Job Description

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 Clinical Trials Division. To learn more please visit www.fisherbioservices.com.
Position Summary: This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Project Support Associate provides administrative support to Project Managers for successful completion and supply maintenance over the life cycle of each project. Project support activities include task completion and issue resolution with internal customer procedures and support systems.
Duties and Responsibilities:

• Works with the Client and the internal project management team to finalize project specifications. This may include meetings either at Fisher BioServices or at the client's premises.
• Assists in setting up and maintaining study filing systems and maintains accurate records for all work undertaken.
• Joint responsibility with the Project Manager for ensuring that all Fisher BioServices activities come together in a timely manner to meet the customer and study requirements.
• Coordination and communication of all relevant activities, both internal and external to ensure that all services and products are ready for the start of the study or as required by the customer.
• Use of appropriate project planning tools to communicate milestones and critical path activities and responsibilities.
• Timely provision of reports and other information to customers if applicable.
• Works to optimize production schedules balancing the customer requirements with best use of available capacity.
• Creates and/ or supports creation of operational documentation using internal systems. Create bill of materials and coordinate creation and review of billing packages.
• Provides back-up support to the Project manager.
• Monitors project activities and day to day business and establishes a customer approved job specification.
• Collects all information on a study design including; correct label texts, coordination of secondary packaging materials and tools, coordination of label production, production/review of all batch documentation for operations, coordination of shipments through the logistics department, and preparing and reviewing GMP documents in a timely manner.
• Applies Good Manufacturing Principles in all areas of responsibility.

Education:

• Associate Degree from an accredited college or university required, preferably in a health-related field.

Required Experience:

• Requires 1-2 years of successful experience in project management or equivalent experience.

Preferred Qualifications:

• Prefer proficiency in appropriate project planning tools e.g. Microsoft Project to communicate milestones and critical path activities and responsibilities.
• Prefer in depth understanding of clinical trials.
• Prefer Certification in Project Management by a recognized institution in project
  management.

Duties & Responsibilities:
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

• Requires understanding and competent use of SOPs required by company Quality standards.
• Requires excellent communication and project coordination skills.
• Requires excellent organizational, planning, verbal, written and numerical skills with the ability to analyze and define solutions and manage multiple tasks to meet strict deadlines.
• Requires strong and effective communicator with the ability to effectively present information and respond to questions from groups of managers and clients.
• Requires ability to develop strong customer management and relationship building skills; proactively anticipates, understands, and responds to the needs of clients to meet or exceed their expectations.
• Requires ability to learn and master all internal systems associated with projects (i.e. Salesforce, Trackwise, Master Control, IN-TRAK II).
• Requires proficiency in personal computer applications (e.g. Microsoft Word, Excel, PowerPoint, Access, Outlook).

Work Conditions / Physical Requirements:

• Ability to work, on occasion, in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
• Must be able to lift and carry up to 50 lbs., on occasion
• Must be able to use a computer up to 8 hours per day.
• 10 - 25% Travel, as needed.
  
  Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.