TITLE AND CLASSIFICATION:Associate Director, Flow Cytometry Operations (TOS)
REPORTING TO: VP, Scientific Operations
PRIMARY OBJECTIVES: Oversee preclinical and clinical flow cytometry operations for the Client’s flow cytometry group. Provide technical expertise in flow cytometry. Responsible for maintaining high quality flow cytometry data generation and interpretation. Assist in the development and maintenance of a GxP compliant flow cytometry laboratory to support clinical trial sample analysis. Manage and develop staff. Oversee or delegate flow cytometry work, interacting directly with commercial team to ensure protocol adherence, provide status updates and assist with data interpretation and reporting. Generate novel methods to develop, transfer, and validate appropriate flow cytometry assays. Schedule staff to allow for work to occur as needed to ensure sample processing within stability timeline requirements. Ensure quality sample analysis, data QC and reporting within defined timelines in a fast-paced environment. Work with Business Development to assist in enquiries as needed.
DUTIES AND RESPONSIBILITIES
· Technical and general scientific expertise
o Deep understanding of flow to guide internal teams.
o Responsible for development of flow cytometry assays that are high in quality, accuracy, and repeatability.
o Ability to design panels, perform data acquisition and analysisin a fast-paced environment.
o Ability to transfer developed assays by writing methods and training staff, and by troubleshooting any assays performed in production that develop problems.
o Assist project leads with analysis of flow cytometry data and interpretation of results including preparation of reports.
o Responsible for the quality and efficiency of studies performed within the flow cytometry laboratory.
· Business and operational management:
o Responsible for managing and mentoring staff.
o Responsible for scheduling and planning to effectively manage workload.
o Participates in strategic planning for growth in flow cytometry
o Responsible for regulatory compliance of GxP within flow cytometry analytical operations.
o Serve as Lab Director for CLIA approved flow cytometry.
o Maintains CLIA compliance and approval.
o Responsible for HIPAA compliance
· Sales and marketing
o Works directly with business development and Clinical Operations teams.
o Assist business development by providing input into and review of enquiries and statements of work for large clinical and preclinical contracts.
KNOWLEDGE, SKILLS, AND ABILITIES
· Flow cytometry experience including panel design, method development, analysis, and interpretation of multicolor flow cytometry in multiple species including mouse and human.
· Experience with 16+ color flow cytometry.
· Experience with flow cytometry analysis software (FACSDiva, FlowJo preferably)
· Experience in immunology, oncology, and cell biology. Prior drug development experience helpful.
· Excellent planning, organization, computer, written and verbal communication skills.
· Ability to effectively network, negotiate, and influence different stakeholders at any business level
· People and operational management experience leading a team of professional staff productively in a team-oriented environment while maintaining a strong sense of integrity and confidentiality.
· Prior experience with lab oversight, including work scheduling, equipment maintenance, reagent inventory, sample throughput.
· Prior experience with regulatory analytical laboratory environments, including Quality Assurance, adherence to GxP, SOP writing, method validations, audit responses, and training and compliance.
· Prior experience with CLIA, CAP proficiency testing and/or NY State Department of Health Clinical Laboratory Evaluation Program
· Project management of clinical flow cytometry studies. GANNT charts, periodic update meetings with clients, and general oversight of clinical studies.
· Creative problem-solving skills and the ability to exercise sound and accurate judgment in making timely decisions.
· Demonstrated accountability and responsibility for own work.
· Ability to observe safety and security procedures.
· Proficiency with teamwork, multitasking, organization, written and verbal communication skills.
· Ability to assist with other tasks/duties as needed in a small company environment.
EDUCATION AND EXPERIENCE
· Ph.D. with 4+ years’ experience, M.S. with 7+ years’ experience, or equivalent experience in multicolor flow cytometry
· Previous experience managing research staff
· Previous experience in a regulatory flow cytometry operation
· Prior CRO experience helpful
· Oncology, immunology, and drug development expertise preferred
· GLP, GCP, CAP or CLIA experience required
· Up to 10% travel
This job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary.
Please contact Lisa Peterson 561-347-0446, 561-350-3900 or email@example.com for further details