Manager, BioPharma Biospecimen Management

4 weeks ago

Redwood City, United States Guardant Health Full time
Job Description

About the Role:

The Manager of Biospecimen Management is responsible for the supervision of Biospecimen Management Associates, Lead(s) and Supervisor(s). The Manager may supervise the daily operation of the Laboratory. The Manager monitors quality control and quality assurance, writes and reviews standard operating procedures, addresses issues, and takes remedial action when needed. The Manager ensures laboratory staff is correctly trained on all processes. The Manager demonstrates good judgment, sound analysis and decision-making, the ability to remain professional and composed under pressure, and the ability to communicate effectively across levels and functions. The Manager will ensure that the Biospecimen Management Lab team adheres to CLIA and CAP standards. The Manager complies with all applicable local, state, and federal laboratory requirements and operates under the direction of the Laboratory Director and Director of Biospecimen Management.

Essential Duties and Responsibilities:

  • Oversees BioPharma and Investigational Sponsored Trial sample processing for BSM
  • Collaborates with Sustain and Support, Clinical Operations, and Clinical Trials Operations to meet retrospective batch processing schedule, resolve project issues, and meet turnaround times
  • Coordinates remnant sample and cold storage chamber management with Pharma partners, Biorepository team, and Facilities
  • Collaborates with Technology Development to accommodate requests for non-standard workflows
  • Identify systemic issues and drive efficiency improvements for pharma workflows
  • Collaborate with Facilities department to manage San Diego shipments
  • Works with Clinical Study Coordinators to process all trials-related documents and assist in preparation for monitoring visits and audits
  • Engages with Quality to ensure timely initiation and resolution of DARs, NCRs, CAPAs, and complaints
  • Supports pharma partner audits and inspections
  • Provides supervision of the Biospecimen Management Supervisor(s) and Lead(s), may supervise other Biospecimen Management personnel and also daily procedures
  • Writes and reviews standard operating procedures, performs other administrative duties, including but not limited to: writing and reviewing employee performance evaluations, protocols, clinical trial sample tracking and equipment maintenance forms
  • Works closely with the Clinical Operations Supervisors and Client Services Department in developing efficiencies/processes between the functional areas to ensure that SOPs and best practices for each department are met
  • Reviews and documents routine preventive maintenance
  • Oversees training and competency of new and existing laboratory personnel
  • Represents the Biospecimen Management Department in cross-functional meetings
  • Manages and leads department projects and goals
  • Supports the Biospecimen Management team and is responsible for the daily operations of the laboratory including but not limited to scheduling, independently troubleshooting and resolving problems; and
  • Reports all quality and/or safety concerns to the Laboratory Director or Safety Officer.

Qualifications
  • Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science, or related field;
  • A minimum of 4 years of Clinical Laboratory experience or equivalent high complexity and volume laboratory experience preferred;
  • Minimum 3 years of lab experience working with clinical trial samples
  • A minimum of 2 years of supervisory experience with a team that processes biopharma study and clinical trial samples is preferred, or 1 year of supervisory experience at Guardant Health
  • Experience creating and revising a standardized lab schedule to meet changing business needs;
  • Working knowledge of local, state, and federal laboratory regulations;
  • Able to integrate and apply feedback in a professional manner;
  • Ability to analyze and problproblem-solvec issues that impact lab operation;
  • Ability to work as part of a team;
  • Strong problem-solving abilities
  • Adept at dealing with varying sample volumes and changing priorities.
  • Strong computer skills;
  • Outstanding professionalism and leadership skills;
  • Strong, proactive communicator with ability to maintain open communication with internal employees, managers and customers as needed;
  • Ability to provide direct supervision to laboratory personnel;
  • Strong project management abilities.

Work Environment:

  • Hours and days may vary depending on operational needs;
  • Standing or sitting for long periods of time may be necessary;
  • May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high-speed centrifugation;
  • May be required to lift routine office supplies and use office equipment;
  • Majority of the work is performed in a desk/office environment;
  • Ability to sit for extended periods of time.

Additional Information

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $123,900 to $167,300. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

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