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Contract Vector Manufacturing, Downstream Lead

This role will be recruited only if we need to backfill the 'Vector Manufacturing, Downstream Lead' position to allow handover before we are able to onboard the permanent employee.

 

Primary Responsibility

To lead and coordinate manufacturing activities, ensuring operations are carried out efficiently and accurately.  This includes participating in cross functional teams to resolve technical issues and deviations and demonstrating mastery knowledge of viral vector manufacturing (upstream and/or downstream processes), acting as Subject Matter Expert (SME) for manufacturing operations.

 

Key Responsibilities

  1. Trouble shooting process and equipment related issues, performing investigations in a manner that is recognized by colleagues as a valuable source of expertise.
  2. Documenting production operations in corresponding batch records and log books per established procedures ensuring accuracy and timely completion, identifying real time manufacturing issues (deviations and atypical results) and communicating them to the Manufacturing Manager and the Quality team in a timely manner.
  3. Drafting or modifying manufacturing documents with the Manager and Quality Team oversight. These documents include but are not limited to training records, copies of batch records and the Certificates of Analysis of the viral vector, SOPs and Batch Record versions, equipment and other log books, validation documentation.
  4. Inputting and uploading manufacturing data (as required) in real time to identified systems or databases.
  5. Working with the Quality team to author out of specification (OOS) reports, deviation investigations and corrective and preventative actions, as well as authoring SOPs, batch records, validation plans and technical reports as assigned.
  6. Actively coaching/mentoring other Specialists, providing training as needed.
  7. Performing other manufacturing duties as assigned, include but not limited to: schedule equipment cleaning, coordinates maintenance, represent Adaptimmune with Catapult C&GT personnel.  Performs vector manufacturing related activities while wearing clean room attire in an aseptic cGMP manner.  Serves as the back-up for Vector Manufacturing Manager
  8. Performing validation and process development runs using vector manufacturing equipment.
  9. Helping with warehouse management, critical reagents and material inventory reports.

 

Qualifications & Experience

Required

  • Bachelor degree in a cell biology, chemical engineering, bioengineering or medical technology related field, or equivalent experience is required with significant experience of manufacturing or pharmaceutical/Biotech aseptic processing experience. 
  • Understanding of GMP operations
  • Experience with biologic manufacturing of cell based products (e.g. biopharma, biotech, vaccines, upstream and/or downstream processes)
  • Ability to be flexible with working hours e.g. able to work evenings/weekends and/or shifts if necessary for production schedules
  • Knowledge of Aseptic Manufacturing/Processing, including experience working in aseptic cleanroom with full aseptic gowning

 

Skills & Competencies

Required

  • Excellent verbal and written communication skills
  • Ability to work independently and to a high standard
  • Excellent interpersonal skills—works well with others, both within function and with other functions
  • Excellent team player
  • Demonstrable leadership attributes and is a role model to others
  • Ability to work effectively with change and ambiguity
  • Positive, “can do” attitude
  • Effective problem solving skills—identifies solutions to issues and brings to attention of manager
  • Willingness to take on additional responsibilities, eg projects, process improvement initiatives, etc…
  • Looks for opportunities to contribute in other ways to the success of Adaptimmune
  • Computer literacy is required including Microsoft Outlook, Word, Excel and Power Point.

     

Other Requirements

  1. Ability to stand for multiple hours and lift 20 pounds
  2. In order to enter the clean room environment the following things need to be taken into consideration:
  • No make-up/eyelashes/nails/ henna tattoos etc., fresh tattoos need to be discussed with manager if danger of contamination of cGMP product.
  • Entry into the Production Area will consist of full change of clothes into Production overalls. A mob cap is needed to cover hair, and a beard snood for facial hair.
  • Entry into the Cleanroom will consist of a further change into plastic all-in-one overalls. Disposable gloves must be worn at all times in the cleanroom.

 

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