A leading pharmaceutical and medical device company is seeking a junior-level Project Manager to join its Denver-area team. Responsible for coordinating FDA filing efforts across multiple sites in North America
The Project Manager is accountable to the Director of Project Management, North America, and is dotted line accountable to Director of Production, Louisville. This role supports a range of cross-functional projects in operations related to strategic initiatives, new business development, third-party manufacturing, product launches, process improvements, and manufacturing compliance.
PRIMARY DUTIES AND RESPONSIBILITIES
Coordinates activities and supports operations projects for processes and equipment, outside of routine production, and related to the following business drivers:
- New business development (e.g. Novocol Healthcare or other Septodont Group companies)
- Third-party manufacturing,
- Technology transfer,
- Product launches,
- Process improvements,
- Inter-site harmonization,
- Manufacturing compliance.
- Leads cross-functional teams throughout project lifecycles to achieve project goals according to business objectives, timelines, and budgets. Works closely with others in positions such as Production Managers, Process Specialists, Project Specialists, and departmental Project Leaders to deliver projects.
- Facilitates collaboration between suppliers, customers, and subject matter experts throughout project life-cycles. Corresponds with external contractors, vendors, and other third parties according to project requirements.
- Supports the creation and maintenance of project charters, action plans, project schedules, resource planning and tracking, meeting minutes, presentations, and reports.
- Authors protocols and executes various studies, such as production trials, technology transfer studies, and qualification studies according to established policies and procedures. Participates in the analyses, interpretations and conclusions, and generates reports.
- Authors other project-related documentation, and participates in project-related SOP development.
- Ensures that project time and material expenditures are validated and tracked against operating budgets for assigned projects and reconciles discrepancies.
- Reports project metrics for business development reviews and key performance indicators.
- Generates and coordinates project-related documentation and ensures related department records, specifications, batch records, and SOPs are kept in compliance with Company, FDA (and other regulatory as applicable), health and safety, and legal requirements.
- Follows safety rules and regulations and reports any workplace injuries or accidents immediately.
- Maintains a high level of pharmaceutical and regulatory compliance in all aspects of work.
- Works harmoniously with all fellow employees.
- Performs other related duties as required by the Director of Project Management or Director of Production.
- Project Management Professional (PMP) certification or similar project management training preferred. Lean manufacturing experience is an asset.
- Ability to work in and lead multi-disciplinary teams and work independently. Ability to contemporaneously support multiple projects.
- Excellent communication, interpersonal, and organizational skills. Effective meeting facilitation and presentation skills.
- Demonstrates initiative, ownership, effective problem-solving, self-motivation, and is a team player.
- Proficiency with Microsoft Office applications, including Project, Excel, Word, Visio, and PowerPoint.
- Ability to motivate and train others.
- Bachelor of Science or Engineering / Engineering Science degree from a recognized academic institution is a requirement.
- A minimum of 1 to 2 years of experience in leading projects or initiatives in a manufacturing environment. Pharmaceutical, cosmetics, food/beverage experience strongly preferred.