Analytical Services (AS) Scientist

eXmoor Pharma Concepts Ltd; Bristol; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading cell and gene therapy CDMO in Bristol is seeking an Analytical Services Scientist to conduct analytical assays and support GMP processes. Key responsibilities include maintaining lab equipment, drafting SOPs, and adhering to GMP standards. Applicants should have a relevant BSc degree and over a year of experience in a regulated laboratory environment. Strong organizational and communication skills are essential, along with familiarity in analytical procedures such as HPLC and qPCR.

Qualifications

• Minimum BSc degree level in relevant subject area or equivalent experience.
• Experience (>1 year) of working in a regulated and controlled laboratory area.
• Understanding of GMP and working within an analytical function.
• Experience of working within a QMS.

Responsibilities

• Run assays according to approved procedures and report data.
• Maintain and calibrate the analytical equipment.
• Draft SOPs and forms for the conduct of assays.
• Supervise engineers during maintenance visits.

Skills

HPLC

FACS

qPCR

ELISA

Organisation

Communication

Problem solving

Office365

Education

BSc degree in relevant subject area

Job description

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. The GMP manufacturing facility is capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The facility covers two technical areas (Process Development (PD) & GMP clinical phase production with an Analytical Services team supporting both Development and GMP), both working closely together such that processes developed in the PD area will be transferred at scale to the GMP suites. The AS Scientist will be responsible for conducting analytical assays in support of manufacturing and product release. The AS Scientist will also be responsible for supporting the development of methods and performing testing of process development samples in support of PD projects. The AS Scientist will be involved in the execution of validation protocols and collation of data to support method establishment for GMP programmes.

Responsibilities

Testing

• You will run assays according to approved procedures and reporting of data
• You will maintain and calibrate the analytical equipment
• You will prepare buffers to be used in assays
• You will prepare reference standards
• You will be responsible for receipt, labelling and storage of samples
• You will qualify assays and reference standards
• You will perform routine environmental monitoring in cleanrooms
• You will prepare samples for shipment
• You will release raw materials

Analytical Services Laboratory

• You will support the AS team in maintaining the laboratory area including maintaining stock levels and area cleaning
• You will order consumables and reagents
• You will supervise engineers during maintenance / calibration visits

Documentation

• You will be responsible for drafting SOPs and forms for the conduct of assays

Training

• You will be responsible for maintaining your training

Safety

• You will conduct your duties to the highest quality standard and in a safe way complying with all policies and procedures and with due care and attention for yourself and your peers.
• You will comply with GMP and laboratory documentation including risk assessments, SOPs, COSHH forms, lab notebooks and records.

Qualifications

• Minimum BSc degree level in relevant subject area or equivalent experience
• Experience (>1 year) of working in a regulated and controlled laboratory area
• Experience in analytical procedures such as HPLC, FACS, qPCR, ELISA (experience in all not an absolute)
• Ability to report data accurately and completely
• Experience in following approved procedures
• Understanding of GMP and working within an analytical function, development of analytical methods
• Writing analytical procedures
• Experience of working within a QMS and raising deviations, OOS reports etc.

Competences Required

• Organisation, planning and time management
• Oral and written communication skills
• Strong team worker
• Innovation, inquisitiveness, and willingness to learn
• Attention to detail and getting things finished
• Problem solving
• Proficiency in Office365 (including Word, Excel, PowerPoint)

eXmoor Pharma is the only integrated cell and gene therapy CDMO with over 20 years of consultancy expertise embedded across every stage of the CMC journey - from early-phase strategy to process development, GMP manufacturing and commercialisation. We provide comprehensive support across Viral Vectors, Autologous and Allogeneic Cell Therapies, and RNA technologies. This integrated model enables seamless progression from early-phase strategy through to commercial readiness.