Biorepository Manager

‍Job Overview:

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The Contract Storage Bio Repository Manager will oversee the day-to-day operations, client relations, and regulatory compliance of a contract storage biorepository, which provides biological specimen and process sample storage services to external clients, including academic institutions, biotech companies, pharmaceutical firms, and clinical researchers. This role ensures that all specimens are handled, processed, stored, and distributed according to client agreements and regulatory requirements. The manager will also be responsible for developing efficient workflows, maintaining high-quality standards, and fostering strong partnerships with clients to meet their biostorage needs.

Location: New Providence, NJ

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Key Responsibilities

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Client and Project Management:
♦ Serve as the primary point of contact for clients, managing client expectations, addressing inquiries, and ensuring contract specifications are met.
♦ Collaborate with clients to establish and document protocols for specimen and sample handling, storage, and retrieval.
♦ Oversee the intake and distribution of specimens  and samples based on client requirements and timelines.
♦ Prepare and provide regular reports to clients on specimen and sample  inventory, quality metrics, and storage conditions.
♦ Ensure clear communication between clients and internal teams regarding specimen status, storage needs, and regulatory compliance.
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Operations Management:
♦ Manage the day-to-day operations of the biorepository, including specimen and sample receipt, processing, cataloging, storage, and retrieval.
♦ Ensure biorepository operations adhere to applicable regulations, industry standards, and client contracts (e.g., FDA, GLP, GMP, HIPAA, etc.).
♦ Maintain and monitor all equipment (e.g., freezers, refrigerators, environmental systems, ect.) to ensure proper storage conditions, conducting regular checks and troubleshooting as necessary.
♦ Implement and update SOPs, quality assurance/quality control (QA/QC) programs, and biosafety protocols to maintain high-quality standards.
♦ Optimize workflows for efficiency and accuracy, ensuring timely specimen and sample retrieval and distribution.

Inventory and Data Management:
♦ Oversee the management of the biorepository’s inventory system, ensuring accurate tracking of specimens, samples, client data, and metadata.
♦ Ensure compliance with data privacy and security protocols (e.g., GDPR, HIPAA) for client and specimen data.

Regulatory Compliance and Quality Control:
♦ Ensure the biorepository complies with all relevant regulatory standards, including FDA, GLP, GMP, and GCP guidelines.
♦ Manage internal and external audits, including client audits and regulatory inspections, ensuring accurate documentation and compliance with all standards.
♦ Maintain records of all biosafety and biosecurity measures, including hazardous material handling and disposal where applicable.

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Leadership and Staff Management:
♦ Supervise and provide training to biorepository staff, ensuring adherence to SOPs, client specifications, and safety protocols.
♦ Manage staffing levels and shift schedules to meet client projectneeds and maintain operational efficiency.
♦ Provide ongoing training and development opportunities for staff to keep up with evolving biobanking technologies and regulatory updates.

Business Development Support:
♦ Support the business development team by assisting with client proposals, contract negotiations, and capacity planning.
♦ Assist with drafting and reviewing storage agreements, providing operational insights to ensure the feasibility of serviceofferings.
♦ Contribute to marketing and outreach efforts by highlighting thebiorepository’s capabilities, performance metrics, and customer service excellence.

Qualifications:
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Experience:

♦ Minimum of 3-5 years of experience in biorepository or laboratory management, with a focus on contract storage or client-facing services.
♦ Proven experience in handling biological specimens and managing large inventories in a regulated environment.

♦ Previous experience in client management, with a demonstrated ability to deliver high-quality service.

Skills:
♦ Strong knowledge of regulatory requirements (e.g., FDA, GLP, GMP, HIPAA) and industry best practices for biostorage.
♦ Excellent organizational skills with attention to detail and a commitment to maintaining accurate records.
♦ Strong leadership and team management abilities.
♦ Ability to communicate effectively with clients, regulatory bodies, and internal teams.
♦ Strong problem-solving and project management skills, with the ability to balance multiple client projects simultaneously.
♦ Ability to work independently with minimal oversight♦ Preferred Qualifications:

♦ Experience in managing biorepository services for pharmaceutical or biotech clients.
♦ Experience with international regulations and compliance (e.g., GDPR, ISO standards).

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Disclaimer: Tobin Scientific is an Equal Opportunity Employer practicing non-discriminatory recruitment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This job description provides an overview of the responsibilities and duties expected for this position. It's not exhaustive, and personnel may be asked to perform duties outside their typical responsibilities.