Supervisor, Sample Management
BioAgilytixDurham, NC
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Overview
Schedule
Alternate-schedule
Full-time
Career level
Senior-level
Remote
On-site
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Job Description
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.
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FAQs About Supervisor, Sample Management Jobs at BioAgilytix
What is the work location for this position at BioAgilytix?
This job at BioAgilytix is located in Durham, NC, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at BioAgilytix?
Employer has not shared pay details for this role.
What employment applies to this position at BioAgilytix?
BioAgilytix lists this position under the following employment categories:
- Alternate-schedule
- Full-time
What experience level is required for this role at BioAgilytix?
BioAgilytix is looking for a candidate with "Senior-level" experience level.
What benefits are offered by BioAgilytix for this role?
BioAgilytix offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Disability Insurance, Life Insurance, Family/Dependent Health, Paid Holidays, Paid Vacation, Parental and Family Leave, and 401k Matching/Retirement Savings for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at BioAgilytix?
You can apply for this role at BioAgilytix either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.