We have a newly created opportunity available for a Analytical Services Manager to join a growing pharmaceutical company based in the Leicestershire area.
As the Analytical Services Manager you will be responsible for the leadership and management of the Analytical department on the site to ensure that analytical operations are carried out in accordance with company policies and procedures, to effectively meet the needs of the business and to ensure compliance with GMP and regulatory requirements.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Analytical Services Manager will be varied however the key duties and responsibilities are as follows:
1. Ensure that adequate resources are employed to meet project timelines and be responsible for forecasting and addressing potential resource constraint issues. Monitor the progress of analytical work to ensure the efficient use of resources and compliance to project timelines. Act as a point of escalation for technical and non-technical issues arising within the Analytical department.
2. Provide regular updates to Quality and Technical Operations senior management on current technical issues, resource capacities, human resource challenges, personnel performance and delivery of departmental goals. Support the development of the goals/objectives for the Analytical department and ensure the delivery of these goals at the site. Actively review the implementation of the Pharmaceutical Quality System (PQS) within the Analytical department in order to ensure that activities are being conducted in a manner consistent with the stage of development for which work is being conducted.
3. Ensure the companies HSE policies and procedures are implemented and adhered to within the Analytical Department at the site. Oversee the Microbiological and Environmental monitoring programmes for the site. Collaborate with other Pharma Services laboratory groups to ensure harmonised processes and ways of working are maintained.
4. Assume a lead role in the auditing of analytical activities by customers, and support inspections by regulatory agencies, such as MHRA and US FDA. Manage the forecasting, procurement, installation, commissioning and maintenance of all laboratory equipment within the Analytical department. Manage the review and timely provision of stability summaries for regulatory submissions with appropriate trending and statistical analysis of results as required.
5. Support business development activities by providing regular capacity updates and technical support to proposal review/costing and Business Development visits. Support Senior Management in the development of the service offering from the site. Act as a key member of the Site Leadership Team (SLT) supporting the other SLT members in defining and delivering the overall site and business objectives.
To be successful in your application to this exciting opportunity as the Analytical Services Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in Analytical Chemistry, Chemistry of a life sciences subject with significant chemistry component. In addition, you will have significant management experience working in the pharmaceutical industry managing a large laboratory operation of multiple teams. Experience of managing large numbers of staff and dealing with general human resource challenges.
2. Significant experience of analytical method development, validation, stability study design and execution. Thorough knowledge of EMA and US FDA regulatory analytical and microbiological requirements for the development and manufacture of pharmaceutical drug products. Hosting analytical aspects of cGMP audits and regulatory inspections.
3. You will be a motivational leader, strategic thinker and a hands on manager.
Key Words: Analytical Services Manager | Analytical Chemistry | Pharmaceutical
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.