Job title: Senior Analytical Services Scientist
Reporting to: Interim Head of Analytical Services
Department: GMP
No of Direct reports: 1+
Location: Bristol

SUMMARY:

eXmoor helps clients with their manufacturing of cell and gene therapies (CGT) and biopharmaceuticals. We provide; (1) translation consultancy to close the gap between R&D and clinical manufacture, (2) process development services from our wet labs in Bristol and (3) capital project design through to licensing and (4) licensed GMP manufacturing for early phase clinical trials.
The Senior Analytical Services (AS) Scientist will support the Head of GMP in establishing, managing and maintaining the GMP analytical Quality Control function.
This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants and engineers. You will work on a wide range of Client projects in a rapidly growing business whilst developing your quality management career.

JOB DESCRIPTION:

The GMP manufacturing facility will be capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The eXmoor facility will comprise three technical areas (Process Development (PD), shared AS including QC & GMP clinical phase production), both working closely together such that processes developed in the PD/AS area will be transferred at scale to the GMP suites and GMP QC.
The Senior AS Scientist will be responsible for managing and maintaining the GMP QC analytical function ensuring the laboratory and QC testing for materials and products meets its requirements under the MIA (IMP) licence and ensuring support for the AS function, whilst maintaining appropriate segregation between the two activities.

ESSENTIAL QUALIFICATIONS & EXPERIENCE:

• Minimum BSc level education in a relevant subject area or equivalent experience

Considerable experience (3 years plus) working within GMP Quality and QC operations, equipment qualification, quality and GMP documentation.

• Experience in leading a small team of scientists in a supervisory role. This includes the ability to lead, develop, motivate, and organise a small team.
• Understanding of Good Manufacturing Practice as applied to small scale biopharmaceutical production for clinical trials.
• Technical expertise in the analytics related ATMPs including but not limited to, HPLC, FACS and PCR.
• Understanding and experience of the following processes:
• ​​PQS systems such as deviations, change management, risk management, OOS, audits/self Inspections and product complaints
• ​C&GT analytics related to the assay, purity, identity, safety and potency of drug products.

DESIRABLE QUALIFICATIONS & EXPERIENCE:

• In depth understanding and experience in the establishment and management of Pharmaceutical Quality System and QC function.
• In depth understanding and experience of technologies used in the analysis of cell and gene therapy products including FACS, HPLC and PCR
• Knowledge of Good Laboratory Practice (GLP) and routine in-process and QC assay techniques such as HPLC, PCR, sterility testing, mycoplasma testing, ELISA, SDS PAGE.
  Qualified Person with experience in the certification of ATMP products

As a Senior AS Scientist you will have the following main areas of responsibilities and duties:
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