Supervisor, Sample Management

Supervisor, Sample Management

Durham, NC

Sample Management /

FT /

On-site

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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.

Essential Responsibilities

• 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

Additional Responsibilities

• Other duties as needed

Minimum Preferred Qualifications: Education/Experience

• 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.

Minimum Preferred Qualifications: Skills

• 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

Preferred Experience

• 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

Supervisory Responsibility

• Sample Management Technicians
• Sample Management Specialists
• May supervise Data Management Specialists

Supervision Received

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

Working Environment

• 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)

Physical Demands

• 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

Position Type and Expected Hours of Work

• 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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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