Jobs in Frederick, MD

About the role

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 ensure timely and efficient client communication. Lastly, ideal candidate will have had experience with hosting and/ or participated in regulatory audits. As Head of laboratory this position is fully responsible for all scientific activities, regulatory compliance, staff, and metrics associated with clients and product delivery.

What you'll bring

• PhD in life sciences or relevant field in life sciences and at least 18 years of full-time relevant laboratory experience or equivalent combination of education and experience.
• 10 years of management experience.
• A solid understanding of current GxP or CAP/CLIA/ISO standards.
• Previous work experience in GLP or GCLP or CLIA regulatory compliance.
• Expert level human Flow Cytometry assay experience.
• Experience in handling various sample types such as plasma, serum, and PBMCs.
• Experience developing flow cytometry panels on fresh and fixed cells.
• A solid understanding of current method validation standards.
• Excellent communication, interpersonal, and organizational skills required.
• Must have the ability to organize and analyze data, as well as prepare reports
• Must possess strong computational skills
• Excellent use of judgment and discretion required.