Manager, Specialty Production

BioIVT•Durham, NC

7d•Onsite

About The Position

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.

Requirements

PhD in life sciences or related field with a minimum of five years’ experience in cell culture.
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.
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.

Nice To Haves

MS in life sciences with a minimum of 10 years’ experience preferred.
ISO, GMP, or GLP experience preferred.

Responsibilities

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.
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.
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.