Position Summary:

The Executive Director / Site Head of Precision for Medicine (located onsite in Frederick, MD) will be responsible to oversee the laboratory operations across 3 different functional groups in Frederick, Maryland. This role is responsible for ensuring that lab environments, processes, and systems are optimized to enable scientific and operational excellence while maintain regulatory compliance. A critical requirement is deep current knowledge of FDA guidance documents and requirements, along with the ability to put these requirements into practice developing robust assays that easily pass FDA scrutiny. Experience with developing and managing programs following FDA/IVDR,. ISO 13485 and 15189 principles of design control, understanding of both CLIA and CLSI validation requirements, and assay execution of both cell-based and non-cell-based assays is required.  

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

• Full responsibility of operational aspects for all laboratories in Frederick MD; including Bioanalysis, Flow Cytometry and Companion Diagnostic.
• Support, hire, coach and mentor laboratory lab heads in Bioanalytical, Flow and CDx
• Collaborate with site supporting departments: Facilities, Biorepository, Quality Assurance, Finance, as well as other global site heads.
• Monitor and report site KPIs including quality events, turnaround time, capacity, revenue delivery and budget adherence.
• Is fully responsible for improving operations and enhancing operational excellence in each laboratory.
• Responsible for weekly and monthly revenue reporting, cost tracking and margin expansion.
• Provide operational excellence leadership ensuring that the team is efficient and has appropriate resourcing.
• Mentor and lead laboratory head for all applicable laboratories.
• Direct staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects
• Ensure all work is completed to the appropriate regulatory guidelines, CAP/ CLIA/ GxP.. etc..
• Work closely with QA and our regulatory team to ensure compliance to industry standards.
• Attend and actively participate in FDA calls regarding assay development and compliance.
• Ensures all development and validation study protocols and reports meet CAP/CLIA and CLSI requirements
• Establish and implement a communication strategy to ensure timely and consistent dissemination of information to engage key stakeholders across the site and within Precision.
• Communicate clearly with clients and manage client expectations for all projects within the teams
• Is responsible for establishing best practices for company business operations processes and systems to support growth and efficiencies.
• Prepare/review critical documents including protocols, reports, and SOPs as applicable: Oversee the establishing and improving of all procedures and required SOP documentation
• Oversee the team in relation to trouble shooting and correcting all scientific issues/problems within the teams
• Support all leaders in the review of data and provide written and verbal technical updates to clients as needed; be an escalation point for clients.
• Work collaboratively with other technical teams in resource sharing and providing technical expertise
• Act as a scientific resource externally to clients and internally on Product and Services/ R&D related projects
• Assist with writing, reviewing and editing contracts and scope of works, change orders.
• Maintain and support safe lab practices and environment
• Carry out other duties/projects as assigned

Qualifications:

Minimum Required:

• D. in Immunology or related field
• 12+ years’ relevant experience (at least 6 years in industry)
• 6+ year leadership experience

Other Required:

• Prior supervisory experience
• Direct working experience and knowledge in cell based assays / bioanalysis of large or small molecule used for supporting clinical studies
• A solid understanding of current GLP, GCP or GCLP standards
• Working knowledge of CAP/CLIA, CLSI and ISO 13485
• Experience hosting and participating in regulatory audits
• Excellent communication, interpersonal, organizational and multi-tasking skills
• Must be proficient with Microsoft Word, Excel, and PowerPoint
• Ability to interact and function in a highly productive work environment
• Ability to work independently and have good attention to detail
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• Direct experience working at a CRO, Biotechnology or Pharmaceutical company.
• Expertise across multiple technology platforms, including ECL, ligand-binding assays (LBA). Cell-based plate assays, flow cytometry and enzymatic activity assays,