- Support Navy Yard manufacturing by carrying out and supervising QC in-process and release testing of t-cell products, this includes testing, reviewing/approving and reporting of data.
- Method / Technology Transfer of new methods into the Adaptimmune QC Lab, following qualification / validation of methods
- Managing direct reports
- Maintenance of Quality Control Protocols, SOP's and Test Methods
- Deviations, change controls, CAPAs
- Method / Technology Transfer of existing methods into the Adaptimmune QC Lab
- Five+ years working in a GMP quality control laboratory
- Advanced knowledge of GMP regulations including USP and EP testing requirements
- Ability to identify and implement continuous improvement projects for lab process efficiencies
- Advanced knowledge on process of technology transfers and method qualification requirements
- Advanced experience conducting time critical testing of in-process and finished product to meet clinical trial needs.
- Ability to prepare data trending reports, and to author, review and maintain test methods, qualification protocols, SOPs and reports
- Conduct laboratory investigations, initiate change controls, prepare deviations and CAPAs as needed
- Subject Matter Expert in a method or process within quality control
- Identifying risks within processes prior to implementation, through risk assessment
- Strong ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities
- Five or more years working in a GMP quality control laboratory.
- Ability to work on assigned projects independently.
- SME of Quality System applications such as; StarLIMS and MODA-EM
- Ability to independently coordinate testing activities
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Quality Control Operations - Philadelphia, United States - Adaptimmune
Description
Job Description
Job DescriptionAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
Primary Responsibility
The QC Operations Supervisor will be responsible for conducting /coordinating in-process, finished product and stability testing associated with Adaptimmune clinical trial material. The QCOPs Supervisor will handle scheduling of in-process and release testing within the group. In addition, the Supervisor is the Subject Matter Expert (SME) on release methods and processes associated with data capture and analysis. This role will manage the day to day operations as well as the respective personnel for test methods. When the need arises, this role may require participation in method transfers and protocol execution associated with Adaptimmune clinical trial material.
Key Responsibilities
Qualifications & Experience
Required
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
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