South San Francisco, CA | Contract
Bayside Solutions is seeking a Project Manager to be part of our client’ s team in South San Francisco. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to save patients’ lives.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
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 is a critical interface with vendors/suppliers and global colleagues, facilitating effective communication and maintaining positive team dynamics to enable on time execution.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Manage moderate-scale team and projects of high complexity.
- 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 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.
- 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 the company’ s Core, Common and Critical Competencies.
- The PM is expected to support project activities while onsite 5 days a week.
- 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.
- Prior experience working in laboratory or process engineering technical role is highly desirable.
- Experience in combination products or medical devices is highly desirable.
- 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.
- Able to integrating science, drug and device development knowledge and regulatory expectations to execute project plans.