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GMP Raw Materials Area Specialist I

4 months ago

Lebanon, Oregon, United States Novo Nordisk Full time

About the Department
At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do.
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 12 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
Secure existing & future supply of raw materials to Novo Nordisk production sites through transfer of materials between existing production entities whilst expanding new materials & new suppliers. The role requires knowledge within natural science, & a keen interest in ensuring high quality raw materials for Novo Nordisk US.
Relationships
Reports to Director, US Sourcing Hub.
Essential Functions

  • Responsible for raw materials & purchasing API for production in Novo Nordisk US
  • Support in setting the specification for our raw materials based on the use at Novo Nordisk to ensure compliance & patient safety
  • Participation in approval of new materials & new suppliers
  • Support & contribute to the quality control strategy for new materials
  • Evaluating material change notifications from suppliers
  • Representing the team in projects across the US organizations
  • Prepare proper documentation of activities to ensure inspection readiness
  • Other accountabilities, as may be 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.)
Qualifications

  • BS in science (e.g., chemistry, pharmacy, engineering), or another relevant field within the natural sciences; or equivalent combination of education & experience
  • Minimum of three (3) years progressively responsible experience in material management &/or GMP quality, required
  • Experience in one or more of the following areas desired:
  • Chemical engineering
  • Pharmaceutical sciences
  • Industrial ingredients
  • Chemistry
  • Pharmaceutical Production or laboratory, or other regulated industry
  • API & raw materials
  • Regulations GMP &/or ISO
  • Pharmaceutical or other FDA regulated industry
  • Demonstrated experience with control of raw materials & good manufacturing practice (GMP)
  • Demonstrated experience with pharmaceutical raw material &/or API
  • Knowledge within systematic problem solving & acumen for process optimization
  • Ability to identify solutions that are robust & will ensure the correct quality level
  • Excellent proficiency in English - written & verbal
  • Demonstrate action-oriented behaviors
  • Collaboration with colleagues & stakeholders across functions & departments
  • Work in structured manner & take ownership of assignments
  • Result-oriented & take pride in delivering on milestones
  • Motivate colleagues through positive, forthcoming attitude


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.