Supervisor, Sample Management

BioAgilytix • Durham, NC

9d • Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

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
• Other duties as needed

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED