Thermo Fisher Scientific Assistant Project Director in Germantown, Maryland
Position Summary: Responsible for the successful management and coordination of assigned contracts involving biological repository management and kit production, in coordination with the Project Director. This includes maintaining sufficient staffing levels; ensuring all procedures are in accordance with contract scope of work, and in compliance with company policies and Federal, State, and local regulations, and that all employees are properly/regularly trained; developing annual budgets and tracking contract costs; maintaining strong, open relationships with client representatives; hosting and coordinating client and agency site inspections and internal audits; and demonstrate and promote company initiatives.
Assist the Project Director in meeting departmental goals supporting company goal tree.
Ensure all contractual goals are met on time and within budget.
Monitor and evaluate operations utilizing key metrics and report to Project Director on a regular basis with recommendations for continuous improvement.
Provide internal sales/contract support during contract development and/or revision. Review proposals for contracts and amendments prior to submission.
Oversee and coordinate daily workflow to meet project milestones.
Provide scheduled and unscheduled periodic reports for clients and Project Director.
Ensure all databases (i.e. TrackWise, iComply, CoreLIMS, etc.) are current and accurate.
Perform and/or ensure that periodic assessments of current SOPs are performed, revised where necessary, and initiate new written procedures where appropriate.
Plan and oversee that necessary repository equipment is acquired timely and applicable major/minor equipment and facility maintenance are performed.
Apply cGMP standards in all areas of responsibility. Perform or assist in performing monthly voucher reviews for accuracy and consistency with contract SOW. Ensure all facilities are maintained and all deficiencies are corrected in a reasonable time. Ensure employee and facility safety and security. Participate in and lead staff hiring functions. Perform annual and biannual PMDs. Develop, in coordination with appropriate staff, cross-training plans for the team to ensure employee growth and resource back up availability. Promote welfare and morale of staff. Promote additional company services for business expansion.
Minimum Requirements/Qualifications: Must have excellent organizational and project management skills. Knowledge of 21 CFR is required, and familiarity with 29, 42 and 49 CFRs is strongly preferred. Must be able to execute a project from start to finish. Must be resourceful and able to work independently. Must possess clear and effective oral and written communication skills, and be able to manage various internal and external issues independently and successfully. Must be client focused. Must possess a basic understanding of management accounting.
Education/Training : Bachelor’s Degree required, advanced degree preferred (MS degree in life science, M.B.A.). Five years experience working in a biological repository setting; two years experience in project management. IATA Dangerous Goods Certification. Project Management Certification preferred.
Business Experience : Five years experience in biological repository and/or inventory/logistics/supply chain management. Experience in supervising/managing staff.
Knowledge/Skills : Ability to read and interpret CFRs, NIH publications, and other government agency regulations as they pertain to various projects; Project management.
Working Conditions: Must be able to work at a desk for 8hrs, capable of lifting 50lbs and withstanding subzero temperatures for prolonged periods of time. Must be comfortable working in a biohazardous environment, and able to receive certain immunizations, if necessary.
Non-Negotiable Hiring Criteria: Knowledge of 21 CFR
Ability to multitask and manage multiple projects that vary substantially in content
Concise oral and written communication skills
Experience with client relationship management
Thermo 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.