Company Information
Advent Bioservices is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using highly personalised therapies.
Job Summary
We are seeking GMP Production Scientists who are looking to advance their careers in the exciting and evolving area of cell and gene therapies.
As a GMP Production Scientist I, you will be part of our GMP manufacturing team, playing a key role in the production and delivery of cellular therapy products. Working within a Grade A-D cleanroom environment, you will be responsible for maintaining high standards of cleanroom operation and performing the manufacture of patient specific products using biological safety cabinets and isolators.
You will collaborate closely with colleagues across multiple departments to support the efficient and timely delivery of cellular therapy products for clinical use.
This role is a site-based role located at our Sawston facility. The role will initially be worked during standard business hours, with some flexibility required. As operational requirements develop there may be opportunities for alternative work patterns or shift arrangements such as staggered hours or shift patterns. Further details will be discussed during the recruitment process.
Responsibilities will include:
- Working under Good Manufacturing Practice and MHRA regulations
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Qualifying in Gowning, Transfer of Items and Operator Broth (Operator Aseptic Qualification) to enable you to manufacture cellular products.
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Cleaning of cleanrooms and equipment.
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Disinfection of items going into the cleanrooms (Transfer of Items Processes).
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Performing Environmental Monitoring of cleanrooms.
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Acting as an Operator, Support or Verifier in manufacturers (dependent on experience/ job seniority). This involves operating and working with cells in an open process inside a Grade A safety cabinet, or Grade B/C cleanrooms in closed system processing.
- Adhering to a Quality Management System (writing non-conformances, change controls, risk assessments and other GMP documentation).
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Use of digital platforms such as eBMR and Labware for documenting processes.
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Use of GMP equipment such as ROTEA, CRF and Liquid Nitrogen Dewars to process / freeze cell therapy products.
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Supervision and training of staff on processes.
You will have the following experience/qualifications:
- A Bachelors degree (or equivalent) in a science or related discipline. A Masters degree or experience in a cell therapy / pharmaceutical manufacturing environment is advantageous.
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Experience of cell culture techniques (essential).
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Experience in aseptic techniques (essential).
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Experience following validated SOPs and protocols (essential).
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Working knowledge of GMP for ATMPs and EU regulations for cell and gene therapy (essential).
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Experience manufacturing in a controlled clean-room environment at Grades A-C (desirable).
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Experience in writing reports, change controls, and reporting on deviations, non-conformances, and other quality events using a Quality System (desirable).
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Experience in automation and closed system processing (desirable).
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Ability to work in a team environment with excellent communication (essential).
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Ability to adapt to changing environments and to problem solve and make important decisions that affect vital products and services (essential).
We offer excellent opportunities for career progression along with training.
Candidates must be eligible to work in the UK.
We are not accepting agency applications for this role.
