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Director Biorepository Operation Jobs (NOW HIRING)

Pfizer

$177 - $294/hr

... biorepository and then distributed to our network of internal and external testing laboratories ... Modernize operations through digital and automation innovation. Lead automation, robotics ...

Vanderbilt Health

Manager, Laboratory

Nashville, TN

Direct day-to-day biorepository and laboratory operations supporting academic and commercial investigators. * Optimize workflows related to tissue procurement, processing, annotation, storage, and ...

IBX

Cell Services Supervisor - Second Shift

Piscataway, NJ

$15 - $19/hr

Company Description As the world's largest university-based biorepository, Infinity BiologiX has ... Director and Manager of the Cell Lab on all operational aspects of management of the lab. This ...

Ohio State University

This position blends research operations, compliance, biorepository management, and stakeholder ... the IMDP Director with budgeting, financial tracking, annual reports, and grant proposal ...

IBX

Cell Services Supervisor - Second Shift

Piscataway, NJ · On-site

$15 - $19/hr

Company Description As the world's largest university-based biorepository, Infinity BiologiX has ... to the Director and Manager of the Cell Lab on all operational aspects of management of the lab ...

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Director Biorepository Operation information

What does a director of biorepository operation do?

A Director of Biorepository Operations is responsible for overseeing the management, storage, and distribution of biological samples in a laboratory or clinical research setting. They develop and implement standard operating procedures to ensure sample integrity, regulatory compliance, and quality control. Additionally, they manage staff, budgets, and collaborate with researchers to support scientific studies. Their leadership ensures that biorepository operations run smoothly and support the organization's research goals.

What are the key skills and qualifications needed to thrive as a director of biorepository operation?

To thrive as a Director of Biorepository Operations, you need expertise in biospecimen management, regulatory compliance, and laboratory operations, usually backed by an advanced degree in life sciences or a related field. Familiarity with laboratory information management systems (LIMS), quality management systems, and certifications such as CAP or ISO 20387 are highly valued. Excellent leadership, organizational, and communication skills are crucial for overseeing teams and collaborating with stakeholders. These skills ensure the secure, efficient, and compliant handling of biological samples vital for research and clinical advancement.

What are some of the main challenges faced by a director of biorepository operation, and how can they be addressed?

A Director of Biorepository Operations often faces challenges such as ensuring sample integrity, maintaining regulatory compliance, and managing large, diverse teams. Balancing the demands of long-term sample storage with rapid retrieval for research or clinical use requires robust processes and continual staff training. Collaboration with researchers, IT, and quality assurance teams is crucial to streamline workflows and address technical or logistical issues promptly. Staying current on evolving regulations and investing in state-of-the-art inventory systems can help mitigate risks and improve operational efficiency.

What are popular job titles related to Director Biorepository Operation jobs?

For Director Biorepository Operation jobs, the most frequently searched job titles are:

Infographic showing various Director Biorepository Operation job openings in the United States as of September 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Executive Director/Site Head

Frederick, MD • On-site

Precision for Medicine
Biotechnology Research and Development • 501 - 1,000 employees
Learn more about Precision for Medicineexternal

Full-time

Medical, Life, Retirement, PTO

Re-posted 10 days ago

Job description

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,

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. 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.
Reasonable estimate of the current range
$203,200- $304,800 USD
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.

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