Project Director, Aseptic Production - FFEx (...
BioSpace - Bloomington, IN
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Job DetailsAbout 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 AwardsAt 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 PositionProvides 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.RelationshipsReports 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 FunctionsLead, 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 facilityDesign, install & qualify all AP processes including implementation of new products within the facilityDevelop Gate presentations & present all new expansions to IFP management as well as PS management to secure budget for execution of expansionDevelop the organization to support the expansion project ensuring that required resources to execute multiple filling lines are staffedIdentify & 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 appropriateEnsure compliance with NN Quality Management System & PS Environmental, Health & Safety Management systemDesign, establish, & maintain an organizational structure & staffing to effectively accomplish the goals & objectives of the projectRecruit, train, oversee, & deploy technical & functional staffDevelop & manage the transition work plans for all project team members, to include transition into the project & back to home departments upon completionOversee 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 & performanceFollow all safety & environmental requirements in the performance of dutiesOther accountabilities as assignedPhysical RequirementsAbility 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 PeopleSupervisoryEnsure 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.QualificationsBachelor's degree in Engineering/Economics/Business Administration from an accredited university requiredMinimum of ten (10) years of proven & successful project management experience required, including the following:Knowledgeable in core work processes & GMP concepts requiredUnderstanding of complicated product documentation & standard operating procedures with attention to high-level concepts requiredDemonstrates functional/business understanding as well as superior written & oral communication skills requiredExtensive knowledge of project management including the ability to create work plans & detailed project schedules requiredProficient in problem solving, negotiation, conflict management & interpersonal skills requiredAbility to act as project lead & lead cross functional project teams in the development & implementation of projects requiredAbility to influence others on objectives & projects outcomes requiredBasic understanding of contractual documents requiredAbility to read/review design drawings (CAD) with a basic understanding of P&ID's requiredWe 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.
Created: 2025-02-02