Release Coordinator - API

Facility:  Regulatory
Location: 

Clayton, NC, US

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.

 

Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!

 

Position Purpose

Contribute to the delivery of Active Pharmaceutical Ingredients (API) as agreed to in the site production and capacity agreements. Support the release of API by helping ensure the timeliness of release at continuously improving quality and cost. Ability to communicate release needs throughout the organization. Act as a project manager to ensure that all activities related to the release of a particular batch is coordinated with all stakeholders and contributing organizations, and all activities are performed in the most efficient and timely manner.

 

Accountabilities

  • Perform activities to support Batch Release
  • Coordinate with Supply Chain Planning to ensure that the agreed amount of API can be released in accordance with release and lead-time targets
  • Responsible for requesting status assignments of API batches and intermediate products and follow-up on lead-times. Collaborate with Production Responsible to ensure batch reviews are complete
  • Initiate applicable batch release checklists
  • Verify the completion of required batch documentation and document on the applicable checklist
  • Request status assignment for Drug Substance (K6)
  • Verify potency has been calculated and entered into SAP by production
  • Prepare overviews and presentations for stakeholders as to what is blocking release
  • Collect batch documentation in systems to include SAP, LIMS, and MES and update data as required
  • Ensure release documentation is in compliance with all applicable corporate and local SOPs
  • Provide guidance to stakeholders regarding batch release & related activities
  • Support systematic problem solving & participate / review cross-functional investigations
  • Participate in process confirmations & “Go Look See”
  • Participate in knowledge & experience sharing to assure collaboration, communication & creating results in relation to compliance with company procedures, policies & objectives
  • Develop reporting tools and key process indicators within the batch release area
  • Evaluate, trend & report data for continuous improvement in the release process
  • Perform other duties as assigned

 

Required Qualifications

  • BA/BS degree in Life Sciences, Engineering, Supply Chain Management, or related field
  • Excellent written & verbal communication skills
  • Excellent computer skills in MS Office, PowerPoint, Word, Excel, etc.
  • Able to develop, manage & achieve action plans; good negotiation, communication & collaboration skills

 

Desired Qualifications

  • Minimum three (3) years of experience in supply chain, quality, project management or related field
  • Previous experience and general knowledge in cGMP manufacturing & production processes
  • General knowledge in Batch Release Processes as related to pharmaceutical or cGMP production processes
  • Project management experience working with cross-functional teams
  • Application of cGMPs in pharmaceutical manufacturing
  • Knowledge of SAP systems (BW, APO, ECC) or similar ERP / material management systems
  • Proven Process Improvement and problem-solving skills
  • Experience in the use of Six Sigma & LEAN tools

 

Physical & Other Requirements

  • Able to move throughout the facility to perform duties in close proximity to process equipment & areas
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Able to work in an open office environment with the possibility of frequent distraction
  • Must be able to travel domestically & internationally, up to 10%

 

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.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

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.