Location: Spokane, WA, USA
Company: Jubilant HollisterStier LLC
Job Position: Senior Project Manager
JOB DESCRIPTION:
Qualification:
Education & Experience
Bachelor of Arts or Science preferred majors Hard Sciences/Engineering OR 10 years related experience in lieu of degree.
- Minimum 2-year Project Management experience required for a Project Manager 3 years minimum for a Senior Project Manager.
- Project Management Professional certification required for a Senior Project Manager or certification must occur within 1 year.
- Must have 2 years Pharmaceutical and FDA Regulated Industry experience for a Project Manager OR 3 years for a Senior Project Manager.
- Must be proficient in Microsoft Word. Knowledge with Microsoft Excel, PowerPoint, and Project is desired.
Job Responsibility:
Comply with HS Project Management Guideline directives.
- Provide project leadership, coordination and support for multidisciplinary contract manufacturing teams.
- Mentor / direct Associate Project Managers.
- Ensure projects are kicked off appropriately and required technical transfer information has been delivered by the client.
- Ensure that a project schedule encompassing project scope and associated details is accurately developed and regularly maintained.
- Ensure equipment and components are identified and purchased in a timely manner.
- Ensure effective communication of project timelines, status and needs to all project team members and stakeholders typically per weekly teleconferences and associated meeting minutes.
- Communicate timeline and scope change concerns to HollisterStier Business Development and management.
- Monitor and report on component purchases, validation activities, process transfers, analytical transfers, and inspection, packaging and shipping requirements.
- Ensure daily communication of operational status and issues to affected staff and next higher level management.
- Ensure timely review and updates of manufacturing, validation and other documentation associated with the project.
- Verify manufacturing personnel are properly trained prior to project execution.
- Analyze and make recommendations regarding Project Management improvements.
- Interact with Quality Assurance and Maintenance departments to ensure production issues are dealt with promptly and with appropriate quality input.
- Ensure required activities are scheduled including equipment / component machinability runs, process walk throughs, demonstration and production runs and validation of processes and equipment.
- Ensure that Manufacturing has the required components, manufacturing documentation, and training prior to the manufacture of any batches.
- Meet and maintain requirements for GMP manufacturing and comply with GMP guidelines.
- Accompany client in plant throughout process.