What are the responsibilities and job description for the Quality Control Specialist - Microbiology position at Adaptimmune?
Adaptimmune 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
This is an onsite role in our Philadelphia Navy Yard site.
The Quality Control Specialist will be responsible for conducting /coordinating in-process environmental monitoring of cGMP suites, finished product safety tests (endotoxin, sterility), and stability testing associated with Adaptimmune drug products. This individual is generally considered the Subject Matter Expert (SME) on environmental monitoring and drug product safety tests. This role has the ability to operate independently and troubleshoot issues associated within the quality control laboratory.
Key Responsibilities
Qualifications & Experience
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
This is an onsite role in our Philadelphia Navy Yard site.
The Quality Control Specialist will be responsible for conducting /coordinating in-process environmental monitoring of cGMP suites, finished product safety tests (endotoxin, sterility), and stability testing associated with Adaptimmune drug products. This individual is generally considered the Subject Matter Expert (SME) on environmental monitoring and drug product safety tests. This role has the ability to operate independently and troubleshoot issues associated within the quality control laboratory.
Key Responsibilities
- In-process environmental monitoring, finished product testing and stability testing.
- 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
- Ensuring daily schedule is maintained for QC operations
Qualifications & Experience
- Bachelors of Science degree in a Scientific discipline
- 3-5 years working in a cGMP quality control microbial laboratory
- Advanced knowledge of cGMP regulations including USP and EP testing 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 and of prepare deviations and CAPAs as needed
- Ability to identify and implement continuous improvement projects for lab process efficiencies
- Ability and desire to effectively work independently or in an interdisciplinary team environment
- Effectively interact at multiple levels within the company to support internal manufacturing capabilities
- Previous Gown Qualification for aseptic processing experience
- Ability to work on assigned projects independently with limited supervision.
- Advanced knowledge with rapid microbiology methods, Endotoxin testing, and EM monitoring
- Experience using MODA and LIMS software
