Project Director, Aseptic Production - FFEx (Bloomington, IN)

Posted 2 Days Ago
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Bloomington, IN
Senior level
Healthtech • Software • Pharmaceutical
Join us as we drive change to combat serious chronic diseases.
The Role
The Project Director will lead and manage all processes related to Aseptic Production, overseeing design, build, and qualification of filling capacity. Responsibilities include project management, team leadership, budget presentations, compliance, and staff development within a global expansion framework.
Summary Generated by Built In

About the Department
You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk's 50,000 employees.
FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.
What we offer you:
• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance - effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Provides direction, leads, & manages the development & implementation of all AP processes including Filling, Formulation, Wash & Sterilization, & Inspection as part of the overall Site Expansion program. This position will be responsible for building the strategic organization to support the design, build, FAT, SAT, & Qualification of all AP process equipment for AP expansion through release & turnover to system owner. Incumbent will be a key role integrated into the project management & execution team. Will lead the work package owners for the areas listed above as well as the technical/engineering team through oversight of an organization comprised of large project team to include NNPILP Full-time Employees & Contractors.
Relationships
Reports to Fill & Finish Expansion Head. Member of the Senior Leadership Team for the FFEx.
Interacts with global counterparts in other FFEx projects as well as with Manufacturing Development, Supply Chain, Regulatory Affairs, Quality Assurance.
Essential Functions

  • Lead, direct, & coordinate the project management & facilities engineering team in the design, build, install & qualification of all AP processes including implementation of new products within the facility
  • Design, install & qualify all AP processes including implementation of new products within the facility
  • Develop Gate presentations & present all new expansions to IFP management as well as PS management to secure budget for execution of expansion
  • Develop the organization to support the expansion project ensuring that required resources to execute multiple filling lines are staffed
  • Identify & develop working relationships with affected customers at all levels; ensure that customer representatives are kept appropriately informed of project activities & are encouraged to participate as appropriate
  • Ensure compliance with NN Quality Management System & PS Environmental, Health & Safety Management system
  • Design, establish, & maintain an organizational structure & staffing to effectively accomplish the goals & objectives of the project
  • Recruit, train, oversee, & deploy technical & functional staff
  • Develop & manage the transition work plans for all project team members, to include transition into the project & back to home departments upon completion
  • Oversee the supervision of project personnel, which includes work allocation, training, & problem solution; evaluate performance & make recommendations for personnel actions; motivate employees to achieve peak productivity & performance
  • Follow all safety & environmental requirements in the performance of duties
  • Other accountabilities as assigned


Physical Requirements
Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)
Development of People
Supervisory
Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications

  • Bachelor's degree in Engineering/Economics/Business Administration from an accredited university required
  • Minimum of ten (10) years of proven & successful project management experience required, including the following:
    • Knowledgeable in core work processes & GMP concepts required
    • Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts required
    • Demonstrates functional/business understanding as well as superior written & oral communication skills required
    • Extensive knowledge of project management including the ability to create work plans & detailed project schedules required
    • Proficient in problem solving, negotiation, conflict management & interpersonal skills required
    • Ability to act as project lead & lead cross functional project teams in the development & implementation of projects required
    • Ability to influence others on objectives & projects outcomes required
    • Basic understanding of contractual documents required
    • Ability to read/review design drawings (CAD) with a basic understanding of P&ID's required


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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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The Company
HQ: Bagsværd
69,000 Employees
Hybrid Workplace
Year Founded: 1923

What We Do

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease.

We are powered by technology. Our Global Research Technologies, Medical Devices as a software, and Data Science teams are on the cutting edge of developing and supporting our life-saving medications.

Why Work With Us

Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat.

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