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    5 days ago

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    5 days ago

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    1 week ago

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    4 days ago

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    3 weeks ago

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  • Director, Quality Control

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    3 weeks ago

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    1 month ago

    Philadelphia, United States Planet Pharma Full time

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Quality Control Analytical Trainer

1 month ago

Philadelphia, United States Adaptimmune Full time
Job DescriptionJob Description

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

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 Quality Control Analytical Trainer will be responsible for training all personnel on assays and method transfers with Adaptimmune products. In addition, they are generally considered the Subject Matter Expert (SME) on a release methods or processes associated with data capture and analysis.  This role has the ability to operate independently and troubleshoot complex issues associated with the quality control laboratory.

Key Responsibilities
  • Training of in-process, finished product and stability testing of clinical trial material as well as training documentation
  • Method / Technology Transfer of existing methods into the Adaptimmune QC Lab
  • Maintenance of Quality Control Protocols, SOP’s and Test Methods
  • Deviations, change controls, CAPAs
Qualifications & Experience
Required
  • Five+ years working in a GMP quality control laboratory
  • Subject Matter Expert in a method or process within quality control
  • Advanced knowledge of GMP 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
Desirable
  • Five or more years working in a GMP quality control laboratory.
  • Ability to work on assigned projects independently with limited supervision.
  • Advanced knowledge with flow cytometry, ELISA, cell-based potency assays
  • Ability to independently coordinate testing activities

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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