Manager, Specialty Production
Durham, NC, USA
BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens, including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research, aiming to improve patient outcomes by coupling comprehensive clinical data with donor samples. As the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science.
SUMMARY
The Manager, Specialty Production serves as part of the ADME-Tox NC Site Leadership team responsible for providing supervision and technical direction for all specialty Production including product development and production, customer support, and ancillary scientific services. They are also expected to provide strong, hands-on scientific leadership, independently conduct laboratory experiments, critically analyze data and determine the next steps to be taken.
Success in this role will be determined by the ability to develop and lead an entrepreneurial, scientifically oriented team through exemplary servant leadership.
This position will ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, general State and Country Regulations such as but not limited to (CLIA, CAP, USP, ISO 9001, USDA regulations, HTA license, DEA and State Controlled Substance programs) where site appropriate.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
Specialty Production
- Oversee, manage and keep direct hands-on involvement in the laboratory aspects and related specialty production and specifically blood and exosome products.
- Support development and utilization of automated product platforms and quality assessment tools in specialty production processes.
- Provide technical support for production.
- Establish and report on metrics that support the Division and the Company goals.
General Management:
- Work directly with management to carry out business objectives and develop new research systems based on commercial need.
- Maintain effective communication, coordination, and working relations with other personnel and management. Keep management informed of area activities and significant concerns.
- Conceive of and develop new research areas/products/contract services.
- Additional responsibilities will include occasionally working with our procurement partners as well as working with the business development team in presentations to pharmaceutical companies.
- Supervises employees in accordance with the organization’s policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; supporting managers/directors in performance appraisals; reviewing weekly timesheets and time-off requests; providing regular feedback, and setting individual goals aligned with team and department goals.
- Responsible for effective and efficient team production, ensuring adherence to company quality, production, and timeline standards, reallocating resources, and implementing contingency plans when production targets and timelines are threatened. Holds responsibility for schedule and resource planning to achieve team quality standards and production goals.
- Communicate to each employee his/her job responsibilities and expectations for his/her position.
- Monitor the performance of staff regarding their progress toward mutually agreed upon career goals on an ongoing basis and make appropriate communications regarding performance to employee, management, and human resources.
- Ensure laboratory staff complete all required safety training before conducting work. Monitor and manage annual re-training as necessary.
This job description is not intended to be all-inclusive. Employees may perform other related duties as required to meet our on-going needs.
TRAVEL
This position may require up to 15% travel over the course of a year.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education and/or Experience
- PhD in life sciences or related field with a minimum of five years’ experience in cell culture. MS in life sciences with a minimum of 10 years’ experience preferred.
- ISO, GMP, or GLP experience preferred.
Other Skills and Abilities
- Working knowledge of biochemistry/chemistry/Cell Culture.
- Proven ability to independently conceive, initiate and develop research programs in line with business objectives.
- Exceptional organizational skills.
- Demonstrated published research.
- Proven track record of leading cross functionally.
- ISO, GMP, or GLP experience preferred.
- Ability to analyze processes for compliance, determine, and communicate vulnerabilities.
- Demonstrated ability to readily adapt to changing priorities, effectively manage own time, and set priorities for direct reports to ensure tasks and multiple projects are prioritized and completed on time.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to: stand; walk, sit, stoop, kneel, crouch, crawl, speak, hear/listen, smell, display manual dexterity, reach with hand and arms. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
A full-time within Monday-Friday work week during general business hours. While performing the on-site duties of this job, frequently required to use personal protective equipment to prevent exposure to hazardous materials. The employee has potential for exposure to fumes, airborne particles and toxic or caustic chemicals, biohazards, flammable liquids, and risk of radiation. The employee is occasionally required to use equipment with moving mechanical parts, with risk of electrical shock and vibration. The noise level in the work environment is usually moderate, at times, the noise level can be louder and hearing protection may be required. The employee may work both inside and outside in heat/cold, wet/humid, and dry/arid conditions.
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. All job requirements are subject to modification to reasonably accommodate individuals with disabilities. Continued employment remains on an at-will basis, unless otherwise contractually bound