Project Manager Laboratory Operations W2 ONLY 7624616
South San Francisco, CA
W2 ONLY 12 Month Contract
The Project Manager (PM) will support the Lab Operations Group in implementation of continuous improvement initiatives for quality and regulatory compliance and efficient laboratory operations. The PM’ s responsibilities are to facilitate effective planning and to drive execution of activities and closure of actions. The PM must be highly organized and detail oriented, and is responsible for creating, organizing, and maintaining project information and documentation. The PM is a critical interface with vendors/suppliers and our client’ s global colleagues, facilitating effective communication and maintaining positive team dynamics to enable on time execution.
· Manage moderate-scale team and projects of high complexity.
· Develop realistic project plan/schedules.
· Define, oversee and track Team’ s progress in meeting milestones and deliverables.
· Maintain project repository sites, contacts, and documentation.
· Create tools as needed for continuous project management improvement and tracking
· Interface with vendors/suppliers appropriately for activities such as supplier qualifications, scheduling activities, alignment of deliverables, and quote generation.
· Interface with our client’ s global colleagues
· Partner closely with Lab Operations Manager, Project Team Leads, Technical Manager, and Engineers to define and execute the strategy
· Schedule and facilitate team meetings and write and organize minutes and documents
· Ensure assigned tasks and action items are completed in timely manner
· Support equipment qualification project for a variety of laboratory equipment, including complex, computerized laboratory equipment.
· Support electronic method files migration and computer system upgrades
· Support test method validation and alignment projects
· Support device laboratory instrument and procedure improvement initiatives.
· Support device laboratory team for all audit related activities
· Provide technical administrative support for laboratory systems and procedures
· Be accountable for behaviors described in our client’ s Core, Common and Critical Competencies.
· Complete required training based on business/project need.
· The PM is expected to support project activities while onsite 5 days a week.
· Prior experience working in laboratory or process engineering technical role is highly desirable.
· Experience in combination products or medical devices is highly desirable.
· Project Management: Project planning, scheduling, tracking team deliverables and actions, facilitating team decisions, risk management, resource and cost forecasting, meeting management, regular project status communication, PMP certification (preferred)
· Software tools: Google mail, calendar, drive; Microsoft Office, Visio, Project
· Knowledge of regulatory standards: International standards (e.g. ISO 13485), FDA 21CFR820 and 211, Drug Development processes, Design Controls, GDP/GMP,
· Knowledge and experience in implementing and applying GMP laboratory controls is a plus
· Highly organized and detail oriented.
· Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, ever-changing, team-based environment.
· Excellent oral and written communication skills (listening, negotiation, presentation, organizational and relationship-building, etc) are required.
· Flexible in problem solving
· Able to integrating science, drug and device development knowledge and regulatory expectations to execute project plans.
Education and Industry Experience:
· BS/BA (Engineering/Science preferred).
· Minimum 3-5 years of related PM experience working in a manufacturing, laboratory and/or engineering environment within the biotech/pharma/medical device industry required.