Associate, API Manufacturing

Novo Nordisk•Boulder, CO

2d•Onsite

About The Position

The Associate - API Manufacturing works in Novo Nordisk's Boulder, Colorado manufacturing facilities and is responsible for the production of oligonucleotide API to support clinical trials. In addition to ensuring the supply of API and meeting production goals, the Associate actively supports continuous improvement initiatives and identifies wherever possible improvements that reduce risk and cost to the overall operation. The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Together, we are driving change. Are you ready to make a difference.

Requirements

High School Diploma or GED and 4+ years of experience, or Associate's degree with 2+ years of experience, or Bachelor's degree from an accredited university and 0+ years of experience required
A general understanding of cGXP and applicable regulations and guidelines is preferred
Mechanical aptitude with ability to use tools to perform tasks, basic troubleshooting of mechanical components and systems
Ability to work independently and within teams that consist of members with different degrees of knowledge or ability
Possess excellent written and verbal communication skills
Excellent organizational and multi-tasking skills, attention to detail, and the ability to adapt to changing priorities
Basic computer literacy including MS Office suite programs (Word, Excel, Outlook)

Nice To Haves

Experience using NN software systems (SCADA, SAP, LIMS, Veeva) is preferred

Responsibilities

Responsible for the manufacture of oligonucleotide API, ensuring compliance to cGXP, safety, regulatory, and business processes and/or procedures
Maintains a clean, safe, and well-organized work environment
Operates, cleans, and maintains equipment such as oligonucleotide synthesizers, purification systems, lyophilizers, and analytical instrumentation
Records activities in logbooks, forms, and batch documentation
Executes manufacturing schedule to achieve manufacturing goals
Safely handles hazardous materials/waste including organic solvents, strong acids and bases
Identifies and support the troubleshooting of technical issues with the process and equipment
Provides cross-functional site support as needed, including facility maintenance, equipment maintenance and calibration, and inventory control
Provides support for equipment commissioning
Performs other tasks as necessary or assigned