Senior Scientific Director, Flow Cytometry

Position Summary:

The Senior Scientific Director, Flow Cytometry will use their scientific expertise to lead development and validation efforts for Flow Cytometry assays to support multiple fast-paced clinical and non-clinical studies for clients engaged in cutting-edge research. As a team leader with direct reports, the person will train and mentor staff to ensure scientific rigor and use their expertise to guide assay development and troubleshooting. The position requires direct experience in all aspects of regulated and non-regulated cellular assays and must have working knowledge of all current regulatory guidance and industry best practices. The person will also engage with QA to maintain regulatory compliance and work with project managers to ensure timely and efficient client communication. Lastly, the ideal candidate will have experience hosting and/or participating in regulatory audits.

Essential functions of the job include but are not limited to:

• As Head of laboratory, this position is fully responsible for all scientific activities, regulatory compliance, staff, and metrics associated with clients and product delivery.
• Mentor and lead all scientific staff assigned to Flow Cytometry assays, including receptor occupancy and internal and external cellular markers. Ensure proper method development and validation of projects so they are quality-driven and executed against communicated timelines and milestones.
• Direct scientific staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects and client studies.
• Participate actively in the Flow Cytometry community to ensure Precision is fully aware of all relevant guidance for regulations pertaining to Flow Cytometry.
• Serve as Technical Lead and Subject Matter Expert for all Flow Cytometry Assay Projects.
• Serve as Project Director or Principal Investigator as required.
• Lead the scientific team in the design and execution of all experiments, ensure all data is accurately analyzed, quality-driven, and delivered to clients on time.
• Communicate clearly, both written and verbal, and often with clients and ensure product delivery is within client expectations for all projects associated with Flow Cytometry assays.
• Lead the team in establishing, writing, reviewing, and/or improving all procedures, SOPs, POPs, study protocols/plans, assay validation/verification, and associated reports.
• Identify, update, and implement emerging laboratory techniques and/or instrumentation.
• Work collaboratively with other technical teams in resource sharing and providing technical expertise.
• Write and prepare abstracts, techniques, and/or draft scientific papers to maintain the scientific standard and image of the company.
• Present completed work at appropriate scientific meetings and in publications as needed.
• Troubleshoot and correct routine scientific issues and problems in a timely manner.
• Act as a scientific resource externally to clients and internally on Product and Services/R&D-related projects.
• Assist with writing, reviewing, and editing contract and grant applications/proposals as appropriate.
• Maintain and support safe lab practices and environment.
• Carry out other duties/projects as assigned.

Qualifications:

Minimum Required:

• PhD in life sciences or a relevant life sciences field and at least 18 years of full-time relevant laboratory experience, or an equivalent combination of education and experience.
• 10 years of management experience.
• Solid understanding of current GxP or CAP/CLIA/ISO standards.
• Previous work experience in GLP, GCLP, or CLIA regulatory compliance.

Other Required:

• Expert-level human Flow Cytometry assay experience.
• Experience handling various sample types such as plasma, serum, and PBMCs.
• Experience developing Flow Cytometry panels on fresh and fixed cells.
• Solid understanding of current method validation standards.
• Excellent communication, interpersonal, and organizational skills.
• Ability to organize and analyze data and prepare reports.
• Strong computational skills, preferably with experience using Word, Excel, PowerPoint, Gen5, and GraphPad Prism.
• Excellent judgment and discretion.
• Extended work hours may occasionally be necessary to meet business demands.
• Ability to lift and carry between 1 and 15 lbs.; ability to lift up to 50 lbs. overhead with assistance; frequent sitting, grasping, and use of right/left finger dexterity; may be exposed to cold freezer environments ranging from -20°C to -196°C.
• Must be able to read, write, speak fluently, and comprehend the English language.

Compensation and Benefits:

The estimated compensation range is $203,200-$304,800 USD. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.