Senior Analytical Development Manager

Novo Nordisk • Boulder, CO

2d

About The Position

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 Senior Analytical Development Manager plans and oversees analytical method validation and characterization studies for late-stage oligonucleotide assets and authors/reviews relevant sections of regulatory submissions. Relationships This position reports to the Director, Analytical Development.

Requirements

• Bachelor's degree from an accredited university and 7+ years of experience required. Equivalent experience requirements for advanced degrees would be a Master's degree and 5+ years of experience, or a PhD and 3+ years of experience
• Strong background in the analytical development and validation of methods for the analysis of oligonucleotide therapeutics
• Experience with IP-RP-UHPLC and AX-HPLC analytical techniques
• 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

Responsibilities

• Responsible for the oversight of development, transfer, and validation of analytical methods for custom phosphoramidite raw materials, oligonucleotide drug substances, and drug products at contract manufacturing organizations (CMOs) ensuring compliance with applicable ICH guidelines
• Establish and justify raw material, drug substance, and drug substance specification limits in alignment with regulatory requirements and IND/IMPD filings
• Design analytical characterization and comparability studies, including e.g., LC-MS characterization, forced degradation studies, diastereomer analysis to support changes to manufacturing, container closure, etc. in late-stage oligonucleotide development
• Actively contribute to the establishment of drug substance and drug product control strategies, ensuring that appropriate analytical methods are in place to support these strategies
• Troubleshoot analytical methods at CMO’s to resolve issues effectively
• Author and/or review relevant IND/IMPD and NDA/MAA Module 3 sections, ensuring accuracy and compliance with applicable regulatory standards
• Collaborate effectively with cross-functional teams, including analytical, manufacturing, chemical development, program management, and CMC regulatory

Benefits

• 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 vehicles depending on the position's level or other company factors.
• Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance.
• The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees