Manager, BioPharma Biospecimen Management

Found in: Resume Library US A2 - 2 weeks ago


Redwood City California, 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.


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