Manages the product commercialization process/new product development and introduction through the phase-gate process, managing scope, schedule, risks, issues, trade-offs, communications, and expectations.
Represent the organization in assuring the teams follow product development best practices, and in some cases adhere to specific regulatory requirements, as they lead project teams through the product commercialization process (PCP). This includes assuring design control and thereby long-term product supportability, as well as delivering the agreed upon business value.
Drives the use of project management best practices, with the goal of not only delivering a product of high quality and value to the organization, but delivering within the agreed upon project contract metrics of schedule, resources, budget and scope.• Lead, manage, coordinate, synchronize, and be accountable for the execution of programs from Customer engagement through to Product Delivery / Launch & Program Closure.• Coordinate multiple projects and/ programs simultaneously• Act as information conduit between the Core Team and Sr. Management. Influence stakeholders in a highly matrixed organization.• Prepare and present formal Program Reviews as well as overall Custom Program Pipeline updates to Sr. Leadership; initiates Exception Reviews as necessary.• Lead teams to define and prioritize scope, objectives, and requirements.• Plan resource requirements and negotiate Core Team resources with functional managers; assist Core Team Members in negotiating extended team staffing.• Develop accurate, actionable, and cross-functionally integrated program plans based on business goals, constraints, and risk tolerance.• Drive risk assessment, communication, proactive mitigation planning, and contingency response planning.• Regularly track, monitor, and communicate team progress against requirements and plans to all stakeholders; resolve deviations; schedule and lead core team meetings.• Assist Core Team Members in resolving extended team and functional issues.• Collaborate and coordinate across all the functional areas (R&D, Product Management, QA/QC, Regulatory, Legal, Operations, Manufacturing, Service and Support and others) necessary to insure successful program completion.• Lead, document, and communicate constructive lessons-learned analysis of completed programs.• Build effective relationships with core and extended team members, functional managers, senior management, and customers.• Contribute to performance evaluation of Core Team Members.• Other duties as assigned.

Education
Bachelor's degree in a science discipline or related field of study, or equivalent experience. Master's degree a plus.

Experience• Minimum 8 years of product development experience in Life Sciences, Biotechnology or Medical Devices; IVD experience highly preferred.• Minimum 5 years of program management experience.• Phase-gate product development process experience.• VOC process experience preferred.• PMP certification preferred.

Knowledge, Skills, Abilities
• Ability to distill, prioritize, and act on feedback from a variety of sources.• Ability to do the right thing under pressure and tight deadlines in a complex, matrixed environment.• Ability to work independently without significant direction• Excellent critical thinking, troubleshooting, crisis management, and decision-making skills.• Excellent interpersonal and relationship building skills, and the ability to work effectively with a variety of other personal styles.• Excellent leadership skills particularly the ability to influence stakeholders in other functions over whom the Program Manager has no direct managing authority.• Excellent oral and written communication skills.• Initiative. Self-motivated and independent thinker that routinely translates circumstances and understanding into actions that move the business forward in a measurable manner.• Meticulous attention to detail and a passion for driving execution at a detail level when necessary while maintaining the ability to see the big picture.