Immediate need for a Project Manager
Duration: 12+ Months
Location: Frederick, MD
- 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.
- 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).