Bioagilytix15d ago

New

Supervisor, Sample Management

United States·DurhamFTmid

OperationsManagement

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Quick Summary

Overview

At BioAgilytix, we are passionate about premier science and the impact it has on our world.

Technical Tools

OperationsManagement

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

The Supervisor, Sample Management, is responsible for supervising a team of Technicians and Specialists to ensure timely and accurate GxP/CDX-compliant processing of incoming and outgoing samples and reference materials. It is a 'working' supervisor role requiring time split preferentially towards in lab, but office duties as well.

This role requires a shift schedule of Monday-Friday, 1:00pm-9:00pm EDT.

Supervises a team of Technicians and Specialists, including but not limited to ensuring all team members are trained and able to successfully complete all responsibilities; responsible for overseeing on-time availability of samples and regulatory (GxP, CDX-CAP/CLIA) compliant processing of samples; and scheduling the work of team members under the oversight of senior management

Supervises the professional development of direct reports

Conducts performance reviews

Coaches toward professional success

Coordinates with study personnel (e.g., project Supervisor, project managers, coordinators) to prioritize departmental tasks for on time delivery

Resolves incidents, initiating deviations, and CAPA's, when appropriate, under the supervision of the Manager, Sample Management

Enacts process improvements

Ensures data integrity and traceability

Writes/reviews Sample Management SOPs and other associated SOPs as required

Participates in training technician and specialists when appropriate

Participates in external audits/inspections; may lead tours of sample management area

Generates and maintains records in a regulatory compliant manner

Contributes to oversight of Sample Management laboratory, including storage units and other equipment, under supervision of senior management

Executes Technician and Specialist responsibilities including but not limited to:

Receives shipments into Sample Management

Initiates sample chain-of-custody

Provides sample receipt notification

Ships samples to domestic and international destinations

Manages final disposition of study samples

Accessions samples into LIMS and/or LIS

Manages pre-and post-test sample storage

Pulls and checks out samples for testing; checks in samples after testing

Execute internal post task execution audits to ensure completion according to standards and SOPs

Follows BAL SOPs

Other duties as needed

High School diploma and not less than six (6) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environment

Previous people leadership experience, including supervising, coaching, mentoring, or developing team members, is preferred.

In-depth knowledge of GxP and/or CDX regulations, specifically as they relate to Sample Management

Ability to lead a team in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner

Ability to take direction well and multi-task

Acute attention to detail and excellent organizational skills

Excellent oral and written communication skills

Proficiency in MS Excel and Word

Proficiency in LIMS and Quality Management software packages

Associate degree in biological science or related field and not less than four (4) years’ experience in sample management or related field in a biotech or pharmaceutical GxP-regulated environment

Bachelor’s degree in biological science or related field and not less than three (3) years’ experience in sample management or related field in a biotech or pharmaceutical GxP-regulated environment

Sample Management Technicians

Sample Management Specialists

May supervise Data Management Specialists

Infrequent supervision and instructions

Frequently exercises discretionary authority

Lab and office environment

Use of personal protective equipment such as safety glasses, lab coats, and gloves

Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

Potential exposure to biological fluids with possible exposure to infectious organisms (lab)

Potential exposure to skin and lung irritants, toxic materials, and hazardous waste (lab)

Exposure to fluctuating temperatures on rare occasions (lab, loading dock)

Ability to work in an upright and/or stationary position for up to 8 hours per day

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment

Frequent mobility needed

Occasional crouching or stooping, with frequent bending and twisting of upper body and neck

Light to moderate lifting and carrying (or otherwise moving) objects, including laboratory samples, laboratory equipment, and laptop computer, with a maximum lift of 30 pounds

Ability to use personal protective equipment and work effectively in freezers as cold as -80°C

Ability to access and use a variety of computer software

Ability to communicate information and ideas so others will understand, with the ability to understand information and ideas presented through spoken words and sentences

Frequently interacts with others to obtain or relate information to diverse groups

Requires multiple periods of intense concentration

Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence

Ability to perform under stress and multi-task

Regular and consistent attendance

This is a full-time position with a shift schedule of Monday-Friday, 1:00pm-9:00pm

Some weekend, holiday, and evening work required

BENEFITS AND OTHER PERKS

Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program

COMMITMENT TO EQUAL OPPORTUNITY

BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

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