Bioassay Analyst

Location: Deeside, Wales, UKDepartment: QualityReference: VN071
Summary of Bioassay Analyst role

The Bioassay Analyst will be responsible for assisting in the development and qualification of cell-based potency and ELISA/immunology-based assays for antibodies and antibody drug conjugate (ADC) products. They will also be  responsible for the routine testing of raw materials, intermediates , finished products and Stability Samples using the developed methods.

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 analytical 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 or microbiological testing, following the completion of training and qualification, using a variety of techniques including:
    • High performance liquid chromatography (HPLC), 
    • Imaged capillary electrophoresis
    • Bioburden
    • Endotoxin
    • Growth Promotion
    • Environmental monitoring
  • Performing routine tasks and other nonroutine activities required in support of quality control laboratory functions.
  • Ensuring all testing performed is reported within the most efficient timeframe.
  • 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.
  • Ensuring training status is compliant with matrix requirements and assisting in training laboratory and production staff.
  • 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.
  • Embody our company values, which are: be reliable, be caring, be transparent and be willing.

Key Skills and Competencies

BSc or equivalent qualification in a relevant biological subject area.
  • At least two years’ experience in a cell biology or microbiologytesting 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 is essential.
  • Technical experience cell-based bioassays and ELISA is preferred
  • Technical experience in techniques such as Bioburden, Endotoxin and Environmental Monitoring is an advantage.
  • Good understanding and application 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.

You will receive

A competitive salary, pension scheme, cycle to work, on-site health and wellbeing support, 24/7 employee assistance programme. Training and opportunities for further career development.

Why consider Sterling?

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 complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 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 opportunity employer.
Be caring. Be transparent. Be willing. Be reliable.

 
Service. Passion. Science.