Manufacturing Specialist,

6 months ago

Abingdon, United Kingdom Adaptimmune Full time

**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 purpose of the role is:

- To support the GMP start-up of the allogeneic manufacturing facility in Milton Park.
- To perform GMP manufacture of allogeneic products.

This role is a unique opportunity for an applicant to join our manufacturing team near the beginning of our journey. We have recently built a brand-new manufacturing facility for the manufacture of stem-cell derived allogeneic products. This role will have significant input and influence in supporting the creation, development, and continual improvement of processes and procedures needed to manufacture our stem-cell derived allogeneic product for clinical trials.
The ability to be both hands on in the manufacture of our products as well as lead critical paper-based work is essential for this role.
Responsibilities include the writing and reviewing of GMP documentation, operating bioprocessing equipment, performance of aseptic operations, executing routine cleanroom maintenance and supporting environmental monitoring.

**KEY RESPONSIBILITIES**
- Responsibility for drafting or modifying GMP compliant manufacturing documents with the appropriate oversight. These documents include but are not limited to material specifications, training records, SOPs, batch records, log books and validation documentation.
- Support the establishment, development and use of GMP processes and procedures throughout the new manufacturing facility.
- Perform allogeneic manufacturing related activities to aseptic cGMP standards (clean room attire required and provided). Operations may include cell banking, iPSC establishment, differentiation, T-Cell expansion, and fill/finish.
- 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.
- With support, author out of specification (OOS) reports, change controls, deviation investigations and corrective and preventative actions.
- Complete CAPA / improvement actions compliantly.
- Ensure the appropriate levels of cleanliness within the building and materials to be used in manufacturing.
- Supporting equipment and facility qualification, participating in development and engineering runs / experiments.
- Supporting facility GMP compliance activities.
- Supporting training and safety initiatives including any applicable GMP requirements for working in area.
- Supporting warehouse management as required to ensure material availability

**QUALIFICATIONS & EXPERIENCE**

**_Required_**
- Demonstrated competence within a GMP or regulated facility with a strong preference for experience working in a regulated cell culture laboratory.
- Educated to A Level standard or equivalent with experience in a cGMP environment OR a Bachelors degree in a cell biology, chemical engineering, bioengineering or medical technology related field
- Ability to complete assigned tasks to a high standard in a timely manner.
- Experience in supporting the resolution of technical, material and/or cGMP problems that may impact project deadlines.
- Experience in supporting deviation investigations and writeups.
- Ability to be flexible with working hours e.g. able to work evenings/weekends and/or shifts as necessary for production schedules.
- Ability to stand for multiple hours in a cleanroom environment and lift up to 9 kilograms unassisted.
- Previous experience working under aseptic / sterile conditions
- Computer literacy including Microsoft Outlook, Word, Excel and Power Point.

**_ Desirable_**
- Experience in a cGMP biologics manufacturing environment, with focus on aseptic technique and tissue culture skills.
- Experience working in Grade B cleanrooms
- Demonstrated experience authoring GMP documentation
- Allogeneic / cell culture experience

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