Analytical Project Manager

Category: Manufacturing

Location:Hillerød, Capital Region of Denmark, DK

• 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.

• 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.