Associate Director, Analytical Development
Novo Nordisk
2 hours ago
On-site
Boulder, CO
Operations
The Associate Director, Analytical Development oversees personnel and 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 activities at CMOs. This role is a people manager and may manage up to ten scientists locally.
Responsibilities:
- Direct daily analytical lab operations, including experimental design and execution, for analytical development and development pilot plant analytical laboratories in Boulder, CO
- Lead and direct a team of up to 10 analytical development scientists
- Plan laboratory activities, including budget management, equipment procurement, resource allocation, and space planning
- Ensure analytical lab equipment is maintained and qualified per internal requirements
- Develop robust HPLC methods for highly modified oligonucleotides; design experiments for characterization, including identifying drug substance impurities via LC-MS and forced degradation studies
- Support development, transfer, and validation of analytical methods for custom phosphoramidite raw materials, drug substances, and drug products (in-house and at CMOs)
- Support analytical needs across internal departments (e.g., facilities, chemical development, amidites, bioconjugation)
- Contribute to raw material and drug substance specification limits aligned with IND/IMPD filings
- Troubleshoot analytical methods in-house and at CMOs
- Conduct laboratory work efficiently while ensuring a safe work environment
Qualifications:
- PhD in Chemistry/Biochemistry or related (5+ years), MS (7+ years), or BS (9+ years) industrial experience
- 5+ years leadership/management experience in an analytical laboratory
- Strong background in analytical method development for oligonucleotide therapeutics
- Experience with IP-RP-UHPLC and AX-HPLC using Agilent, Waters, and/or Thermo UHPLC and associated software
- In-depth knowledge of GLP/GMP in a pharmaceutical environment
- Excellent writing and communication skills; ability to work independently and with cross-functional teams
Physical requirement:
- 0–10% overnight travel required
Application instructions:
- Job posting anticipated to close on April 21, 2026; apply via the careers website (www.novonordisk-us/careers.com).
Responsibilities:
- Direct daily analytical lab operations, including experimental design and execution, for analytical development and development pilot plant analytical laboratories in Boulder, CO
- Lead and direct a team of up to 10 analytical development scientists
- Plan laboratory activities, including budget management, equipment procurement, resource allocation, and space planning
- Ensure analytical lab equipment is maintained and qualified per internal requirements
- Develop robust HPLC methods for highly modified oligonucleotides; design experiments for characterization, including identifying drug substance impurities via LC-MS and forced degradation studies
- Support development, transfer, and validation of analytical methods for custom phosphoramidite raw materials, drug substances, and drug products (in-house and at CMOs)
- Support analytical needs across internal departments (e.g., facilities, chemical development, amidites, bioconjugation)
- Contribute to raw material and drug substance specification limits aligned with IND/IMPD filings
- Troubleshoot analytical methods in-house and at CMOs
- Conduct laboratory work efficiently while ensuring a safe work environment
Qualifications:
- PhD in Chemistry/Biochemistry or related (5+ years), MS (7+ years), or BS (9+ years) industrial experience
- 5+ years leadership/management experience in an analytical laboratory
- Strong background in analytical method development for oligonucleotide therapeutics
- Experience with IP-RP-UHPLC and AX-HPLC using Agilent, Waters, and/or Thermo UHPLC and associated software
- In-depth knowledge of GLP/GMP in a pharmaceutical environment
- Excellent writing and communication skills; ability to work independently and with cross-functional teams
Physical requirement:
- 0–10% overnight travel required
Application instructions:
- Job posting anticipated to close on April 21, 2026; apply via the careers website (www.novonordisk-us/careers.com).