A new position is now open! Y-mAbs Therapeutics A/S (Ymabs) is looking for a Senior CMC Project Manager. You will primarily focus on CMC activities associated with our late stage development programs, and you work with CMC interfaces to other functional groups within Ymabs. 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.
- You will manage, coordinate and drive the CMC part of several projects in late stage development
- Coordinate development activities within drug product formulation, control strategies, process development/validation and quality control
- Be responsible for 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 company objectives and prioritization
- Identify and monitor critical paths, utilizing Project Management tools and develop contingency plans should projects deviate from the paths
We expect you to have in deep expertise within at least one of the following areas:
- Analyses and validation of analyses according to ICH guidelines
- Cell line development and up-stream processing – especially with CHO cells - either from pilot plant and/or commercial manufacturing
- Downstream processing – experience from pilot plant and/or commercial manufacturing
- Formulation development of proteins
- PhD or MSc in pharmaceutical sciences, engineering or biological sciences
- 5-10 years of experience managing CMC projects in biopharmaceutical/biotech industry
- You are fluent in English with excellent communication skills, written and orally
- You may expect to travel for 10-30 days per year
- An exciting work environment where challenging assignments will come your way
- Great office location by Rungsted Havn including canteen and easy parking
- Competitive salary package including pension and health insurance
For more details about the job or our company, please contact Torben Lund-Hansen, SVP, Head of Technical Operations, at +45 25403010. Please note that all applications must be submitted in English and will be treated confidentially.
Deadline: apply as soon as possible as we shall start interviews in week 11.
Apply, please use the button below.
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.