Kelly Services are recruiting for an experienced Analytical Technical Manager for a life science company based in their Biologics Division located in Ballina, Co. Mayo, Ireland. Reporting to the Head of Analytical Strategies, this role will be responsible for overseeing different analytical project (e.g. Method Development, Optimization, Qualification and Validation). A team of 6-8 Project Leaders will report to this role.
This main duties & responsibilities shall be:
- Assist Project Leaders with client study plans and the execution of studies in strict accordance with study plan and SOPs ensuring full GMP regulatory compliance, where appropriate.
- Research and develop new analytical methodologies to meet client requirements and/or company strategic objectives.
- Ensure all new methods are validated in accordance with ICH guidelines or other regulatory requirements, where appropriate.
- Oversee the quality of work produced by the team and ensure it is conducted in accordance with Standard Operating Procedures and the principles of GMP.
- To implement and supervise safe working methods within the team and to inform and instruct staff of these. Comply with all Health and Safety regulations and procedures.
- Responsible for providing feedback on their performance to project leaders working on Client specific projects.
- Be involved in preparing costings and proposals based on protocols/project plan of proposed work by clients.
- Assist in the transfer of methods from clients to the Analytical Services Department where appropriate.
- Participate in regulatory and client audits and liaising with clients as required.
- Assist Project Leaders in research technical information for incoming new enquiries.
- Responsible for compiling audit responses in conjunction with the team and the Analytical Functional Manager.
- Responsible for supporting staff with deviations and laboratory investigation reports.
- Responsible for preparing 'Technical Presentations' and the delivery of same to the Analytical Services Department team and to Clients as required.
- Liaise with consultants and external services (e.g. subcontract laboratories) as appropriate.
- Responsible for reporting project leaders progress information to Management.
- Provide technical support to scientific team, as required.
- Day to day liaison with clients regarding current and new projects.
- Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
- Generate new and update current standard operating procedures and risk assessments for various projects as required.
- Responsible for purchasing new equipment as required.
The following are minimum requirements related to the Analytical Technical Manager position.
- PhD in a relevant science discipline (e.g. Chemistry, Biochemistry or Biotechnology)
- A minimum of 5-7 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
- Proven track record of supervising/managing staff.
- Experience in method development and validation of analytical techniques essential.
- Ability to problem solve and work on own initiative.
- Excellent communication and organizational skills.
- Ability to project manage multiple projects.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.