Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The [Personalis NeXT Platform](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.personalis.com%2Fimmunoid- next-platform%2F&esheet=52534858&newsitemid=20211118006333&lan=en- US&anchor=Personalis+NeXT+Platform&index=2&md5=994af974cf5c973f890d0bc5a72ef63b)® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' [Clinical Laboratory](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.personalis.com%2Fabout%2Flaboratory%2F&esheet=52534858&newsitemid=20211118006333&lan=en- US&anchor=Clinical+Laboratory&index=3&md5=214191f02a8e211e8a6037256ce4a478) was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists- accredited.

Summary:

The Sr. Manager, Laboratory Operations Sample Management has demonstrated expertise with
biological samples handling and banking. Additionally, this individual has knowledge and expertise
regarding the procedural, quality and compliance aspects of samples collection, storage, shipment, and
destruction, needed to support Personalis’ operations needs. The Sr. Manager, Laboratory Operations
Sample Management has a track record of working in regulated environments (CLIA/CAP and/or FDA),
needed to support of Personalis sponsored clinical trials. The Sr. Manager, Laboratory Operations
Sample Management is a key partner for the Lab Operations sample processing teams, Project
Management, and R&D and Process Development departments. The Sr. Manager, Laboratory
Operations Sample Management will lead a team of BioBanking associates as well as head up the
Accessioning Team who is responsible for the daily intake of biological samples that we receive from our
customers and partners. The Sr. Manager, Laboratory Operations Sample Management is ultimately
responsible for all biological sample storage, return, and destruction logistics, both long and short term.

Responsibilities:

• Oversight of all aspects of biological sample receipt, storage, shipment, and destruction.
• Understand quality and compliance procedural aspects and work closely with the Quality Team & Regulatory Compliance team to draft, execute, and own SOPs related to samples collection and storage.
• Be a subject matter expert for all aspects related to biological samples storage.
• Develop and maintain the BioBank and Sample Management department budget.
• Analyze industry and scientific trends and implement solutions to drive scientific and technical innovation related to BioBanking and Sample Accessioning.
• Lead and manage a team of BioBanking associates and Sample Accessioning team staff.
• Hire, train, mentor, and coach employees in the BioBanking and Sample Management department.
• Lead the resolution of all escalated issue and queries relating to samples within our inventory.
• Lead the effort to research, purchase, install, calibrate, and maintain BioBanking storage equipment for Personalis BioBanking services.
• Work with Personalis automation experts to develop and implement automated storage solutions.
• Represent the BioBank and Sample Management Team for all Personalis audits, including customer audits and regulatory body audits.
• Support Personalis sponsored clinical trial efforts by following regulated procedures for the receipt, storage, and distribution of biological samples.

Requirements:

• Bachelor of Science or related degree preferred.
• 8+ years of experience in a related area with biological sample management.
• 2+ years of people management experience required.
• Experience working in CLIA /CAP, and/or GCLP and/or FDA regulated environments.
• Experience with LIMS systems.
• Knowledge of FDA GCP-related requirements for clinical trials.
• Experience with automated sample storage systems and setting up automated processes for BioBanking including selection of labware types to make storage efficient, LIMS integration, handoff to downstream processes, building redundancies, and emergency planning.

Required Skills :

• Excellent verbal and written communication skills.
• Strong attention to detail and accuracy of information.
• Understanding of laboratory sample handling and regulations.
• Interpersonal skills for managing and coaching staff and co-workers.
• Strong organizational skills, including time management, ability to meet deadlines, ensuring an orderly workplace, project management and priority setting.
• Conceptual skills to identify and resolve problems, identify and act upon opportunities, understand and use data/technology, multi-task, and negotiate with others.
• General software skills, including Microsoft products and an aptitude for learning other products of various types.
• Extra hours will be required from time to time to meet critical deadlines and department objectives.

_Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package. _

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