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CMC Project Manager

Exciting CMC position within topical formulations 

 

As MC2 Therapeutics is expanding, they are looking for an experienced CMC Project Manager to support development and manufacture of topical formulations.  

The CMC Project Manager will work closely with the Senior Director CMC, COO, and R&D unit in the UK and be involved in the entire drug development process from preclinical to the clinical activities.   

With direct report to the COO.  

Your main tasks are:  

  • CMC project management related  to specific projects and/or tasks 
  • Key role in the development and characterisation of topical formulations for MC2’s preclinical and clinical programmes including manufacturing process development and control strategies. Experience with small molecues will be an advantage 
  • Day-to-day interaction with external parties as appropriate such as providing scientific input and guidance to CMOs  
  • Cooperation with R&D unit in the UK 
  • Detailed drafting, review, and archiving of CMC technical documents 
  • Support CMC tasks related to QMS 
  • Support drafting of CMC regulatory documents as relevant 

Your qualifications are 5-10 years of experience from the pharmaceutical industry within formulation development and CMC. You have experience with formulation activities, preferably within topicals and you also have experience with small molecule CMC. You possess solid knowledge of manufacturing process development and have a strong GMP understanding. Moreover, you have experience with analytical method development and manufacturing process controls as well as a general good understanding of the drug development process. You have experience with working with CMOs and strong CMC writing skills. Finally, you have excellent communication, presentation, negotiation and collaborative skills. 

You have a Master’s Degree in Pharmaceuticals or the like. 

You are a persowho is self-driven, able to take responsibility for your own projects and have a natural interest to engage directly in development details. It is crucial that you are proactive and can work independently and set the direction. You have strong collaborative skills and can create successful working relationships with both internal and external stakeholders. You have strong project management skills, and you must work in a structured way with an eye for details. You are systematic/organized and set high quality standards and you must be flexible and open to challenges.  

Travelling: 5 – 15 days per year. 

Domicile: Hørsholm, North of Copenhagen. 

For more details about the job or the company, please Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
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