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Research & Development Laboratory Manager
4 months ago
The Research & Development Laboratory Manager ("R&D Lab Manager") is responsible for managing and supervising activities in the R&D laboratory to help achieve CND's commitment to scientific excellence while complying with all CLIA licensing and other regulatory requirements. As a key member of the R&D department and laboratory, the R&D Lab Manager oversees and ensures the effective execution of all daily laboratory operations to ensure study, project, and experimental success while ensuring compliance and quality. The R&D Lab Manager leads, manages, and develops laboratory staff including scheduling, assignment delegation, training, and performance evaluation. In collaboration with the Director of Research Operations and Senior Manager of R&D, the R&D Lab Manager plans for and conducts the onboarding of new projects and studies into the laboratory. He/she also collaborates with multiples members of the CND team, including but not limited to managers of the commercial testing laboratory, Quality Director, Chief Medical Officer, and Chief Scientific Officer. Additional responsibilities and tasks as assigned.
Job Responsibilities:
- Coordinate and manage activities and programs within the laboratory while ensuring CLIA, ISO, safety, quality, and other applicable and related standards
- Manage records associated with all activities and programs, as necessary
- Provide technical support for laboratory equipment and supplies, as necessary
- Maintain knowledge of all relevant protocols, regulations, standards, and safety procedures as well as developing and maintaining compliant standard operating procedures
- Manage personnel functions including interviewing, selecting, training, supervising, evaluating performance, and/or developing staff, work schedules, and assignments
- Organize and facilitate routine laboratory meetings
- Oversees inventory management including purchasing, storing, and allocating of laboratory equipment and supplies
- Responsible for laboratory equipment and supplies including but not limited to inspecting, maintaining, and/or troubleshooting
- Perform and document routine quality assurance and preventive maintenance
- Manage and support reports pertaining to the laboratory
- Assist in the preparation of budget estimates, as necessary
- Perform various technical duties in support of research activities including but not limited to sample preparation and processing, quality control, quality assurance, etc.
- Support routine processing of samples associated with ongoing research projects
- Support and assist with onboarding new studies and projects into the R&D laboratory
- Assist with the design, execution, documentation, coordination, and evaluation of research experiments and studies including but not limited to process improvement and product development endeavors, as necessary
- Support the implementation of validated process improvements and developed protocols
- Collaborate with and/or serve as a liaison to agencies, administrators, departments, and/or stakeholders during internal and external audits
- Maintain, update, and distribute information regarding protocol, manual, and other updates/changes
- Help manage the overall facility, plan for the necessary capacity, and lead build out projects
- Maintain excellent laboratory skills, GLP, GDP, and communication skills
- Perform other related duties and responsibilities as assigned
Knowledge, Skills & Experience:
- Minimum of 10 years laboratory experience in an equivalent laboratory setting (histopathology, anatomic pathology, etc.) required
- 2-4 years of supervisory experience required including at least one assignments as the onsite laboratory manager of a CLIA-certified lab
- Significant experience working in and/or managing an anatomic pathology lab as well as blood-based lab preferred.
- Strong aptitude for experimentation and optimization
- Excellent laboratory and documentation practices and skills, analytical skills, and QA/QI capabilities.
- Familiarity and competency with good laboratory practices, good documentation practices and experimental design.
- Knowledge of basic laboratory practices and dynamics.
- Strong interest in working in a start-up environment and the ability to take on a range of tasks simultaneously and effectively.
- Excellent collaboration, communication, and presentation skills.
- Strong attention to detail and a commitment to quality work, including achieving assigned timelines for deliverables.
- Proactive work style and willingness to take initiative (with proper guidance from leadership).
- Professionalism and dedication to respecting colleagues, customers, partners, vendors, and other stakeholders.
- Desire to learn and develop professionally.
Education, Certifications & Licensures:
- Bachelor's degree in a related scientific field/area required (Biomedical engineering, Biomedical Sciences, Biology, Biochemistry, etc.)
- Master's degree in a related scientific field/area preferred
Physical Demands:
- Combination of seated and standing work to complete the core functions of the role.
- Sit and stand for long periods of time.
- Visual acuity and analytical skills.
- Must perform repetitive motions.
- May have exposure to fumes and bio-hazardous materials in the laboratory environment.
- Handling of general laboratory reagents.
