Stability Team Leader

The Stability Team Leader is responsible for the day to day management of the company stability testing program for new and existing products, ensuring that stability time points are completed accurately, correctly, and in a timely fashion by the Stability team and analytical reports are reviewed and approved.

This is an ideal role for someone who has developed their technical skills and wants to move on to utilise those skills and manage a small team.

 

Key Responsibilities

▪ Planning and ensuring timely execution of weekly stability time points, ensuring

on time completion and accuracy, highlighting any issues to the Stability and

Method Validation Manager.

▪ Ensure appropriate levels are maintained of consumables, chemicals, reagents,

and standards for stability testing.

▪ Review and approve analytical test reports from the Stability Analysts.

▪ Develop, write and implement stability protocols with the necessary physical,

chemical, and microbiological tests.

▪ Carry out analytical work as required, to ensure time points are completed.

▪ To manage the outsourcing of external testing to contract laboratories

▪ Ensure the production and labelling of suitable samples for stability testing.

▪ Conduct out of specification investigations with the Stability Analysts as required

and implement any necessary corrective actions. Encourage timely completion.

▪ Help to make recommendations of product shelf life for new products, and to

confirm product shelf life for existing products, based upon stability results.

▪ Prepare stability reports when required.

▪ Ensure that the stability chambers are maintained, calibrated and validated.

▪ Assist with effective monitoring of the stability chambers and an out of hours

response from the team for dealing with alarms when out of specification

▪ Manage the Stability Analysts, set objectives, carry out regular performance

reviews and develop appropriate training plans.

▪ Assist with laboratory method and equipment validation and development

projects when required.

▪ Ensure the Data Integrity policy is followed by the team at all times.

▪ To carry out any other reasonable management requested task.

 

Person Specification 

Education / Qualifications

▪ Degree educated or above in a Science subject or qualified by relevant experience of stability testing

 

Skills and Experience

Essential

▪ Previous experience or knowledge of stability testing of medicinal, food, or cosmetic

products, able to write stability protocols

▪ Experienced in pharmacopeial and/or food supplement requirements

▪ Experienced in development and evaluation of product specifications

▪ Experienced in conducting Out of Specification (OOS) investigations

▪ Experienced in outsourcing of testing to suitable laboratories

▪ A good appreciation of Good Manufacturing Practice

▪ Strong report writing skills

▪ Proficient in Microsoft Excel

▪ Good attention to detail

▪ Practical and organised approach

▪ Hands on / active team leader and coach for the Stability Analysts

▪ Ability to plan and prioritise work according to business needs

Desirable

▪ Supervisory experience in a product development, analytical or stability laboratory role

▪ Previous experience of microbiological analysis or evaluation of results

▪ Experience in development of analytical methods for plant materials, vitamins,

minerals, and other food supplements

▪ Experience of HPLC/GC techniques

▪ Experience of Thin Layer Chromatography (TLC) techniques

▪ Experience of production processes for solids, liquids and creams