Executive Director/Site Head
Summary
Oversee laboratory operations for a precision medicine company in Frederick, MD, ensuring regulatory compliance, assay development, and team leadership across bioanalysis, flow cytometry, and companion diagnostics.
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:
- PhD in Immunology or related field
- 20+ years’ relevant experience
- 15+ 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,
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
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Candidates must be legally authorized to work in the country of employment without employer sponsorship.
Skills
As published by greenhouse · 16 questions
Basics
First Name, Last Name, Email, Phone, Resume/CV, Cover Letter, Location
Short answers (8)
- LinkedIn Profile optional
- What is your desired salary?
- If yes, when and which company? optional
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- Legal Address - City
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Pick from a list (8)
- Are you authorized to work lawfully in the country/location for which you are applying?
- Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status.
- Have you ever worked for Precision Medicine Group or one of its affiliated companies?
- Have you ever interviewed with Precision Medicine Group or an affiliated company?
- Are you currently subject to a Non-Compete or Non-Solicit with your current employer?
- I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge. If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment. I authorize the Company or its agents to confirm all statements contained in this application and/or resumes as it relates to the position I am seeking and to the extent permitted by federal, state, or local law. I agree to complete any required authorization forms for the background investigation. I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by federal, state, and local law, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information. If hired I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the United States. I also understand that the Company employs only individuals who are legally eligible to work in the United States. This application will remain active for 60 days. Any applicant wishing to be considered for employment after that time must reapply. UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
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