5 days old

Senior Project Manager- NPI - Single Use Bioprocess Development

Danaher
Marlborough, MA 01752

Help us improve access to life-changing therapies that can transform human health

We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.

Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.

What you'll do

The Project Manager is responsible for New Product Introductions (NPIs),and development projects to support growth of the business. In addition, this position is accountable for achieving quality objectives, creating/meeting development schedules and project budgets, as well as communicating program status and escalating issues when appropriate to facilitate transparency.

  • Leading cross-functional program activities for single use consumables, filtration (membrane and ultra filtration) and/or cost reduction projects with responsibility for timely completion within budget
  • Managing and optimizing project plans, product/project risk, project budgets, and resources/task assignments
  • Working closely with all support functions, effectively facilitating cross-functional decision making to deliver effective and timely new product development process results
  • Ensuring compliance with Design History File (DHF) and other QMS requirements
  • Managing customer critical-to-quality (CTQ) objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives
  • Aware of and comply with the Cytiva Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position


    Who you are

    • BS/MS Degree in analytical chemistry, or biomedical/mechanical engineering discipline.
    • 10 -15 years minimum relevant project/technical leadership experience with 5 years minimum NPI project management and execution experience.
    • Demonstrated leadership of cross-functional project teams, and an ability to drive project design plans to completion
    • Familiarity with ISO 13485, FDA and other regulatory standards


      Desired Characteristics

      • Experience and thorough understanding of NPI product development /product development lifecycle in a regulated environment
      • Strong written and verbal communication skills
      • Experience in one or more: film processing, sterile single use products, bio-processing, and/or medical device applications
      • Project management certification (PMP)
      • Experience managing or overseeing global resources and/or projects
      • Previous work experience in a matrixed-management/leadership environment
      • Experience with conflict resolution


        Who we are

        Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you€™ll feel right at home here. If you€™re flexible, curious and relentless, you€™ll belong. If you are excited about a global culture, this can be the place to further your career.

        Want to know more? Take a look at our Instagram, Twitter and LinkedIn pages!

        Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.

        As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher€™s unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life€™s Potential.

        Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Biotechnology

Categories

Posted: 2020-05-21 Expires: 2020-06-20

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Senior Project Manager- NPI - Single Use Bioprocess Development

Danaher
Marlborough, MA 01752

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