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Title:  Program Director, R&D, Combination Products

Requisition ID:  37241
Date:  Oct 25, 2021
Location: 

Scottsdale, Arizona, US

Department:  R&D
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

The Program Director, R&D, Combination Products has responsibility for collaborating with customers and internal stakeholders and jointly executing successful regulatory approval and launch of combination products. This role will develop a sustainable plan of execution for assigned combination product commercial programs with participation from commercial, product management, quality, regulatory and operations. Directing assigned cross-functional teams with constant monitoring and adapting to changing needs with appropriate risk management strategies.  This role is responsible for the management and reporting of all applicable data for the project/program. They will communicate at all levels of the organization and be responsible for recognizing and engaging key stakeholders and cross-functional resources throughout the process.

 

Essential Duties and Responsibilities:

  • Direct cross-functional teams, in the execution of customer specific combination product programs; in partnership with commercial, product management, quality, regulatory and operations
  • Provide support in the creation of development agreement (DA’s) for West device platforms for combination products in collaboration and participation from commercial, product management, quality, regulatory and operations.
  • Understands customers’ requirements and needs during a development agreement to define a standard method how West will communicate, track and monitor performance to customers and West stakeholder.
  • Establish and lead communication plan, governance and change controls with customer and West stakeholders to drive mutually beneficial and predictable results during combination product development process.
  • Conduct routine program management reviews with Project Teams & Sr. Management.
  • Coordinate resource allocation & constraints with functional managers, program managers.
  • Collaborate with supervisor/stakeholders to establish project priorities & meet timelines.
  • Analyze, forecast, and report program budgets in collaboration with program managers and functional managers.
  • Ensure the various teams are collaborating across the enterprise, across various groups, and builds a high-performance environment. 
  • Ensure that the West Product Development Process & methods are implemented on customer combination product development programs.
  • Communicates key messages, goals, and objectives to team members in their local geographies or business units to drive alignment and a high-performance culture. 
  • Performs other duties as assigned based on business needs.
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

 

 

 

 

 

 

Education and Experience:

  • Education: Bachelors in Engineering, Materials, Chemistry, or equivalent technical degree. MBA/Masters degree preferred
  • Experience: 10+ years of experience

 

Knowledge, Skills and Abilities:

        • Project Management experience &/or 5+ years Medical Materials, Medical Device &/or Drug Delivery Systems product development experience. 
        • Working knowledge of applicable federal & international regulations such as 21CFR Parts 210, 211, & 820. 
        • cGMP manufacturing experience preferred. 
        • PMP certification preferred but not required.
        • Proficient with Microsoft Office suite software, project management software such as Microsoft Project Server.
        • Working knowledge of 3D design applications preferred.

 

Physical and Travel Requirements:

        • Must be able to travel to domestic & international customers as well as West manufacturing locations as project requirements & business needs require.
        • Work in an office/home office environment.  At times required sit or stand for extended periods of time. 
        • Ability to effectively communicate and comprehend complex ideas and concepts. 
        • Use written and oral communication skills. 
        • Read and interpret data, information, and documents. 
        • Must maintain the ability to work well with others in a variety of situations. Strong ability to build and maintain solid work relationships. 
        • Must be able to multi-task, work under time constraints, problem solve, and prioritize. 
        • Ability to make independent and sound judgments. 
        • Observe and interpret situations, analyze, and solve problems. 

 

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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