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    CMC Program Development Manager - Colorado, United States - Novo Nordisk

    Novo Nordisk
    Novo Nordisk Colorado, United States

    2 weeks ago

    Default job background
    Full time
    Description

    About the Department

    The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the hub for all manufacturing-related activities for GalXCTM and GalXC-PlusTM investigational therapeutics developed from Novo Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year by U.S. News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the world's leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change. Are you ready to make a difference?

    The Position

    Experienced Project Manager that can manage complex projects within budget, on time, & within scope. Manage multiple projects simultaneously. Ensure projects are executed & staffed according to project plans. Support Line of Business in developing project roadmap & area master plan. Indirect reporting to CMC Leadership with 1:1s, roadblock resolution, risk reporting, & overall first level of project guidance.

    Relationships

    Reports into Director, CMC Program Development.

    Essential Functions

  • Project Management
  • Lead programs, or series of related projects spanning multiple years, with specific oversight of quality, delivery, & cost.Coordinate contract resources & internal resources
  • Partner with cross-functional teams to visualize project roadmaps (i.e. 1-3 year plan) & master plan (3+ year)Provide clear goals so that the project secures effective use of time & resources & builds employee motivation
  • Lead communications for cross-functional stakeholders related to overall project deliveryResponsible for financial project accountability through purchase order creation, management, invoicing & cost forecasting
  • Lead multi-disciplined project teams to complete projects on-time, on-budget, meeting all requirements (quality, cost, schedule).Responsible for monitoring & reporting project progress, communications to management & other stakeholders, & presentation in steering groups
  • Coordinate contract resources & internal resources.
  • Manage vendors for outsourced manufacturing
  • Responsible for financial project accountability through purchase order creation, management, invoicing & program budgets
  • Responsible for monitoring & reporting project progress, communications to management & other stakeholders, & presentation in steering groups
  • Support local Quality Assurance unit activities
  • Business Process Improvements:
  • Manage activities of the local Business Process Improvements Committee, which aims to provide visibility to site issues to upper management and work with different teams to find solutions
  • Responsibilities include:
  • Meeting coordination and minutes
  • Action item documentation and follow-through
  • Working with other departments in Lexington and Denmark for issue resolution
  • Working with the team to generate presentations with committee to upper management
  • Managing input from Boulder site employees Physical Requirements Percentage of Travel: 10%. Qualifications
  • Education: BS degree in a science discipline. Advanced degree in the Life Sciences or related field preferred. 5+ years of relevant working experience required.
  • 2+ years of proven project management experience
  • Experience in pharmaceutical or biotech environment
  • Experience in Quality systems and management a plus
  • Excellent technical writing & oral communication skills; presentation & facilitation skills; & negotiation & conflict resolution skills.
  • Ability to work in both technical & non-technical areas.
  • Ability to use creativity to resolve problems that arise during project execution.
  • Understanding of product documentation & standard operating procedures.
  • Ability to create & manage work plans & detailed project schedules.
  • Strong analytical/reasoning, organizational & multi-tasking skills.
  • Demonstrated ability to communicate with key stakeholders in a cross-cultural environment & demonstrates superior written & oral communication skills.
  • Proficient in basic computer skills including experience with Microsoft Office.
  • Proven project management experience with direct management of multiple projects simultaneously.
  • Proven expertise in planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams.
  • Ability to function independently, as well as execution of good judgement in decision making & strong leadership skills.
  • Functions well in team environment. The base compensation range for this position is $100,000 to $150,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. The job posting is anticipated to close on 05/10/2024. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-

    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

    At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

    Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

    If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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