Drug Substance Development and Manufacturing Manager

Novo Nordisk • Boulder, CO

1d • $130,000 - $165,000

About The Position

This position is an experienced professional with the ability to support process establishment and manufacturing activities for Novo Nordisk’s oligonucleotide investigational product pipeline. This individual will be responsible for drug substance manufacturing and development at Commercial Manufacturing Organizations (CMO's) and Novo Nordisk internal manufacturing sites.

Requirements

• Bachelor's degree from an accredited university and 4+ years of experience required. Equivalent experience requirements for advanced degrees would be a master’s degree and 2+ years of experience, or a PhD and 0+ years of experience
• Strong background in oligonucleotide-based drug substance manufacturing process development is highly desired
• Knowledge of nucleic acids synthesis, purification, annealing techniques and/or analytical development of oligonucleotide analysis methods is highly desired
• Experience with AKTA 100 and AKTA purification systems is highly desired
• Thorough understanding of cGxP and applicable regulations, ability to interpret and apply regulations to complex issues to make risk management recommendations
• Ability to manage people and competing priorities and timelines in a fast-paced, rapid-growth environment

Responsibilities

• Support establishment and optimization activities developing scalable processes for oligonucleotides.
• Ensure process strategies developed at laboratory scale can achieve control limits and specifications intended for large scale manufacturing
• Serve as primary management & technical lead, overseeing CMO activities.
• Provide guidance for the process development life cycle and how early phase development transitions into commercial manufacturing
• Support the authoring and review of technical reports and protocols in support of cGMP activities.
• Serve as the technical expert supporting the development of process characterization protocols.
• Ensure documents are scientifically sound and conducted within timelines
• Support the technology transfer and scale up of internally & externally developed platform technologies to partner CMO’s or internal manufacturing
• Collaborate with cross functional teams for external or internal cGMP manufacturing of drug substance API.
• Communicate Novo Nordisk manufacturing decisions to CMO’s in a clear, concise, and timely manner
• Support the review and approval of cGMP batch documentation that ensures manufacturing can achieve the intended process control strategies.
• Review and approve change controls, in-process control sampling plans, and CAPA’s
• Perform risk evaluations of manufacturing processes and develop appropriate mitigation plans
• Coordinate with QA, regulatory, and analytical development to determine documentation for RNAi programs through all phases of product/process development and manufacturing
• Exercise sound judgement within broadly defined practices and policies in selecting techniques and evaluation criteria for obtaining results

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: Mid Level
• Number of Employees: 5,001-10,000 employees