Sr. Manager / Associate Director, Platelet Biology
Manages laboratory staff and initiates, directs, and executes scientific studies for multiple projects for the INTERCEPT Blood System. Focus on internal studies used for product development and registration efforts.
- Manage day-to-day activities of laboratory staff including but not limited to scheduling, training and performance management.
- Act independently as Study Director: Experimental design, preparation of protocol, study execution, data analysis, and preparation of final report
- Perform platelet and coagulation in vitro assays
- Troubleshoot assays when needed
- Note trends and aberrations in data; identify problems and suggest/conduct experiments to determine root cause and develop solutions.
- Develop, validate and implement new analytical methods and technologies for project advancement.
- Serves as a technical expert on project teams, including contribution of ideas, developing plans, execution of the plan, and timely reporting of the results. Maintains high level of professional expertise through familiarity with scientific literature.
- Present data internally and at scientific conferences and contribute to scientific publications (abstracts and manuscripts).
- Work cross functionally with Clinical, Regulatory, Quality and Biostatistics departments.
- Perform other related duties as required.
- Ph.D. in a biology-related discipline preferred with a minimum of 7 years relevant experience or MS/MA in a biology-related discipline with a minimum of 12 years relevant experience; BA/BS required with a minimum of 14 years relevant experience.
- People management experience required.
- Experience with GLP, GMP, GCP or CLIA regulations necessary.
- Experience in product development.
- Expertise in flow techniques (FACS) desired
- Experience in fluorescence microscopy desirable.
- Experience with platelet and plasma coagulation desirable
- Working knowledge of blood bank practices desirable.
- Proficient in writing reports, regulatory submissions and publications.
- Ability to make decisions on the validity and importance of experimental results, the potential success or failure of activities within their area of expertise.
- Excellent mathematical skills, problem solving skills, and ability to apply scientific methods to resolution.
- Highly organized with strong attention to detail and accuracy
- Flexible; ability to adapt to changing priorities.
- Solid communication skills (verbal, written, interpersonal).
- Solid experience with related computer software.
- Ability to work independently and as part of a cross-functional team.