Laboratory Manager
The Analytical Chemistry Laboratory Manager will report to and work directly with the Department Head of Analytical Services, in conjunction with laboratory operations personnel and interface with sales and customer service.
Essential Duties and Responsibilities:
- Providing hand-on technical expertise in supporting routine and non-routine chemical and pharmaceutical testing in accordance to applicable regulatory requirements, including US FDA, EMA, and others
- Oversee training of laboratory assistants and research associates for laboratory tasks along with Study Directors
- Supervise laboratory workflow and project manage to requirements of each client/project, ensure project timelines are met, as well as identify, develop, and oversee continuous process improvements to maximize quality and efficiencies in the laboratory.
- Provide guidance in trouble shooting various analytical instruments such as; HPLC, GC, GC/MS/MS, ICPMS, and others, and interface with Metrology and Validation services on all equipment both existing, and onboarding of new instruments.
- Write, review, and update SOPs
- Manage and assign inventory management of all laboratory supplies and chemicals, and disposal requirements per the corporate H&S program
- Review and assist Study Directors and Quality Assurance Unit in closing out protocol amendments, deviations and work to ensure compliance with all applicable regulatory guidelines.
- Manage laboratory personnel to ensure project deadlines are being met and technical work is being completed to standards.
- Perform reviews and generate personnel development plans.
- Work with Study Directors regarding study requirements, protocol generation and provide assistance in data review and reporting.
- Interface and support the Sales organization, as required, and communicate with clients on related projects.
Minimum Qualifications
- A minimum of bachelor’s or Master’s degree in Analytical Chemistry preferred.
- 5-10 years bench level analytical chemistry experience, with at least 3 years demonstrated laboratory management experience
Other Desirable Skills and Experience:
- Excellent verbal and written communication skills
- Strong personal initiative
- Proficiency in Agilent systems, including Open Lab
- High degree of attention to detail and accuracy-corporate compliance
- Must have a solid working knowledge of GLP regulations in an analytical laboratory setting.
- Exceptional oral and written communication skills
- Ability to work in a high volume, fast paced environment.
- Successful leadership and management experience is required as well as a familiarity with the preclinical process, including method development and validation.
· This position is located in Bedford, MA.