At Fisher BioServices, we specialize in the management of critical biological materials in support for the advancement of cell therapy, high value biologics, and population-based public health research. We provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the bedside. Fisher BioServices is a brand of Thermo Fisher Scientific, the world leader in serving science, and member of the BioPharma Services Division. To learn more please visit www.fisherbioservices.com.
· Responsible for repository daily operations, staff and facility management.
· Responds to all contract deliverables and statements of work.
· Prepares monthly, quarterly and annual reports according to contract requirements.
· Develop annual operating budget and capital budget for the repository and meets budgetary goals. Monitors and approves all repository expenses. Reviews and approves monthly vouchers to ensure accurate expense reporting to meet targets.
· Provides oversight to ensure all personnel issues are addressed including performance management and development of employees, writing job descriptions, establishing and enforcing employee work and leave schedules; interviewing prospective employees and providing recommendations to HR for hiring, firing and promotion of employees.
· Directly supervise and mentor Assist Project Director and Operations Manager.
· Review and approve all controlled documents supporting contract operations. Work with repository managers in the development and refinement of procedures. Ensure alignment of project Quality Plan with BioServices Quality System.
· Responsible for development and presentation of site specific occupational safety and health training in accordance with federal, state and local regulations and company policy.
· Ensure that all employees adhere to Corporate and BioServices policies and procedures.
· Responsible for primary interface with USG personnel, clinical site principal investigators, prime vendors, and manufacturers.
· Coordinate the destruction of expired or returned agents.
· Must demonstrate and promote our core values, communicate new policies and serve as a Role Model Leader to employees.
Position Summary: This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Project Director is responsible for overall operations for the DMID government contract as well as supervising the Lab and Operations Managers. In this position, decision making is necessary to manage and conduct repository operations including receipt, inventory, and distribution of clinical products and biologics in compliance with cGMP regulations. The Project Director will plan, coordinate, and puts into action all operation repository policies and procedures. The Project Director will design, coordinate, and implement special projects at the request of the DMID Project Officer.
Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.
- Requires excellent verbal and written communication skills.
- Requires knowledge of Inventory Management.
- Requires detailed knowledge of import/export regulations.
- Requires knowledge of state and federal laws and regulations governing pharmacy services.
- Requires skills in application of cGMP regulations.
- Requires knowledge of procedures for handling and shipping biohazardous agents
- Requires detail oriented, excellent computer and communication skills.
- Requires management experience of personnel and facilities.
- Requires experience safe handling of infectious materials.
- Requires knowledge biological and Chemical Safety procedures.
- Requires Hazardous Material Disposal training.
- Requires knowledge of Commercial Export Controls.
- Requires knowledge and experience with current Good Manufacturing Practices (cGMPs).
- Requires Bachelor’s degree.
- Requires Registered Pharmacist.
- Requires 5+ years pharmacy work experience.
- Requires 3+ years management experience.
Requires Dangerous Goods Transportation IATA certification. TSA certified.
Responsible for all DMID staff.
8:00AM to 4:30PM core hours, additional hours as required.
Work Conditions/Physical Requirements:
- Must be able to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
- Must use personal protective equipment and adhere to safety protocols.
- Must be able to lift and carry up to 50 lbs.
- Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-196°C).
- Must be able to work in walk-in freezers or refrigerators periodically.
- Must be able to use a computer up to 6 hours per day.
Must be able to work in a laboratory and warehouse/repository environment