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.

Responsibilities

* 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





 

• Contact: Katie Pink
• Reference: Totaljobs/BBBH4465
• Job ID: 66864401