Summary of Bio-Analytical Scientist role
We are recruiting a Bio-Analytical Scientist who has the knowledge, experience and passion to help provide a world class analytical testing service.
The successful candidate will have demonstrable experience in the analytical testing of biological pharmaceutical products, such as therapeutic proteins, monoclonal antibodies and Antibody Drug Conjugates (ADC's), and will possess the technical knowledge to support the development and qualification of suitable compliant assays in a regulated environment.
- Assisting in the development and qualification of HPLC, UV and capillary electrophoresis-based assays for antibodies and antibody drug conjugates (ADCs).
- Performing and reporting analytical testing on all raw materials, intermediates, finished products and stability samples in HPLC, UV and capillary electrophoretic methods.
- Performing analytical testing, following the completion of training and qualification, using a variety of techniques including:
- Pharmacopoeial physicochemical methods;
- HPLC (SEC, HIC, PLRP, CEX);
- Imaged capillary electrophoresis; iso-electric focusing; SDS CE;
- Spectrophotometry; FTIR and UV - vis;
- Performing routine tasks and other non-routine activities required in support of analytical development and quality control laboratory functions.
- Ensuring all testing performed is reported within the most efficient timeframe.
- Laboratory maintenance and housekeeping, self-inspections and stock control; supporting the re-order systems and communicating with key suppliers.
- Data trending and assisting in quality investigations.
- Documenting laboratory results in accordance with cGMP and company procedures.
- Ensuring training status is compliant with matrix requirements and assisting in training other laboratory staff.
- Maintaining and improving knowledge of bio-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 Analytical Services/Quality Control as appropriate to ensure projects are progressed.
- Preparing and executing laboratory protocols and reports, as assigned.
- Qualifying reagents, reference material, analytical techniques and relevant equipment.
- Ensuring 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.
Key Skills and Competencies
- BSc or equivalent qualification in a relevant biological subject area.
- Experience of 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 is preferred.
- Technical experience in HPLC analysis or capillary electrophoresis analysis of biomolecules is essential.
- Technical experience in techniques such as immunoassays, UV and FTIR is an advantage.
- A good understanding and application of cGMP and regulatory requirements including USP, PhEur, orange guide and current 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, Perkbox, cycle to work, 25 days' annual leave, 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.
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.
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