Lead - API Manufacturing

Role Summary

The Lead - API Manufacturing position oversees the production of GMP oligonucleotide API in Novo Nordisk's Boulder Clinical Pilot Plant, ensuring supply and achievement of production goals. The role includes driving continuous improvement efforts, leading technical teams, and collaborating across departments to scale processes from development to manufacturing while managing safety, quality, and regulatory compliance.

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 pilot plant scale
• Author and/or review batch documentation (data capture forms, solution preparation forms, work instructions, etc.) and generate automated equipment methods
• Execute manufacturing schedule to achieve manufacturing goals
• Safely handle hazardous materials/waste including organic solvents, strong acids and bases
• Lead troubleshooting efforts for process and equipment issues; develop and implement corrective actions
• Investigate unexpected or aberrant results during production to provide suitable root cause investigation analysis
• Support the technology transfer of manufacturing processes into Phase I/II cGMP Manufacturing Facilities
• Responsible for routine communication to all levels of the organization on manufacturing activity
• Support equipment calibration and maintenance programs
• Provides training, technical mentorship, scientific guidance, and peer leadership to junior staff

Qualifications

• Bachelor's degree in Life Science, Chemistry, or Engineering with at least eight (8) years of relevant experience; a Master‚Äôs Degree in Life Science, Chemistry, or Engineering with at least six (6) years of relevant experience; or twelve (12) years of relevant experience with a High School diploma is required
• 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)
• Familiarity with the transfer and scale-up of development processes to the manufacturing scale is preferred
• Experience with new plant startup and operation is desired

Skills

• Strong written and verbal communication
• Independent and collaborative work style within cross-functional teams
• Process troubleshooting and root cause analysis
• Technical mentorship and leadership of junior staff
• Mechanical aptitude and hands-on problem solving
• Proficiency with MS Office and basic computer literacy

Education

• Bachelor's degree in Life Science, Chemistry, or Engineering (required); Master's degree (or equivalent) preferred

Additional Requirements

• Ability to sit, stand, reach, bend, climb, balance, walk, and finger; ability to lift up to 50 lbs occasionally and up to 30 lbs frequently; visual acuity for accuracy and observations