Analytical Project Manager

at  Novo Nordisk

THE POSITION

We are looking for an Analytical Project Manager to support transfer and implementation of analytical methods to our Contract Manufacturing Organizations (CMO) for the analysis of raw materials under Good Manufacturing Practice (GMP). Your primary responsibility will be to provide remote support to external CMO QC laboratories, handling various analytical tasks within method life cycle management.

QUALIFICATIONS

To be successful in this role, you:

• Have master’s degree in chemistry, Pharmacy, Engineering, or another relevant field within the natural sciences.
• Have a minimum of five years’ experience within QC analytical method validation (e.g., HPLC, GC, KF) and have solid knowledge of analytical methods and GMP, ICH guidelines, EP/USP, and regulatory requirements.
• Are experienced in working in a GMP environment, such as a QC laboratory or support department, preferably with CMOs.
• Have a ‘Project-mindset’ and experience driving projects in a regulated industry, preferably pharma.
• Have excellent communication skills in both written and spoken English.

On a personal level, you have a problem-solving mindset and ability to handle multiple tasks and projects. You are proactive, independent, and able to set direction and drive performance. You are motivated by the opportunity to build a large network and work in a multicultural and complex environment.
And known for your interpersonal skills that enable you to create and maintain strong relations in your team and commitment from a wide scope of stakeholders

KEY RESPONSIBILITIES:

• Coordinate analytical development, validation and other analytical activities between Novo Nordisk and CMOs
• Primary contact for CMO regarding coordinating analytical activities to ensure that the CMO has needed analyses ready and implemented
• Author and edit SOPs, review protocols and reports, tech transfer plans, and other documentation.
• Support QC setup for analytical test methods and release testing for raw materials, starting materials, excipients, and intermediates from the late development phase to market.
• Prepare for and contribute to internal and external audits and inspections.
• Lead improvement projects to optimize processes in the department.

To be successful in this role, you:

• Have master’s degree in chemistry, Pharmacy, Engineering, or another relevant field within the natural sciences.
• Have a minimum of five years’ experience within QC analytical method validation (e.g., HPLC, GC, KF) and have solid knowledge of analytical methods and GMP, ICH guidelines, EP/USP, and regulatory requirements.
• Are experienced in working in a GMP environment, such as a QC laboratory or support department, preferably with CMOs.
• Have a ‘Project-mindset’ and experience driving projects in a regulated industry, preferably pharma.
• Have excellent communication skills in both written and spoken English