Validation Microbiology Team Leader -Stability-Hants-£26k-£30k

Hampshire, England
GBP26000.00 - GBP30000.00 per annum
Oct 11, 2016
Nov 08, 2016
Katie Pink
Result Type
Position Type
Full Time

Validation Microbiology Team Leader -Stability-Hants-£26k-£30k

A global biotech organisation is seeking an experienced Validation and Stability Team Leader to join its Hampshire site. You will manage the workload of 3 microbiology technicians, leading all stability and validation operations. You will be an experienced microbiologist, ideally with prior supervisory experience. You must have experience of product stability validation.

Position Summary:

*To organise the product stability testing programme for specified MBD products, intermediates, third party products, new and redeveloped products.
*To lead the laboratory team of bench scientists responsible for all laboratory work associated with product validation and product evaluation.
*To review validation data and produce reports for both internal and customer use.
*To manage product evaluation projects.
*To review validation data and advise manager of all necessary actions.
*To plan and manage the team in line with agreed budgets and goals.


*To manage and develop the stability programme for MBD products, reporting project information and progress to the Quality Manager.
*To prepare Compliance SOPs and product testing protocols in accordance with customer requirements (internal and external) regulatory guidelines and company requirements.
*Carry out the testing programme using protocols in accordance with regulatory guidelines and company requirements.
*To organise and undertake additional product validation and product evaluation as required
*To alert manager of potential product issues and assist in corrective actions where required.
*To monitor team performance against plan and take action where target could be missed.
*Act as main contact for product specific validation enquiries for the business.
*Provide validation reports for internal and external customers
*Prepare validation plan with stakeholders, Prepared Media Sites and ensure that they are informed of progress.
*Ensure effective communication and liaison with Export Regional Managers regarding product registration.
*Carry out customer site visits when required by Sales team.
*Provide validation expertise to product risk assessment process.
*Manage storage of products under required conditions and ensure that the correct conditions are maintained throughout storage period and that accurate records are kept.
*Assist in audits and clearing non conformities.
*Manage Compliance deviation process for specified product groups.
*To manage team including performance reviews with assistance from Validation Manager.
*To undertake training of new and existing personnel as required.
*To fulfil the responsibilities of the position as defined in the Health, Safety and Environmental policies and associated Codes of Practice.
*To actively promote Health & Safety awareness of all other employees and to help maintain a safe working environment.

 Minimum Requirements/Qualifications:

*Must be educated to minimum of a BSc in a Microbiology related subject
*Proven experience in Microbiology laboratory preferable expertise in Culture Media.
*Experience of product stability validation.
*Team management experience.
*Good planning skills.
*Willingness to travel where required.
*Good working knowledge of Word, Excel and SAP.
*Good communication skills with all levels within the business