Analytical Scientist (Bioassay)

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.

Responsibilities

• Developing and qualifying cell-based potency 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

Key Skills and Competencies

• BSc or equivalent qualification in a relevant biological subject area.
• Previous experience in a cell biology laboratory 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.
• Competent with IT systems, particularly Microsoft Office including Outlook, PowerPoint, Word and Excel.

You will receive 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 opportunities for further career development.

This role is a shift role to support our 24/7 operation with annual leave and rest days built into the shift plan.

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services. We are a fast-growing, dynamic business with facilities in the UK and Ireland, where we employ talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.

Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.