Associate Director - Process Chemistry

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 Director, Process Chemistry will be responsible for the design, development and staffing of the RNAi Chemical Development capability at Dicerna and Novo Nordisk. The incumbent will be highly experienced process chemist, preferably with experience in biocatalytic methods of synthesis, and responsible for development and scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel strategies towards highly scalable and sustainable production of small molecules and oligonucleotide products.

 

Relationships

This position reports to Senior Director, Chemical Development.

 

Essential Functions

• Lead the development, optimization, and scale up of biocatalytic and traditional synthetic processes to successfully transfer production internally or at external CMO’s
• Develop, mentor, and lead a team of process development chemists and engineers
• Oversee the efficient utilization of a kilo lab pilot facility
• Direct development and scale-up of liquid phase batch processes used to generate small molecules, oligonucleotide Intermediates, and API’s
• Analyze research data to identify and evaluate problems and determine appropriate solutions utilizing an array of analytical techniques
• Support regulatory filings as necessary
• Support the overall Chemical Development team goals with accurate budget and staff projections
• Maintain the highest level of scientific rigor and professionalism within our organization

 

Physical Requirements

0-10% overnight travel required.

 

Development of People

Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.

 

Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

 

Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

 

Qualifications

• A PhD in Chemistry, Chemical Engineering, or related sciences with 8+ years of relevant experience, or MS in Chemistry, Chemical Engineering, or related sciences with 10+ years of relevant experience
• Proven track record of experience in process chemistry with demonstrated expertise in the optimization and scale up of pharmaceutically relevant compounds
• Well versed in process scale up
• Ability to develop, mentor and lead process chemistry teams
• Tech transfer experience
• Excellent research skills; ability to identify and define problems, develop hypotheses, and develop and execute plans to solve the problem
• Outstanding written and verbal communication skills
• Strong problem solving and trouble shooting skills
• Preferred Qualifications:
  • Experience with development and characterization of biocatalytic processes
  • CMO management experience
  • A deep understanding of and ability to apply of GMP/ICH/FDA regulations to process development strategies for Oligonucleotide based drugs

 

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 ar