- Reference: GY44434
- Job Type: Permanent
- Location: Mayo
- Category: Science, Pharmaceutical & Food
The Director of Laboratory Operations directs and oversees the laboratory operations in Ireland which includes the Analytical and Technical laboratories (ATL) & Microbiology. The Director will work collaboratively with the site leadership team to ensure the company strategic objectives are achieved.
This position will have responsibility for the overall management and quality of laboratory services at the site and will work cooperatively with Director of Quality Operations, Director of Technical Operations, Materials & Manufacturing Functions to deliver a quality laboratory service.
- QC Release testing of manufactured products and raw materials including, analytical chemistry and Microbial analysis to meet testing requirements to support site manufacturing operations.
- Stability Program Management: Batch selection and study initiation. Management of stability data trending and reports investigation of determined failures
- Management of Laboratory Investigations in collaboration with Operations, QA and pharmaceutical development
- Liaising with Regulatory Agencies for the management of stability investigations impacting commercial product
- Administration of laboratory electronic systems & records. LIMS & Empower system administration
- Utility and environmental monitoring programs
- Primary and Secondary Reference Standard Qualification
- Provision of laboratory services in support of the sites strategic projects and New Product Introductions
- Oversight of contract testing laboratory facilities utilised by the company.
- Provision of laboratory data in support of regulatory submissions
Skills, Experience and Qualifications:
- Advanced degree in Analytical Chemistry, Biochemistry, Microbiology or related laboratory technical disciplines.
- At least 7 years’ experience in Laboratory Management in Pharmaceutical testing facility.
- Exhibits knowledge of all applicable regulatory standards. Must be fully versed in GMP’s, ICH Guidelines, pharmacopeial testing standards, FDA, EU and other regulatory agency requirements for the operations of analytical, bioassay, microbiology, development and stability functions
- Ability to interact with peers, subordinates and senior personnel in multidisciplinary environment including quality, manufacturing, technical operations, engineering, regulatory affairs and validations.
- Demonstrated success leading a team of varying levels of technical expertise
- Exceptional planning, organisational and analytical skills. Ability to change direction and handle multiple priorities, projects and responsibilities on a regular basis.
- Displays excellent analytical and problem-solving capabilities.
- Demonstrate a strong quality focus with a drive to achieve excellence and promote continuous improvement.
- Experience successfully interacting with Health Authorities such as FDA & HPRA.
For a confidential discussion and more information on the role/company please email your CV to: email@example.com