory filings for US, Europe and ROW.
- Lead department deviation investigation and CAPA management
- Oversees instrument and method validation
- Write SOPs, Qualification Protocols and qualification reports
- Ability to manage the technical and strategic needs of multiple projects in a fast-paced environment is required
- Oversee stability program to support clinical development and regulatory filing
- Transfer technology to external CROs and CMOs
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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