Director of Laboratory Operations
Our client, a global pharmaceuticals manufacturer based in Connacht, now seeks a Director of Laboratory Operations who will be responsibility for all laboratory activities (Analytical and Microbiology labs) in support of all aspects of commercial, clinical and development activities.
The Director of Laboratory Operations provides strong leadership, strategic planning, and laboratory system oversight for the site.
The successful candidate will work collaboratively with the site leadership team to ensure the company strategic objectives are achieved. This hire will attend site leadership meetings ensuring effective implementation of site strategic plan.
Remit of this Director of Laboratory Operations role:
- This hire will be responsible and accountable for the effective fiscal management of laboratory operations across the site, to ensure prudent utilisation of resources. Including the development of the departmental operating budget according to established guidelines, meeting all target deadlines, providing competent, highly engaged staff to meet company and regulatory requirements.
- Also, this hire is accountable for the management of team activities and must show the competence to drive forward the laboratory processes at the site and the skills to ensure that the laboratories operate a continuous improvement program. The Director of Laboratory Operations will work collaboratively with the Executive Director of Quality Operations to ensure company goals and objectives, customer requirements and the regulatory obligations as per FDA, EU and other relevant regulatory bodies are adhered to.
Responsibilities of Director of Laboratory Operations:
- QC Release testing of the site's 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 site's 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
Requirements for Director of Laboratory Operations:
- Bachelor's Degree in Analytical Chemistry, Biochemistry, Microbiology or technical disciplines. Advanced degree is preferred, PhD is highly desirable.
- 12+ years' experience in Laboratory Management in Pharmaceutical testing facility.
- Proven technical and management experience in GMP's, ICH Guidelines, pharmacopeia testing standards, FDA, EU and other regulatory agency requirements
- Proven experience in the operations of analytical, bioassay, microbiology, development and stability functions.
- Proven ability to work with 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.
- 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 further details, please contact Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. http://www.rftgroup.ie/
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