Microbiology Team Leader

Location: Deeside, Wales, UKDepartment: QualityReference: VN137
Microbiology Team Leader.

Summary of Microbiology Team Leader Role

An experienced microbiologist is required to manage a small team within the Quality Control (QC) and Analytical Services (AS) Department at the Deeside Site. The Team Leader will be responsible for the provision of a timely and compliant microbiology service to support both on-site development and manufacturing operations.

Responsibilities
 
  • Ensure microbiological and endotoxin testing is performed and reported in a timely manner on raw materials, intermediates and finished products following customer, company and regulatory/industry requirements. 
  • Coordinate, support training and lead Environmental Monitoring (EM) and water monitoring to ensure sampling operations are performed and reported in accordance to regulatory/industry standards.
  • Ensure that identification of any microbial/fungal isolates to the correct level are reported within an efficient timeframe. 
  • Initiate, manage and track the progress of deviations within own area to ensure that they are closed within the required timelines and to agreed standards.
  • Maintain all stock of media and consumables to ensure continuous testing capability within budgetary constraints. 
  • Manage the day to day activities of the laboratory, ensuring a timely, effective and compliant operation in support of manufacturing operations, including non-conformance reviews and implementation of corrective actions. 
  • Draft and review laboratory protocols and reports, validation studies and project work. 
  • Maintain and improve knowledge of techniques and contribute to providing new and improved methods of working or equipment.
  • Liaise with maintenance staff and suppliers to ensure laboratory equipment and services are maintained to a high standard and in good working order. 
  • Interface with Manufacturing and Engineering to ensure facility and utilities are operating in a controlled state.
  • Ensure that suitable written records and work undertaken are kept in accord with current Good Manufacturing Practice (cGMP) and company procedures. 
  • Assist Quality Assurance (QA) in the performance of internal and external audits as required. 
  • Ensure the compliance of all laboratory procedures and personnel with all Health & Safety, Environmental Guidelines, with particular 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 microbiological knowledge and experience. 
  • Embody our company values, which are: be reliable, be caring, be transparent and be willing.

Key Skills and Competencies
 
  • Degree or equivalent qualification in a relevant subject area.
  • Minimum of 4 years’ experience working within a microbiology laboratory and experience of working in pharmaceutical controlled environments is essential. 
  • Good understanding and application of cGMP and regulatory requirements including USP, PhEur, Orange guide and Current ICH guidelines applicable to the role.
  • Experience of working and monitoring of clean rooms and Utlities e.g. Water for Injection (WFI).
  • Demonstrated knowledge and experience in the testing and validation of Bioburden and Endotoxin Methods.
  • Experience of microbiological identification techniques e.g. Gram Staining, Staphylase, Oxidase test, and Vitek etc.
  • Excellent communication / interpersonal skills.
  • Excellent organisational skills. 
  • Ability to work accurately and with Attention to detail. 
  • Be a team member and demonstrate leadership skills. 

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. 

Sterling is an equal opportunity employer. 

Be caring. Be transparent. Be willing. Be reliable.
 
Service. Passion. Science.