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Roche
Tucson, AZ, United States
29 days ago
Roche
Tucson, Arizona, United States
29 days ago

Description

The New Product Introduction Senior Manager leads a team of Scientists and Engineers that coordinate with Development, Regulatory and Project teams at Roche to launch new Assays, Reagents and Bulk materials used in tissue diagnostic tests as well as the launch of new diagnostic platforms. This leader, with their team develops and implements operations requirements for design transfer across all product portfolios and collaborates with development, manufacturing and technical support teams to assure that all aspects of design for quality and manufacturability (DQM) are utilized for robust design development, transfer and ultimately scale up. Assures appropriate test method validations and product specifications are developed and implemented. Individual is also responsible for managing new part number creation and appropriate work instruction development.

Provides leadership of design transfer activities of products developed by other BA's to RTD OPS. Also engages in technology transfer activities involving product end of life or transfer to other Roche manufacturing site.

Works cross functionally to ensure repeatability and reproducibility of the manufactured products within product and process capabilities and meeting desired specifications.


Responsibilities:

•Establishes overall team direction and goals, and sets direction of resources toward completion of goals, in conjunction with Director Assay Transfer and Senior Leadership in both Development and Operations. Promotes an open, collaborative environment focused on teamwork.
•Aligns on Reagent and Instrument life cycle project timelines in consultation with respective Operations Functional Leads. Establishes and maintains design transfer project milestones and timelines.
•Supports robust design specification development and validation activities during design transfer, working closely with counterparts in the development team..
•Ensures collaboration with supply chain and procurement teams for parts/components availability for initial production and scale up.
•Effectively communicates manufacturing related issues during design transfer to development team for quick resolution.
•Actively establish and refine Technology Transfer standard work to continuously improve the transfer process. Actively seeks out, creates and implements new ways to drastically simplify our ways of working within the team.
•Ensures that the team actively applies 6 Sigma and Lean Manufacturing Methods during the development phase.
•Actively explores new methodologies, equipment, processes to improve product quality and reduce product cost and improve new product introduction practices.
•Is a visible leader and provides staff with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations.

•Other duties as assigned by management. 

Relocation benefits are available for this job posting. 



Requirements

MINIMUM QUALIFICATIONS:

Formal Training/Education:

  • Bachelor’s degree in an Engineering/Engineering Technology or Life Science discipline degree required
  • MS in an Engineering/Engineering Technology or Life Science discipline preferred.

Experience:

  • Minimum of 10 years of demonstrated experience in people management and leadership role.
  • Minimum of 5 years experience in regulated industry preferably FDA and knowledge of Design Control guidelines.
  • 5 or more years of experience with Lean and Six Sigma methodology and technical project management experience

Knowledge, Skills, and Abilities:

  • Strong managerial, assessment and team building abilities.
  • Strong Conflict resolution and negotiation skills.
  • Ability to prepare departmental budgets & plan and allocate resources to support Lifecycle projects.
  • Ability to work on complex problems with analysis of situations or data towards successful outcomes.
  • Ability to present and discuss data, present alternative action/mitigation plan and clearly communicate recommendations to all levels of the organization
  • Strong written and verbal communication skills.
  • Excellent time management, planning, organization and problem solving skills.
  • Ability to manage a team of engineers, scientists and research associates working on diverse new products.
  • Demonstrated ability to lead, mentor and coach team members.

Job Information

  • Job ID: 64458412
  • Location:
    Tucson, Arizona, United States
  • Company Name For Job: Roche
  • Position Title: Manager Senior-New Product Introduction
  • Industry: Biotechnology and Pharmaceutical,Engineering,Engineering-Biomedical,Engineering-Industrial,Engineering-Manufacturing,Engineering-Mechanical,Manufacturing and Production
  • Job Function: Engineering,
    Manufacturing
  • Job Type: Full-Time
  • Min Education: BA/BS/Undergraduate

Please refer to the company's website or job descriptions to learn more about them.

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