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 equally between the lab and the office.
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 receiving and accessioning
- Resolves discrepancies, 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 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 ManagementInitiates sample chain-of-custodyProvides sample receipt notificationShips samples to domestic and international destinationsManages final disposition of study samplesAccessions samples into LIMS and/or LISManages pre-and post-test sample storagePulls and checks out samples for testing; checks in samples after testing- May process PBMCs
- Data QC/review
- Communicates with clients as needed
- Follows BAL SOPs
Additional Responsibilities
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
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 and/or Lab Assistants
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
- Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
- Some weekend, holiday, and evening work required