Technical Team Lead - API Manufacturing

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 Technical Team Lead, 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 Technical Team Lead actively supports continuous improvement initiatives and identifies wherever possible improvements that reduce risk and cost to the overall operation.

 

Relationships

The Technical Team Lead, API Manufacturing reports to the Senior Manager, API Manufacturing.

 

The Technical Team Lead works with Chemical Development, Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance.

 

The Technical Team Lead, API Manufacturing acts as a delegate for 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
• 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

 

Physical Requirements

0-10% overnight travel required. 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.

 

Qualifications

• Bachelor's degree in Life Science, Chemistry, or Engineering with at least eight (8) 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 inclu