Associate Director, Analytical Development

About the Department

The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. 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.  Together, we are driving change. Are you ready to make a difference.

 

The Position

The Associate Director, Analytical Development oversees personnel and the daily operations of the analytical development team and experimental design at the Boulder, CO laboratory, including internal non-GMP production support and oversight of analytical actvities at CMOs. This role is a people manager and may manage up to ten scientists, locally.

 

Relationships

This position reports to the Senior Director, Analytical Development.

 

Essential Functions

• Direct daily analytical lab operations, including experimental design and execution, for analytical development activities for both the analytical development and development pilot plant analytical laboratories in the Boulder, CO
• Lead and direct a team of up to 10 analytical development scientists, fostering effective collaboration, productivity, and professional growth
• Plan laboratory activities, including budget management, equipment procurement, resource allocation, and space planning
• Ensure that all analytical lab equipment is maintained and qualified in compliance with internal requirements
• Responsible for the development of robust HPLC methods for the analysis of highly modified oligonucleotides, design of unique experiments for their characterization, including identification of drug substance impurities using LC-MS and forced degradation studies
  Provide scientific support for the development, transfer, and validation of analytical methods for custom phosphoramidite raw materials, drug substances, and drug products both in-house and at contract manufacturing organizations (CMOs)
• Responsible for supporting analytical needs throughout internal departments including facilities, chemical development, amidites, bioconjugation activities and others as necessary
• Contribute to raw material and drug substance specification limits in accordance with regulatory requirements and in alignment with IND or IMPD filings
• Troubleshoot analytical methods both in-house and at CMO’s to resolve issues effectively
• Conduct laboratory work efficiently while ensuring a safe work environment

Physical Requirements

0-10% overnight travel required.

 

Development of People

Supervisory. 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

• PhD in Chemistry, Biochemistry or related field with a minimum of 5 years, MS with a minimum of 7 years, or a BS with a minimum of 9 years of industrial experience required
• Minimum of 5 years leadership/management experience in an analytical laboratory required
• Strong background in the analytical development of methods for the analysis of oligonucleotide therapeutics
• Experience with IP-RP-UHPLC and AX-HPLC analytical techniques using Agilent, Waters and/or Thermo UHPLC’s and associated software
• In depth knowledge of GLP/GMP’s in a pharmaceutical environment
• The successful candidate must possess excellent writing and communication skills and a demonstrated ability to work independently and with cross-functional teams

 

The base compensation range for this position is $170,000 to $205,000. 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. Novo Nordisk offers long-term incentive compensation and or company vehicle