Global Director, Sample Management

BioAgilytix is a leading contract research organization CRO that specializes in large molecule bioanalysis. Our fully integrated laboratory services support every stage of biologics development, from early discovery through pre-clinical studies and clinical phases, in a fully regulated environment. The best science demands the best people, and our global team of professionals in Durham, North Carolina; Boston, Massachusetts; and Hamburg, Germany bring a passion for helping pharma and biotech companies achieve more for the patients they serve.

The Global Director, Sample Management, will lead global teams in sample receiving, accessioning, and processing. He or she will drive global harmonization and process improvements, validation, and transfer of new processes and systems into the sample management laboratory. The position will be responsible for equipping, staffing, and overseeing systems for receiving and processing laboratory samples according to established procedures. He or she will serve as the primary leader for all investigations and non-conformances associated with sample processing as well as oversee cross-functional projects implementing best practices to ensure the area meets business needs. The Director will develop processes to support clear communication to all levels within the laboratory and inspire the Sample Management team by setting direction and creating a work environment that encourages goal realization and employee growth.

Essential Responsibilities

• Collaborate with all laboratory teams in developing, transferring, scaling and validating sample pre-analytic processes, including sample acceptability, accessioning, and sample preparation in accordance with GMP, GLP, GCP, CLIA, and quality guidelines.Provide leadership to the team by promoting communication and collaboration, proactively supporting employee development initiatives, and promoting cross-functional collaboration and teamwork.
• Provides visibility and supporting information to assist leadership in prioritization of projects based on changing functional needs, resource capacity constraints, risk exposure, and ensuring clarity in project interdependencies.
• Oversee people leaders as well as individual contributors defining clear roles, responsibilities and expectations for department staff.
• Drive teams through root cause analysis/nonconforming event analysis associated with sample management using quality system tools 5 Whys, FMEA, fishbone diagrams, etc..
• Develop and oversee training for all employees within the sample management department in collaboration with training teams.
• Mentors next level supervisors, managers, and leaders within the department to continue to grow talent within the laboratory.
• Supervise staff including but not limited to organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
• Other duties as needed

Minimum Acceptable Qualifications

Education:

• Bachelor’s degree in biological science or related field

Experience:

• Not less than ten 10 years’ experience in a clinical laboratory or high-volume laboratory environment
• Not less than five 5 years’ experience managing in a CLIA environment
• Not less than five 5 years’ experience with molecular biology techniques
• Extensive knowledge of GxP regulations

Skills:

• Excellent leadership skills to be a primary leader for a diverse team with specialized expertise
• Takes initiative to improve systems, processes, procedures to drive quality into daily production
• Must possess strong coaching/counselling skills to support performance management
• Proven ability to work effectively cross-functionally in project team situations, influence, and collaborate with stakeholders, as well as work independently leading teams forward with a clear vision
• Proficient in the use of all Microsoft applications i.e., Word, Excel, PowerPoint and Outlook
• Demonstrated proficiency in the use of LIMS and Quality Management software packages

Preferred Credentials

• Master’s degree in biological science or related field
• Not less than six 6 years’ experience working in a biotech, pharmaceutical, CRO/CMO or similar organization

Working Environment

• Primarily office
• Occasional laboratory/clinical environment
• Exposure to biological fluids with potential exposure to infectious organisms
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
• Rare exposure to skin and lung irritants, toxic materials, and hazardous waste
• Personal protective equipment required, such as protective eyewear, garments, and gloves
• Exposure to fluctuating and/or extreme temperatures on rare occasions

Physical Demands

• Ability to work in an upright and/or stationary position for up to eight 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 office and lab equipment
• Frequent mobility needed
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying or otherwise moving objects, including laptop computer and supplies, with a maximum lift of 20 pounds
• Ability to access and use a variety of computer software
• Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; 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
• Occasional weekend, holiday, and evening work required

Disclaimer

The tasks, duties, and responsibilities listed in this job description are not exhaustive. BioAgilytix, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities to employees. Equivalent experience, skills, and/or education may be substituted for certain requirements, so qualifications of incumbents may differ from those listed in the job description. The Company, at its sole discretion, will determine what is considered equivalent to the qualifications described above. Further, this job description does not constitute a contract of employment, either expressly or by implication.

Comments

BioAgilytix requires that all employees be legally authorized to work in the United States. In the event an applicant does not have current work authorization, BioAgilytix will determine, in its sole discretion, whether to sponsor an individual for work authorization. However, based on USCIS requirements, not all roles are suitable for sponsorship.

Equal Opportunity Employer

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.