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Location: Rockville, MDAt 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 BioServices business unit of Thermo Fisher Scientific. The Associate Project Manager (APM) provides support to a Project Manager in managing projects / studies for customers and in the development of workflow processes between the customer and the business. Specifically, the APM assists Project Managers in study management across the organization and various departments, proactively working with all the parties involved in the study and in timeline management, milestone tracking and weekly updates to the customer. In some cases, the APM may take on full study management of a project coordinating across all technical and service aspects of a project.Essential Duties and Responsibilities:Works with the Client to finalize specifications. This may include meetings 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 business 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 with the Master Production Scheduler to optimize production of clinical supplies balancing the customer requirements with best use of available capacity.
Creates and/ or supports creation of batch documentation.
Provides back-up support to the Project manager.
Monitors project activities and day to day business as well as establishment of a customer approved Job Specification,
Collects all the information on a study design including correct label texts, coordination of primary, secondary packaging material and tools, coordination of label translation and producing all batch documentation for operations and check of documentation,
Coordinates shipments through the logistics department, writes Distribution order and GMP instructions in a timely manner.
Applies Good Manufacturing Principles in all areas of responsibility.
Demonstrates and promotes the company vision.
Basic Minimum Qualifications: 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 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 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, GPMS, Trackwise).
Requires strong interpersonal and communication skills to include excellent relationship building.
Requires proficiency in MS Office - Word, Excel, PowerPoint, Outlook, etc.
Requires proven experience with customers in a dynamic environment.
Requires excellent communication, organizational skills and project co-ordination skills.
Education/ Experience:College or university degree, in a health-related field preferred. High school diploma required.
Requires 2-3 years of successful experience in project management.
Prefer certification in Project Management by a recognized institution in projectmanagement.
Understanding of Project Management concepts and proficiency in appropriate project planning tools e.g. Microsoft Project to communicate milestones and critical path activities and responsibilities preferred.
Understanding of clinical trials preferred.
Supervisory Responsibility:None.
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.
Must be able to use a computer up to 8 hours per day.
10 - 25% Travel as needed.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.Apply today! http://jobs.thermofisher.comThermo 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.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.
Vacancy expired!