Job Details:

Principal Specialist, API w/ Novo Nordisk Pharmaceutical Industries, LP in Clayton NC.

Serve as expert on department processes for the site. Own and develop department processes and equipment design standards. Support the Director in the creation, set up, and implementation of department processes. Coordinate overall validation strategy within the department. Advise department Director of potential problems to the department processes and propose solutions. Conduct overview of execution, requirements and quality parameters for the department processes and ensure adherence to these during operations. Participate in planning and execution of activities related to department validation activities and optimization projects. Participate in major deviation and quality investigations across the site. Liaise between the department, Manufacturing Development, & CMC. Secure technical transfer and continuous optimization of API processes within the department. Work with department Director, Mdev Project Office, & site CVP on capacity targets and optimization ideas. Serve as department Tech Transfer Team (T3) lead. Develop and maintain global network with API production facilities across Novo Nordisk. Serve as department representative in Product Supply Capacity steering groups. Ensure alignment on process execution between the US site and the DK facilities (within same product). Assist Senior Specialists develop process design, requirements and validation. Develop and implement strategies and standards for continuous improvement based on cLEAN® 3 Star/Six Sigma. Work on site-wide improvement projects with cross-functional teams.

Must possess a Bachelor’s degree or foreign equivalent in Pharmaceutical Science or a related field and minimum five (5) years of experience in fermentation and recovery related process/manufacturing in the pharmaceutical industry. Experience must include: Manufacturing development / R&D, Design of Experiment, Root Cause Analysis (RCA); Cell culture/propagation, SIP/CIP, Control/SCADA/PLCs, Process Improvement Methodologies; cGMP’s within process validation and equipment qualification. 

How to Apply:

Email resume to Novo Nordisk Pharmaceutical Industries, LP at JSLO@novonordisk.com, Ref# PSAPINC0519