Job DescriptionPosition Summary:Within the BioServices business unit of Thermo Fisher Scientific. The NCI Clinical Repository (NCI-CR) is a cGMP drug storage facility or the housing and distribution of finished pharmaceutical clinical agents/drugs distributed by our sole client the National Cancer Institute(NCI). The Clinical Repository receives, stores, ships, and destruction of investigational cancer therapeutic agents provided by NCI. The site adheres to cGMP guidelines, stores in compliance with USP guidelines, ships following all applicable IATA guidelines, and packages destructions following DOT guidelines.The Asst. Project Director acts as a backup in the absence of the Project Director in being responsible for the Clinical Repository. This position will run drug department activities, and open label sections of the NCI-CR government contract repository operations.Duties and Responsibilities:
Leads all aspects of all open label drug processes including Receipts, Shipping, Returns and Destruction
Receives daily download clinical drug orders, fills out pertinent information, pulls orders, check and process orders for shipment.
Assists and guides Operations Manager, warehouse supervisor and receipt technicians with receiving and inspecting drug shipments.
Respond to client’s inquiries regarding the open label repository processes, shipping concerns, returns, and regulatory issues, and non- compliant events
Provides information for open label lean board and record open label shipments daily and metric updates to client, management and staff members as needed
Provides international trade regulation compliance information to client and the staff
Implement most efficient means to package non-traditional and non-Canadian international clinical drug shipment orders.
Ensures timely completion of all contract results including: Monthly Progress Reports, Monthly and Semi-Annual Inventory, User Cost Pricing, Updating Government Property List, Obtaining Quotes, Temperature Monitoring Report, Destruction Reports and other client requests.
Assist with acquiring Contracting Officer Authorization (COA) and associated tasks
Leads and addresses all Facility maintenance plans and coordinates repairs and improvements. Addresses and responds to all the emergency facility inquiries
Responsible for maintaining site compliance with cGMP
Primary point of contact for DG shipment inquiries, staff training and adherence to all the associated regulations.
Coordinates and completes tasks in the Quality Management Systems (Trackwise, Documentum, Maximo) and for audit preparation when vital
Responsible for performing gap analysis of the site processes and safety
Running site’s task open label leads/managers
Leads all aspects of site PPI program including GEMBA walks, JDI and Kaizens.
Responsible for content creation, revision and training of SOPs, SWIs and CWIs and controlled forms.
Works with Operations Manager and Project Director to resolve any inventory issues.
Liaison between Thermo Fisher resources, the Clinical Repository Staff and the Client
Assisting the Project Director with all contract related matters including budgeting, audit, client inquiries, SOW, and proposal writing
Additional duties may be assigned due to business and contract needs.
Location:4650 New Design Rd.Frederick, MD 21703Basic Minimum Qualifications:The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job optimally, an individual would complete the following duties listed below.
Can provide phenomenal people leader skills to reporting employees.
Requires excellent verbal and written communication skills.
Requires working proficiency in Microsoft Office
Requires excellent organization skills, tackle problems, attention to details, and being able to multitask.
IATA/DOT Proficient
Experience in a cGMP environment
Education/ Experience:
Requires a bachelor’s degree. Preferably a degree in pharmaceuticals.
5+ years repository operations experience or experience in the pharmaceutical or health care related field preferred.
Requires 2+ years management experience in healthcare related field.
Requires extensive experience with drug storage, distribution inventory management, and purchasing.
Certificates and/ or Licenses:Dangerous goods and IATA.Supervisory Responsibility:Management responsibility of all NCI CR open label operations staff.Work Schedule:8:00AM to 5:00 PM core hours (on-site) 40 hours/week, additional hours as the need arisesParticipate in the On-Call schedule as neededAttend to site emergencies after hours and on weekendsWork Conditions/Physical Requirements:
Comfortable working in a cold environment with exposure to dry ice, hazardous and infectious agents, marked changes in temperature.
Must use personal protective equipment and follow thru to safety protocols,
Have the ability to lift and carry up to 50 lbs,
Walk-in freezers or refrigerators periodically, process and handle materials frozen on dry ice (-78°C)
Use a computer up to 6 hours per day.
Work in a warehouse/repository environment.
Operate a forklift.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action EmployerThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.