Program Manager
Posted
Summary
Corium Innovations, a specialty pharmaceutical CDMO, is hiring an on-site Program Manager in Grand Rapids, MI to manage deliverables, timelines, and budgets across internal and external drug development programs. The role coordinates cross-functional teams, tracks financials, and ensures compliance with combination product regulations, using tools like Microsoft Project and the Office suite.
Corium Innovations is seeking a Program Manager who will be responsible for managing program deliverables, timelines and budgets for internal and external development programs and projects. This position will provide program management oversight for all stages of programs or projects to ensure the appropriate projects are moving forward based on their likelihood of success and progress. This position also includes coordination of cross-functional teams to ensure materials, equipment, processes, and methods are on schedule and within financial budget. This position ensures that programs and projects are kept visible at the appropriate levels of the organization and that cross-functional team members and leadership are aligned with objectives, decisions and challenges.
Your most Innovative career move is here!
At Corium Innovations, we’ve led the way in innovating drug delivery technologies for millions of patients whose GI systems just can’t tolerate pills, who can’t remember to take their meds as directed, or who have needle-phobia. This is only the beginning! There’s so much more to deliver, and we need YOU to do it!
Our Purpose is to create, develop and manufacture innovative healthcare products for partners that deliver superior value to patients.
Our Goal is to be the best-in-class specialty CDMO through the use of innovative technologies and superior execution.
Our Company Values are core to our positive and people-centric culture which inspires all of us to come to work every day on behalf of our people, our partners, our customers, and our patients. Through our four core values, we put people first and create opportunities to make each day better than the last.
- Celebrate Individuals: We’re looking for talent who will celebrate the uniqueness of each of our team members by encouraging everyone to bring their authentic self to work.
- Successful Together: We believe we’re better together, so we prioritize teamwork as we work to achieve our shared vision knowing each one of us has an important role to play.
- Embrace Innovation: We embrace new challenges and opportunities while encouraging creative thinking and innovative solutions to best meet the needs of our people and our partners.
- Pride in Ownership: We take pride in owning our progress and successes, feeling empowered to pursue our growth to reach our full potential. And we hope you will too!
Responsibilities:
- Requires and ensures compliance with the Product Development Process (PDP) thereby ensuring compliance to combination product regulations for development and commercial programs.
- Development of project scope, budgets and timelines with the input, support and alignment of cross-functional team members and leadership. Track, identify, and resolve scope changes as well as communicate these changes to internal and external partners and ensure appropriate leadership approvals.
- Coordinates internal and external project meetings, including agendas and minutes including action items and follow up as necessary.
- Provides project updates to internal management and partners.
- Participates in the strategic planning for long range projects, including business impact.
- Reviews project hours and out-of-pocket expenses, on a monthly basis, to ensure accurate time reporting and adherence to budgets. Work with management to address timekeeping and hour overages.
- Forecasts Financial performance versus budget and provides documentation for timing and costs overruns.
- Forecasts labor hours, using analytical tools, to understand potential labor overages or other issues.
- Supports the Finance Department with the month-end billing and authorization of invoices as they pertain to project deliverables and milestones.
- Responsible for long range financial planning for multiple projects or programs, including prediction of cash flow on a fiscal year (or longer) basis.
- Supports the cross-functional project teams in the structured and timely submission of regulatory applications and supplements.
- Supports partner, ISO, or regulatory audits / inspections to ensure team readiness for all inspections.
- Coordinates the scheduling, agenda, and minutes for Quarterly Business Reviews (QBRs)with partners as appropriate. Participate in QBR meetings, including providing executive level updates and presenting information to gain agreement on changes in scope, status, or direction of a project.
- Responsible for managing multiple projects or programs while objectively assessing progress, likelihood of success and alignment with corporate objectives. In doing so, makes recommendations for progression or remediation of programs and projects.
Qualifications:
- Bachelor of Science Degree; MS/MBA preferred.
- Specific PMP or other project management certification preferred.
- 6+ years related experience, with an advanced degree 5+ years of experience.
- Pharmaceutical Project Management experience preferred.
- Microsoft Word, Excel, PowerPoint, Outlook and Project.
- Strong operational knowledge of the product development life cycle with regards to new and generic drugs.
- Must be able to interact with individuals at all levels of the organization as well as external strategic partners and regulatory authorities.
- Must be able to maintain strict confidentiality regarding internal and external information.
- Must be detail-oriented and able to provide self-direction.
Benefits:
- Highly competitive benefits program including medical, dental, vision, flexible spending accounts, life insurance, disability insurance, and employee assistance program.
- 401(k) retirement savings account with a company match and immediate vesting.
- 12 paid holidays.
- Competitive paid vacation plan plus ~1 additional week of paid time off for our annual holiday shutdown.