Openings >> Project Manager
Project Manager
Title:Project Manager
Labor Type:Contract
Posting #:TF-004570-HA
Location:Frederick, MD

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Immediate need for a Project Manager

Duration:      12+ Months

Location:       Frederick, MD


Key Responsibilities:

  • Project Management: Sit on project core teams as Operations/Quality team member.
  • Manages projects within established scope, schedule, resources and budget.
  • Complies with company quality management systems, policies and procedures.
  • Coordinates and facilitates extended team project meetings with a structure and agenda that is specifically engineered to ensure successful execution.
  • Generates and disseminates meeting minutes which accurately capture key decisions, open issues and action items.
  • Follows up on status of task and action item execution both within and outside of meetings and updates project documentation (project timeline, meeting minutes) accordingly.
  • Proactively identifies any issues, concerns or challenges in regards to assigned project(s); develop action plans to address open issues, including escalation to key stakeholders as necessary.
  • Facilitates tradeoff decisions and removes obstacles.
  • Conducts proactive risk management via communication of risk based needs, mitigation plans, and requirements relevant to internal/external partners and stakeholders.
  • Demonstrates an ability to adapt to changing business needs and priorities, to be flexible with respect to job assignments and both functional and cross-functional responsibilities; specifically, shows active and timely participation in revising and refining assigned projects and responsibilities based on project or business changes.
  • Regularly reviews project team progress and uses processes, tools and other related resources to ensure effective team dynamics and decision-making, as well as effective interactions with all internal and external collaborators.
  • Builds high morale and team commitments to goals and objectives by creating a compelling sense of common purpose and direction.

Minimum Requirements:

  • 4 year degree in Genetics, Molecular Biology, Chemistry or related discipline
  • Minimum Qualifications (must have) Minimum of 5+ years working in product transfer or design transfer in an FDA regulated environment.
  • Knowledge of 21CFR820 and ISO 13485:2016.
  • Proficient with Microsoft Office applications (Word, PowerPoint, Excel,).
  • Strong negotiation skills; can effectively drive discussions and decisions toward desired results.
  • Outstanding orientation to teamwork: works collaboratively, effectively and efficiently with others.
  • Assertiveness to tactfully address concerns or conflicts openly within core and extended teams.
  • Must be willing to work in Frederick, MD, and must be legally authorized to work in the United States.
  • Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing projects and priorities.

Preferred Qualifications (nice to have):

  • Minimum of 5+ year’s program management within FDA regulated environment
  • Experience with Next Generation Sequencing.
  • Solid knowledge of manufacturing and quality processes.
  • Work background in quality regulated ISO, GMP and/or CLIA environments
  • Proficient with Microsoft Office applications (Visio, Project).


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