Skip to main content

Manager, QC - OFP

About the Department

At Novo Nordisk, we want to make a difference. For more than 95 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.  Help us bring quality to life. We are currently seeking top talent for our new OFP tableting facility located in Durham, NC.

 

 

The Position

Manage all project activities & personnel related to the establishment & operation of the QC laboratory supporting analysis of OFP Site Durham materials, including responsibility for meeting all cost, quality & schedule requirements. Responsible for all validation/transfer activities associated with Chemistry analytical methods.

 

Essential Functions

  • Maintain plans to meet changes in customer requirements
  • Accuracy & Scientific soundness of Lab Data
  • Good Manufacturing Practice (GMP) Compliance of Lab
  • Lead team in successful execution of the testing processes
  • Coordinate with Director, QC & EM & other teams on workload issues & priorities
  • Frequent planning to ensure resources are in place to execute the plan
  • Ensure tracking & reporting of key performance indicators (KPI’s)
  • Communication with customers; ensure knowledge transfer & alignment with OFP and D&S DK & all other relevant stakeholders
  • Responsible for ensuring department documents are current & standardized
  • Support training & development of QC - OFP personnel
  • Provide guidance for & approval of Laboratory Investigations and deviations
  • Define User Requirements & ensure correct & timely Validation & Qualification activities
  • Responsible for building department’s competence house & training principles behind that 
  • Ensure implementation of cLEAN® principles in QC Chemistry
  • Other accountabilities, as assigned

 

Qualifications

  • BS/BA in chemistry, biological sciences, or related field of study, or an equivalent combination of education & experience

 
Desired Qualifications

  • Minimum of five (5) years of leadership/management experience in a clinical or industrial/pharmaceutical chemistry laboratory
  • Minimum of five (5) years of analytical GMP laboratory experience
  • Technology transfers within GMP laboratories
  • Knowledgeable in the following: Chemical analysis, GMPs & laboratory techniques
  • Experience with HPLC/UPLC & other chemical analytical procedures
  • Must demonstrate attention to detail, proofreading & strong computer skills with a willingness to learn new IT applications
  • Demonstrated knowledge of US & ISO regulations & guidelines, & applications of cGMP’s within Microbial area
  • Demonstrated knowledge of pharmaceutical industry validation requirements including a thorough understanding of cleaning, equipment, utility, computer & process validation requirements & concepts
  • Excellent written & oral communication skills & the ability to author scientific & technical reports
  • Proven expertise in leading execution of a process, planning/organizing, checking results & creating the cycle plan in accordance with testing needs

 

Physical Requirements

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility using various body positions.
  • Able to do close precision work with their hands.
  • Must be able to remain in a stationary position 50% of the time.  
  • Corrected vision to 20/30 & ability to see all colors.
  • Occasionally ascends/descends a ladder to take samples.
  • Occasionally works around odorous and/or hazardous materials.
  • Able to work in an open office environment with the possibility of frequent distraction.
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation.

 

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

 

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.

Manager, QC - OFP

Durham, NC
Full Time

Published on 02/12/2020