About the position
The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer activities to develop BCG and future testing capability at the Durham site. The successful candidate will report to the Associate Director, Laboratory Operations to lead start-up new laboratories for microbiological testing and environmental monitoring. Method transfer activities will include qualification of equipment, facility and utilities. Successful start-up of the laboratory will require candidates to work cross-functionally with existing company Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using principles of our company's Production Systems, Lean Laboratories, and GMP requirements.
Responsibilities
- Work cross-functionally with internal company sites and global partners to build and operate testing capability within the Quality Laboratory Operations.
- Collaborate with internal customers and vendors to ensure successful execution of method transfer or method validation activities.
- Apply project management concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and budgeting.
- Build knowledge of the company, processes and internal/external customers.
- Build and maintain strong relationships with site leadership, stakeholders, and customers.
- Apply team effectiveness skills, listening and integrating diverse perspectives from across the work group.
- Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing.
- Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods.
- Trouble-shoot laboratory process and equipment issues as needed.
- Manage sample management and planning and test method execution to meet established delivery timelines.
- Provide active support during audits and inspections (regulatory, internal, safety).
- Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations.
- Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements.
- Support Manufacturing Divisional and Quality initiatives.
- Lead project team initiatives to ensure timelines are met and laboratories are prepared for routine product testing.
Requirements
- B.S. or M.S. degree in Sciences with a minimum of 5 years of laboratory experience.
- Experience with execution and trouble-shooting of microbiological testing.
- Experience in Environmental Monitoring, including sampling, testing, and reporting.
- Experience with aseptic handling techniques.
- Technical writing skills.
- Previous GMP laboratory experience.
Nice-to-haves
- Leadership experience.
- Experience in new assay development, validation, and/or technology transfer.
- Experience authoring technical documents supporting regulatory filings (FDA, EMA, JNDA).
- Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry.
- Experience in regulatory agency audits and/or regulatory filings.
- Experience with Lean Six-sigma and problem-solving tools.
