Specialist- API Manufacturing

Novo Nordisk•Boulder, CO

6d•$81,000 - $140,000

About The Position

The Specialist, API Manufacturing works in Novo Nordisk's Boulder, Colorado manufacturing facilities and is responsible for the production oligonucleotide API to support toxicology studies or clinical trials. In addition to ensuring the supply of API and meeting production goals, the Specialist actively supports continuous improvement initiatives and identifies wherever possible improvements that reduce risk and cost to the overall operation.

Requirements

Bachelor's degree in Life Science, Chemistry, or Engineering with at least four (4) years of relevant experience or eight (8) years of relevant experience with a High School diploma
Strong background in oligonucleotide-based drug substance development and manufacturing including knowledge of nucleic acid synthesis, purification, ultrafiltration, annealing and lyophilization techniques and equipment is highly desired
Requires a proficient understanding of cGXP and applicable regulations and guidelines
Working knowledge of control software for automated oligonucleotide synthesizers and/or chromatography systems is highly desired
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, but not limited the use of MS Office suite programs (Word, Excel, Outlook)

Nice To Haves

Experience using NN software systems (SCADA, SAP, LIMS, Veeva) is preferred
Experience with new plant start-up and operation is desired
Familiarity with the transfer and scale-up of development processes to the manufacturing scale is preferred

Responsibilities

Responsible for the manufacture of oligonucleotide API ensuring compliance to cGXP, safety, regulatory, and business processes and/or procedures
Commission, operate, maintain, and troubleshoot pilot plant equipment such as oligonucleotide synthesizers, purification systems, lyophilizers, and analytical instrumentation
In collaboration with Chemical Development, transfer and scale-up processes from laboratory to manufacturing scale
Author and/or review batch documentation, operational procedures, forms, and other required documents.
Generate automated equipment methods
Maintains a clean, safe, and well-organized work environment
Execute manufacturing schedule to achieve manufacturing goals
Safely handle hazardous materials/waste including organic solvents, strong acids and bases
Identify and troubleshoot technical issues with the process and equipment
Investigate unexpected or aberrant results during production to provide suitable root cause investigation analysis
Responsible for routine communication to all levels of the organization on manufacturing activity
Provides cross-functional site support as needed, including facility maintenance, equipment maintenance and calibration, and inventory control.
Support equipment calibration and maintenance programs
Provides training to other staff members
Perform other tasks as necessary or assigned

Benefits

medical, dental and vision coverage
life insurance
disability insurance
401(k) savings plan
flexible spending accounts
employee assistance program
tuition reimbursement program
voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
sick time policy
flex-able vacation policy
parental leave policy