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Senior Project Manager - Cell Therapy

Facility:  General Management and Administration
Location: 

West Lebanon, NH, US

About the Department     

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

 

The Position

Novo Nordisk continues to grow! At our facility in West Lebanon, NH we are in the initial phases of building a new pilot and production suite for a brand new cell line that will be brought into the facility. To do this, we are looking for a Sr. Project Manager to lead Tech Transfer, Qualification and Submission for  this New Product line and Large Process/Process Equipment build out at our facility. The person in this role will be responsible for managing and executing this large-scale project from scope development and project planning through project closeout Accountable for engaging project teams and maximizing utilization of available resources associated with assigned projects. Act as the central resource for information flow between all project stakeholders (domestic and international) at varying levels (core team to Senior Leadership).

 

Relationships

Reports to: According to the organizational chart

 

Number of subordinates with direct/indirect referral: n/a

 

Essential Functions

  • Establish and own project plans for activities regarding product/process driven projects at NNUSBPI, ensuring complex decisions are made timely and key deliverables are executed according to plans
  • Planning and management of the project and its project team on a day-to-day basis, and is the primary resource and authority for the project team
    • Lead project scope and objective definition in concert with project champion(s) and key stakeholders
    • Develop, communicate, and manage adherence to project scope, schedule and budget
    • Accountable for incorporating appropriate risk management into all stages of project (planning, execution, closing)
    • Conduct start-up meeting with project staff to assign duties/roles
    • Act as advisor to project team to develop appropriate resolution to technical, schedule, budget and/or resourcing problems
    • Establish appropriate Key Success Indicators and manage trade-offs between scope, quality, time and cost
    • Communicate and control project progress and adherence to schedule
  • Work closely with Engineering, Manufacturing, Facilities, Manufacturing Sciences & Analytical Technology, Quality Assurance, Quality Control, Validation, and Regulatory Affairs (if required) on project teams to facilitate design, transfer, start-up and approval of manufacturing or business process changes
  • Participate in Product Supply Core team for projects to ensure alignment throughout entire project from API, Filling, Device, packing and Launch, as representative for NNUSBPI
  • Contribute to the development of tools/techniques to enhance the project management processes
  • Ensure compliance with the Quality Management System during project execution (includes developing and managing change control documentation)
  • Assure that all activities comply with established company and/or regulatory procedures, practices and guidelines
  • Lead the tracking and reporting of project activities, such as status reporting, resource allocation, milestone reporting, and benefit tracking
  • Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
  • Incorporate the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

 

Physical Requirements

0-10% overnight travel required. The ability to climb, balance, stand, walk, and finger. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. Lifting up to 33lbs/15kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Visual acuity to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: noise, inside and outside conditions including temperatures below 32 degrees F; close proximity to manufacturing equipment, moving parts, moving vehicles, and chemicals; atmospheric conditions including: odors, fumes, and dust. The ability to function in narrow hallways and spaces.

 

Novo Nordisk requires all employees to be fully vaccinated with a COVID-19 vaccine by December 8, 2021.  As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment.
 

Qualifications

  • Education and Certifications
    • Master’s Degree (Master of Science/Master of Business Administration) or equivalent with a minimum of ten (10) years’ experience or a Bachelor’s Degree in a technical discipline with a minimum of 12 years’ experience in an engineering or scientific discipline in a Current Good Manufacturing Practice (cGMP)/ regulated pharmaceutical or biotechnology industry
  • Work Experience
    • Minimum of 5 years of Project leadership experience in a matrix management environment with specific experience in development, validation, start-up and continuous improvement of manufacturing processes or analytical testing methods is required
    • Experience with the use of Project Management Body of Knowledge (PMBOK) methodologies and/or Lean/Six Sigma and tools in the context of project planning, execution and controlling
  • Knowledge, Skills, and Abilities
    • Develop and administer scope, budget, schedule and performance metrics for all projects
    • Ability to interact with functional peer groups at various management levels, including presentations to Senior leadership
    • Demonstrated ability to act independently and to navigate teams to data driven decisions and resolutions of complex issues
    • Adaptability to respond to changes in project expectations in a methodical and professional manner
    • Ability to decompose strategic level objectives into tactical level plans and facilitate plan execution

 

Millions rely on us 
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.