Sr Project Manager - Technical, New Product Introduction (NPI)

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Job Summary:

This position is key to driving execution of New Product Introductions of consumable products from Concept Phase through and Transfer Phase, reporting to New Product Introduction (NPI), Program Management Office (PMO) within Global Operations. The Sr. Project Manager-Technical will work with an established phase gate product development process to ensure programs meet schedule, quality, scope, and cost targets. Successful Project Managers are able to lead and work collaboratively with program “Core Team” members from various functions (Product Marketing, Development, Operations, Quality, Customer Support, etc.) to successfully drive new products to market under aggressive timelines. The successful candidate must be able to work independently, handle multiple programs in parallel, and communicate effectively with all levels of the organization.

Responsibilities:

• Drive management of Platform RUO and Clinical Genomics portfolio and underlining programs and projects from Concept phase exit through Transfer phase exit for large cross functional teams
• Drive program team through PDP phase gate reviews that require executive approvals
• Lead detailed planning sessions to identify deliverables through work breakdown structures, identify interdependencies & gaps in scope for large cross functional teams and develop POR schedule with buffer and identification of critical path
• Lead detailed planning sessions to adequately resource programs across multiple business groups
• Lead detailed planning sessions to budget OpEx and CapEx quarterly throughout life of NPI
• Maintain resource management plan throughout life of NPI through monthly demand & allocation updates with focus on gaps impacting milestones and clear mitigation plans
• Maintain budget throughout life of NPI through monthly updates, focusing on achieving OpEx targets for company
• Develop and maintain Program Risk register throughout life of NPI, focusing on risk mitigation planning and execution
• Ensure successful execution of program plans, track, manage and communicate progress against contract targets to team and stakeholders
• Lead daily stand ups for high priority program deliverables
• Track, manage and communicate plan changes to team and stakeholders
• Problem solve through ambiguous situations and worst case scenario plan
• Work effectively with stakeholders to ensure program goals are in alignment with business objectives
• Interface with Engineering, R&D, Quality, Supply Chain and Regulatory to ensure project activities are completed on time and meet performance goals
• Translate detailed technical information into high level dashboards and executive review content
• Report to Upper Management regularly on project and portfolio status
• Coach and facilitate functional group members in carrying out their responsibilities on various project teams

Requirements:

• Minimum 3-5 years of functional operational experience within biotech, pharmaceutical, medical device and /or life science industries
• Minimum 3-5 years or project management experience, preferably in new product introduction experience
• Clinical, Biologics, and/or IVD development experience required
• Ability to work in dynamic environment where program plans pivot and concessions need to made to achieve business objectives
• Successful track record of bringing new technology/products to market
• Fundamental knowledge of pFMEAs and risk mitigation
• Fundamental knowledge of manufacturing equipment validations
• Interpersonal and facilitation skills- proven ability to effectively build relationships and achieve consensus across a wide range of functions and constituents
• Effective meeting leadership skills- proven ability to lead discussions with defined agendas, clear problem statements, desired outcomes and time management
• Risk Management- Ability to identify and prioritize key technical, schedule and business risks as well as respective mitigation plans
• Communication- Must be able to identify target audiences & effectively communicate at all levels of the organization
• Business Knowledge - Sound grasp of the key operational business drivers and considerations in the biotech, pharmaceutical, medical device and /or life science industries
• Leadership – ability to identify key issues, motivate and empower others to address them in a way which builds morale, generates ownership and commitment
• Self-starter with superior problem-solving, analytical and organizational skills and a track record for high performance and superior delivery
• Strong quantitative and qualitative skills; detail-oriented with ability to see the big picture and to work effectively at both high and detailed levels
• High level of expertise in MS Project, Excel, and Confluence for reporting progress to plan
• Familiar with developing business cases, project plans, resource strategy, and risk strategy

Education:

• Requires a minimum of 3-5 years of related experience with a Bachelor’s degree; or 1-3 years and a Master’s degree; or a PhD without experience; or equivalent work experience
• Preferred Qualifications: PMP Certification - or willingness to obtain a PMP

Desirable:

• Portfolio Management experience
• PMP Certification – or willingness to obtain a PMP
• Biopharmaceutical, Biomedical, IVD, Medical Device, experience
• Product Design Development & Transfer experience