Senior Analytical Project Manager
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Bagsværd • Denmark
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Job Level
About the role
- Ensuring progress, planning, and execution of analytical activities in development or LCM projects.
- Managing the department’s project portfolio and providing professional guidance and sparring to the projects regarding analytical methods incl. validation.
- Interact with a wide variety of stakeholders such as technical project managers (for e.g., drug product and drug substance), CMC, Quality Assurance, Regulatory Affairs, and representatives from Quality Control departments.
- Collaborate and coordinate with analytical professionals who are working hands-on with method validation and optimization, transfers and regulatory writing.
- Be responsible for aligning the needs of the project organization with those in line of business.
- Work closely with stakeholders across the organization regarding both planning and execution and facilitating resolving concrete scientific challenges.
Requirements
- A relevant academic degree within Pharmacy, Biology, Chemistry, Engineering or a similar field.
- Experience within analytical chemistry combined with knowledge of GMP requirements.
- Experience in managing/coordinating and executing smaller and larger projects within CMC analytical development and/or QC.
- Experience in leading analytical activities in either early phase and/or late phase clinical development.
- Scientific experience within analytical development and/or validation and preferably experience with regulatory submissions.
- Experience in transfer of analytical methods and CMO collaboration is an advantage.
- Strong communication skills both in spoken and written English.
Benefits
- Health insurance
- Opportunities to learn and develop
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
analytical chemistrymethod validationmethod optimizationregulatory writingproject managementGMP requirementsanalytical developmentregulatory submissionstransfer of analytical methodsCMC analytical development
Soft skills
communication skillsstakeholder managementcollaborationproblem-solvingguidanceplanningexecutioncoordinationleadershipinterpersonal skills