The purpose of the role is to provide senior manufacturing expertise to Adaptimmune Manufacturing team to deliver GMP batches of viral vector. Working closely with the team of manufacturing specialists in Adaptimmune Manufacturing suite, the job holder is responsible for the oversight and execution of vector manufacturing in the clean room. Responsibilities include planning, supervising, documenting and troubleshooting in the designated area of expertise. The role also includes technical support to the team lead and site manager as well as technical communications to other supporting functions. The role requires expertise in authoring and reviewing GMP documentation as well as co-ordinating daily manufacturing tasks.
The role is based at the Cell and Gene Therapy Catapult Manufacturing Centre, Stevenage, UK.
- Performing vector manufacturing related activities to aseptic cGMP standards (clean room attire required and provided). Focused primarily on specific unit operations (e.g. upstream or downstream).
- 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.
- Responsibility for 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, SOPs and Batch Record versions, equipment and other log books, validation documentation.
- Entering and uploading of manufacturing data in real time to existing database.
- Working with the Quality team to author out of specification (OOS) reports, deviation investigations and corrective and preventative actions.
- Authoring SOPs, batch records, validation plans and technical reports as assigned.
- Performing validation and process development runs using vector manufacturing equipment
- Supporting facility GMP compliance activities.
- Supporting training and safety initiatives including any applicable GMP requirements for working in area.
- Helping with warehouse management, critical reagents and material inventory reports.
Qualifications & Experience
- Demonstrated competence with specific unit operations; typically focused more narrowly on upstream and/or downstream operations.
- Educated to A Level standard or equivalent and significant related experience in a cGMP and/or bioprocessing environment OR a Bachelor degree in a cell biology, chemical engineering, bioengineering or medical technology related field, or equivalent experience is required with some experience of manufacturing or pharmaceutical/Biotech aseptic processing.
- Ability to work independently and in a team setting.
- Ability to complete assigned tasks in a timely manner.
- Ability to resolve technical, material and cGMP problems that may impact project deadlines. Provides guidance and troubleshooting assistance as needed during a deviation in the process.
- Ability to be flexible with working hours e.g. able to work evenings/weekends and/or shifts if necessary for production schedules.
- Ability to stand for multiple hours and lift 20 pounds.
- Computer literacy including Microsoft Outlook, Word, Excel and Power Point.
- Experience in a GMP setting.
- Experience in a cGMP environment, or pharma / biotech manufacturing environment is preferred with focus on aseptic technique and tissue culture skills.
- Aseptic/ sterile techniques and prior experience working in a cGMP environment is preferred.
- Experience with biologic manufacturing (upstream and/or downstream) in a manufacturing, laboratory or academic setting is a plus.
Skills & Competencies
- Excellent verbal and writing communication skills
- Ability to work independently and work to a high standard
- Excellent team player—works well both within the team and with others outside of the team
- Positive, “can do” attitude
- Ability to work effectively with change and ambiguity
- Self starter
- Background in chemical engineering, bioprocess, microbiology or pharmaceutical sciences
Decision Making Authority
The job holder is responsible for analysing and reviewing raw data and bioprocessing equipment report. The job holder is responsible for training other operators in the designated area of expertise. Decision making and supervision of staff in the clean room on an occasional basis. The job holder is expected to take part to weekly team rota as per manufacturing schedule.
Additional “on-call” responsibilities may be taken on a voluntary basis.
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.