Project Director (Gov Contracts)

Thermo Fisher Scientific • Full-time • Germantown, MD, US • $130,000 - $194,900 / year • 4d ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Based in Germantown, MD. This position is within the Fisher BioServices business unit of Thermo Fisher Scientific.

Discover Impactful Work:

The Project Director is responsible for the overall operational management of the DMID-CMS government contract, budget management, lab services, bio-repository, and pharmaceutical management. This position requires making decisions vital to lead and conducting repository operations, including receipts, storage, inventory, labeling, encapsulation, and distribution of pharmaceuticals, clinical products, and biologics. This position plans, coordinates, and implements operation policies and procedures that ensure compliance with cGMP and CAP regulations. They craft, coordinate, and implement special projects at the request of the DMID Project Officer.

Work Schedule:

8:00 AM to 5:00 PM hours, additional hours as required.

A Day in the Life:

Responsible as the primary contact for and collaboration with the Project Officer and DMID personnel, clinical site principal investigators, prime vendors, and manufacturers and for fulfilling all contractual requirements.
Responsible for all DMID-CMS operations, including coordinating clinical agents' requests, shipments, maintenance of all required records, emergency backup procedures, facility & equipment operation, and validation, as well as all day-to-day operations.
Lead effort ensuring all SOPs are accurate and current, verification of clinical agent and supply inventory, processing of emergency shipments, supervision and training of DMID-CMS staff.
Lead effort to maintain reference documents related to DMID protocols and production quality documents.
Responsible for crafting and maintaining quality documents in compliance with FDA regulations and company policies.
When required, purchase commercially available drugs from FDA-approved sources.
Maintain the distribution licenses and correspondence with the states' Boards of Pharmacy.
Develops and leads contract operational budget, monitors and reviews monthly vouchers, reports, and forecasts changes.
Ensure timely preparation of monthly progress reports, end-of-option period reports, and physical inventory reports.
Practice and promote equal employment opportunity
Must demonstrate and promote our core values, build an environment of respect and inclusion, serve as a Role Model Leader to employees
Develop and maintain a presentation of the site-specific occupational safety and health training following federal, state, and local regulations.

Keys to Success:

Education

Bachelor of Science degree in Pharmacy required. Advanced degree in Pharmacy preferred.

Experience

3-5 years of management experience, preferably Pharmacist staff.
3 years of project management experience required.

Certificates and/ or Licenses:

Registered pharmacist in the state of MD required.
TSA certified highly desireable.

Knowledge, Skills, Abilities

Demonstrate knowledge of state and federal laws and regulations governing pharmacy services, understanding of import/export regulations, knowledge of procedures for handling and shipping biohazardous agents & dangerous goods, and IATA regulations.
Excellent analytical, problem-solving, research, written, editing, interpersonal, and verbal communication; proficiency in computer skills and in using Internet tools to acquire technical reports from Government and other Web sites.
Strong interpersonal project management skills and ability to work with multiple projects. Management experience of personnel and facilities.
Strong Leadership, organization development, and people management skills
Knowledge and experience with current Good Manufacturing Practices (cGMP) and CAP accreditation requirements.
Demonstrated understanding of financial management.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Compensation And Benefits

The salary range estimated for this position based in Maryland is $130,000.00–$194,900.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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