Associate - API Manufacturing

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Job description

About the Department

The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the hub for all manufacturing-related activities for GalXC and GalXC-Plus investigational therapeutics developed from Novo Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, 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. Ranked the No. 1 Place to Live for the second consecutive year by U.S. News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the world's leading centers for oligonucleotide innovation and manufacturing. 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 Pilot Plant and is responsible for the production of non-cGMP oligonucleotide API to support toxicology studies. 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 toxicology batches ensuring compliance to cGXP, safety, regulatory, and business processes and/or procedures

Operates, cleans, and maintains non-cGMP pilot plant 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 supports the troubleshooting of technical issues with the process and equipment

Supports equipment calibration and maintenance programs

Provides support for equipment commissioning

Performs other tasks as necessary or assigned

Physical Requirements

Ability to sit, stand, reach, bend, climb, balance, walk, and finger. Ability to lift up to 50lbs of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Visual acuity to determine accuracy, neatness, and thoroughness of work and to make general observations.

Travel Requirements

0-10% overnight travel required.

Development of People

Individual Contributor.

Qualifications

Bachelor's degree in Life Science, Chemistry, or Engineering or a minimum of four (4) years of related experience with a HS Diploma

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)

The base compensation range for this position is $65,000 to $95,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

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.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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