Analytical Scientist; Bioassay

Overview

Vacancy Name:
Analytical Scientist ( Bioassay)

Summary of Analytical Scientist ( Bioassay) role

As the Bioassay Scientist you will report directly to the Team Lead (Bioassay) and will assist in the development and qualification of cell-based methods from antigen, internalisation, potency and ELISA/immunology-based assays for antibodies and antibody drug conjugate (ADC) products. You will also conduct routine Quality Control testing of raw materials, intermediates, finished products and stability samples using the developed methods.

Our site in Deeside, North Wales is a short commute from Chester, Liverpool and Manchester and can be found lying alongside the waterways of the River Dee, presenting a quintessential glimpse of life in North Wales, with numerous nature parks, shopping centres and rural villages.

• Developing and qualifying cell-basedpotency and enzyme-linked immunosorbent assay (ELISA)/immunology-based assays for antibodies and antibody drug conjugates (ADCs).
• Performing and reporting of Quality Control testing on all raw materials, intermediates, finished products and stability samples in cell-based potency assays, cytotoxicity testing and immunological assays such as ELISA, following customer, company and regulatory/industry requirements.
• Performing analytical testing, following the completion of training and qualification, using a variety of techniques including:
  • Routine Cell culture
  • Cell Banking
  • MTS assay
  • ADCC assay
  • CDC assay
  • other cytotoxicity assays
• Performing routine tasks and other non-routine activities required in support of quality control laboratory functions.
• Laboratory maintenance and housekeeping, self-inspections and stock control.
• Data trending and performing quality investigations.
• Documenting laboratory results in accordance with cGMP and company procedures.
• Maintaining and improving knowledge of analytical techniques and procedures.
• Contributing to team building, training and problem-solving initiatives internally and across sites.
• Liaising with functional groups both within and outside quality control as appropriate to ensure projects and plans are progressed.
• Preparing and executing laboratory protocols and reports, as assigned.
• Qualifying reagents, reference material, analytical techniques and relevant equipment.
• Ensuring that all laboratory activities are in compliance with all health and safety guidelines, with particular reference to Control of Substances Hazardous to Health (COSHH), biological safety regulations and the Health and Safety at Work Act 1974.
• Embodying our company values, which are: be reliable, be caring, be transparent and be willing.

• BSc or equivalent qualification in a relevant biological subject area.
• Previous experience in a cell biologylaboratory and experience working in a regulated environment, pharmaceutical or medical laboratory in a related role to cGMP or within alternative quality system (UKAS/ISO 9001) such as a contract testing laboratory.
• Technical experience in aseptic techniques and cell culture is essential.
• Technical experience in cell-based bioassays (e.g. MTT, ADCC, CDC) and ELISA is preferred
• Technical experience in techniques such as Bioburden, Endotoxin and Environmental Monitoring is an advantage.
• Good awareness of cGMP and regulatory requirements including the United States (USP) and European (Ph. Eur.) Pharmacopoeias, orange guide and current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines applicable to the role.
• Excellent communication, interpersonal and organisational skills, demonstrating attention to detail and able to work in a team and individually.

We also require candidates to be competent with IT systems, and in particular Microsoft Office including Outlook, PowerPoint, Word and Excel.

A competitive salary, pension scheme, private healthcare, retail discounts through reward gateway, cycle to work, 26 days annual leave and bank holidays, death in service coverage, on-site health and wellbeing support and medical consultation and physiotherapy, 24/7 employee assistance programme. Training and…