A new position is now open in our CMC development team.
Y-mAbs Therapeutics A/S (Y-mAbs) is looking for a CMC Project Manager who can contribute to our efforts in bringing our pipeline of exiting products through the clinical development phase and into commercial supply. You will work on all CMC activities associated with our development programs, and have a close collaboration with other functional groups within Y-mAbs.
A good understanding of the outsourcing process, from quotations and contract negotiations to follow-up and troubleshooting with our CMC partners is a key competence as all manufacturing is outsourced.
The ideal candidate has an entrepreneurial mindset and must be able to work with ambitious time-lines in a slim organization with a cross-functional team and close relations to both regulatory and clinical activities.
It is key that you have in depth expertise within one or more of the following areas:
- Drug development of biologics in late stage development programs
- Downstream processes within manufacturing of biologics
- Experience in working with CMO/CRO’s and international regulatory agencies like FDA and EMA
- You will manage, coordinate and drive the Chemistry, Manufacturing and Control (CMC) part of projects in early and late stage development and towards commercial launch
- Coordinate activities within drug development and quality control using external vendors
- Be responsible for writing and reviewing the technical content of the regulatory documents for IND’s, IMPD’s and other regulatory submissions
- Work with CMC senior leadership to create project schedules that are integrated across all functions and aligned with Y-mAbs’ project prioritization and strategy
- Identify and monitor critical path, utilizing Project Management tools and develop contingency plans should the project deviate from the path
- Project management of international project teams
- Enterprising mindset that seeks solution supporting the overall goal
- Keep the overall direction and momentum despite many unsolved details
- PhD or MSc in pharmaceutical sciences, engineering or biological sciences
- 5+ years of experience in biopharmaceutical/biotech industry working with CRO’s
- You are fluent in English with excellent communication skills, written and orally
- An exciting work environment where challenging assignments will come your way
- Great office location in Hørsholm including canteen and easy parking
- Competitive salary, pension and benefit package
For more details about the job or our company, please contact Sr. CMC Project Manager Tore Søderblom at +45 5388 0988. Please note that all applications must be submitted in English and will be treated confidentially.
Deadline: please apply as soon as possible as we shall start interviews in week 29.
Y-mAbs Therapeutics A/S is a Danish affiliate of Y-mAbs Therapeutics Inc., which is located in New York. Our mission is to discover, develop and deliver novel antibody therapeutics for the treatment of both pediatric and adult cancer patients.