Senior Manager, MDEV LCM & QC - ET - Novo Nordisk

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 Emerging Technologies - Oral Finished Products facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. OFP maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

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

Establish a satellite team in Manufacturing Development Life Cycle Management (Mdev LCM) in Emerging Technologies (ET) for the production site. Lead strategic activities ensuring new products can thrive without disrupting the production of existing products. Ensure local support and optimization of our solid dosage formulation production in interface with the sites across the world, driving the stability portfolio for all products, and writing and maintaining regulatory documentation.

Relationships

Director.

Essential Functions

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

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 chemistry, biological sciences, or related field of study from an accredited university is required
• Minimum of eight years(8) years of experience in Manufacturing, Manufacturing Technology/Development, and/or Quality  required
• Minimum of seven (7) years of leadership/management experience in the pharmaceutical industry/and or pharmaceutical chemistry laboratory required
• Technology transfers within pharmaceutical processes is preferred
• Knowledgeable in the following:  solid dosage formulation, GMPs and optimization techniques is required
• Experience with high volume pharmaceutical manufacturing is required
• Demonstrated attention to detail, proofreading & strong computer skills with a willingness to learn new IT applications is required
• Demonstrated knowledge of US & ISO regulations & guidelines, & applications of cGMP’s is required
• Demonstrated knowledge of pharmaceutical industry validation requirements including a thorough understanding of cleaning, equipment, utility, computer & process validation requirements & concepts is required
• Excellent written & oral communication skills & the ability to author scientific & technical reports is required
• Organization/Planning:
• Proven expertise in leading execution of a process, planning/organizing, checking results & creating the cycle plan in accordance with testing needs is preferred

• Agility:
• Ability to quickly change direction when business priorities or customer requirements change; exhibits a high level of flexibility when confronted with new or unexpected circumstances is required

• Appreciative:
• Gives others credit for their contributions & successes
• Effectively uses rewards & recognition to help individuals & team achieve desired results is 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.