CMC Manager

We are searching for a CMC Development & Innovation Manager to help innovate and develop the company’s platform technologies and liaise with contractors and partners. All work should be complying of the company’s quality management systems. 

This position would ideally suit an individual with a strong academic/ research background (PhD related to the subject matter highly desirable) and experience both in research and industry helpful. This position is part-time with the possibility of moving to full-time and would be based in Malmö, Sweden with periodic travel to London at least once per month. 

Reporting to the Director of Development this position is responsible for: 

• Managing formulation concept, design and development of gels and semi-solids 

• Contributing to overall CMC strategy 

• Contributing to non-clinical & clinical studies where CMC development and validation will be undertaken 

• Managing associated Contract Research Organisations 

• Developing new intellectual property and familiarization with developing new patent claims 

• Developing CMC regulatory documentation and supporting regulatory activities relating EMA, FDA and CE-Mark (Medical device) activities including 

-Review and formal approval of technical reports and/or batch records 

-QA and release of Medical Device 

• Work across functional teams 

• Regular reporting and liaising with fellow team members in London office 

Qualifications 

• Hold a life sciences BSc (Hons) degree, ideally postgraduate or doctoral degree preferred 

• At least 3 years experience post(doc) research and/ or industry experience 

• Ability to communicate effectively (spoken and written) in English utilising a variety of methods and to work collaboratively with regulatory authorities, internal and external companies in support of the Company’s goals 

• Analytical and structured working style; strong attention to detail

Overview

Location Malmö
Workload 40 hours/week , 100% onsite
Expected start date 2020-06-01
Expected end date 2020-11-30
Necessary languages English, Swedish
Necessary skills CMC

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