Associate, API Manufacturing
$70.4k - $82.5kFull-time
Novo Nordisk Inc.
About the Department 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. 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. Relationships The Associate - API Manufacturing reports to the Senior Manager, API Manufacturing. Essential Functions
- 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
- 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)
- Experience using NN software systems (SCADA, SAP, LIMS, Veeva) is preferred
Vacancy posted 1 day ago
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