Reporting to the Quality Control Manager, you will be responsible for the development and qualification of analytical methods, the successful transfer from internal or external customers to QC together with the management of company Stability Studies and outsourced analytical activities.
Formed in 2010, ADC BIO have recently secured significant investment that is enabling a new dedicated 6500m2 facility in Deeside to support the rapid expansion plans of the Company.
To support this growth, we are recruiting a QC Technical Specialist who has the knowledge, experience and passion to help provide a world class analytical testing service.
The ideal candidate must have a demonstrable experience in the analytical testing of Biological Pharmaceutical products, Therapeutic Proteins or Monoclonal antibodies and possess the technical knowledge to support the development and qualification of suitable compliant assays in a regulated environment.
The key responsibilities will include:
- Ensure that analytical methods are developed to meet customer requirement and to allow their use within the cGMP Quality control testing department.
- Ensure that analytical methods are transferred from internal departments or external customers following customer, company and regulatory/industry requirements (cGMP).
- Ensure that all equipment and methods are suitably qualified (Phase appropriate ICH guidelines.) for use in cGMP testing of raw materials, in process samples, and products.
- Author and review laboratory protocols and reports, validation studies and project work.
- Manage Stability studies to ensure testing is performed in compliance with customer, company and regulatory/industry requirements (cGMP), and are reported within the most efficient timeframes.
- Manage the shipment to and analytical testing of raw materials, in process samples, and products by outsource partners
- Maintain and improve knowledge of analytical techniques and contribute to providing new and improved methods of working or equipment and to provide trouble shooting and problem solving to resolve issues in a timely manner.
- Liaise with maintenance staff and suppliers to ensure laboratory equipment and services are maintained to a high standard and in good working order.
- To assist in the performance and reporting of analytical testing on raw materials, intermediates and finished products following customer, company and regulatory/industry requirements.
- Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
- Assist QA in the performance of internal and external audits as required.
- Ensure the compliance of all laboratory procedures and personnel with all Health & Safety Guidelines, with reference to COSHH and Biological Safety Regulations and Health & Safety at Work Act 1974.
- Contribute to team building, training and problem-solving initiatives internally and cross site.
- Represent QC on project teams and in meetings to provide subject matter expert method qualification and stability knowledge.
Skills & Qualifications Required:
- Degree or equivalent qualification in a relevant chemical or biological subject area.
- At least 4 years’ experience in an analytical testing laboratory and experience of working in a pharmaceutical controlled environment is essential.
- Essential knowledge of regulatory requirements (pharmacopeia, ICH, cGMP) for Analytical validation, equipment Qualification, and Transfer of Analytical Assays
- Good understanding and application of cGMP and regulatory requirements (ICH) for Stability Testing of Pharmaceutical Products
- Working knowledge and expertise in the various analytical techniques to include HPLC, UV, FTIR, Titration, TOC, KF, CE, IEF, ELISA, SDS PAGE, Cell based bioassays.
- Excellent communication / interpersonal and organisational skills, demonstrating attention to detail.
- Be a team member and proven project management skills.
We award our teams with a highly competitive remuneration package which will be discussed at interview stage with salary expectations of c. £30k p.a plus other benefits including a generous holiday entitlement of 25 days plus 8 bank holidays plus a Xmas shut down – (if applicable 3 days gratis holiday during that period) and a 3% contribution to a workplace pension (Peoples pension).
In the first instance, please attach your CV and current remuneration details/expectations together with a brief covering letter.