Sr. Program Manager (R&D)

Axogen is hiring for an Sr. Program Manager (R&D) in Tampa, FL!

Job Summary of the Sr. Program Manager (R&D)

The Sr. Program Manager is responsible for the overall coordination and management of the company’s key high visibility operational, infrastructure or regulatory programs. This individual will directly lead multiple large programs. Each program consisting of multiple workstreams and projects within the program and will be accountable for ensuring all workstreams and projects achieve established milestones leading to successful program delivery. Good interpersonal and excellent communication skills is a key success factor for this position. The program manager will prepare and lead program reviews and updates with core team and Executive team to ensure stakeholder alignment and timely issue identification, escalation and resolution; pro[1]actively manage and resolve conflict.The Sr. Program Manager reports directly to the Director, Program Management. In addition to managing an assigned program, this individual will support Axogen’s program management group in development and implementation of PM systems, processes and templates.

Requirements of the Sr. Program Manager (R&D)

• Bachelor of Science degree in engineering, technology, or scientific background is required.
• Minimum of 10 years project management experience in tissue engineering, medical device, biologics or pharmaceuticals is required.
• Operations, CMC experience preferred, BLA/PMA project management experience preferred.
• Demonstrated ability in effectively leading multiple mid to large scale projects and programs in one of the following areas: R&D, Operations, CMC, Regulatory, Infrastructure, Quality Systems
• Strong aptitude to drive cross-functional teams in a fast-paced environment to achieve tangible results
• Experience with Microsoft Office including Microsoft Project is required
• Track record of achieving results via influence and building relationships in a dynamic, matrix environment
• Must demonstrate strong interpersonal, conflict resolution and communication skills with various levels of the organization
• Must possess the ability to balance differences and conflicts between multiple stakeholders.
• Knowledge of biologics/drugs regulatory pathway is strongly preferred
• PMP certification strongly preferred.
• ProChain/Critical Chain Methodology experience is preferred

Responsibilities of the Sr. Program Manager (R&D)

The specific duties of the Sr. Program Manager (R&D) include but are not limited to:

• Lead the core team for assigned program. Conduct weekly or bi-weekly team meetings
• Ensure individual projects and workstreams within the program are adequately resourced and have clear deliverables, deadlines and budget. Able to zoom out to ensure the relationships and dependencies between workstreams are clearly identified and de-risked for achieving overall program objectives
• Collaborate with workstream and project leads to build out and maintain a master program schedule.
• Drive project team and workstreams to achieving the established deliverables on time
• Work closely with executive sponsor of the program to create program budget. Work closely with finance on expense tracking and reporting variance in monthly business review for the program and recommend any adjustments as needed.
• Clearly identify and drive alignment within workstreams and team members on key deliverables, dates, budget, risks and mitigations. Maintain program dashboard and provide timely and targeted updates to the Executive team.
• Maintain risk register for the program - Identify risks and mitigation plans; Pro-actively mitigate risks to ensure program stays on track or exploit any opportunities that can result in program achieving deliverables ahead of schedule or under budget.
• Drive clarity of deliverables and schedule with key stakeholders to ensure resources availability.
• Work closely with third parties – vendors, suppliers, consultants and ensure the work is completed in accordance with program schedule.
• Develop foundational project management systems. Be a mentor/teacher for project leads. Be a resource for and coach project leads in charter development, planning, scheduling, resourcing, PM tools and tips.
• Lead new product development programs, as the project manager, through all stages of the R&D continuum from feasibility to commercialization. This will include collaborating with key stakeholders to develop and integrate clinical (pivotal and supporting), marketing, regulatory, IP, operational & financial project plans into overall program.
• Work closely with cross functional project team to achieve deliverables to plan
• In collaboration with Director/VP, New Product Development, maintains Axogen’s stage gate based new product development process. Prepare cross functional team and lead program reviews through phase gate process.
• Work closely with technical lead to conduct timely and successful design reviews.

Location

111 West Oak Ave., Tampa, FL  33602

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Benefits/Compensation