CMC API Coordinator within synthetic chemistry

• Research
• Bagsværd

Do you want to use your professional expertise within synthetic chemistry, drug substance process development and/or API manufacturing to drive and impact a variety of early and late stage development projects? In that case, you could be our new API Coordinator in Chemistry, Manufacturing & Control (CMC) API Development.

About the department

Your new department, CMC API Project Office, consists of 20 highly motivated employees located in Bagsværd (location for this position) and Gentofte. The department is involved in the entire portfolio of development projects moving through the clinical phases from early to late stage drug substance development and production of new synthetic or recombinant drug substance candidates. We strive to have a high level of scientific knowledge and a helpful and pleasant working environment.

The job

You will coordinate and lead all CMC API project activities through the different stages of clinical development, from Lead Candidate Selection to final regulatory approval, primarily for projects within synthetic chemistry, e.g. peptide or oligonucleotide APIs. You will coordinate process development activities performed in our laboratories or outsourced to a Contract Manufacturing Organisation (CMO) - this will typically include synthesis (e.g. by solid-phase peptide synthesis or organic synthesis), purification and drying manufacturing steps.

The CMC API activities will also include establishment of new starting materials, planning of pilot scale manufacturing, development of upscaling for full scale manufacturing, authoring of regulatory documentation (e.g. Clinical Trials Application (CTA) and New Drug Application (NDA)) as well as writing and compiling of various internal and external documentation.

As an API Coordinator you will be a member of a CMC Project Core Team and you will lead a sub-project team focused on the API Development in an engaging and motivating way. The position will also give you the opportunity to collaborate with stakeholders within CMC Development and coordinate the transfer of project activities from our research unit to CMC Development and further on to our manufacturing unit Product Supply or to a CMO.

Qualifications

You hold an M.Sc. in Chemistry, Engineering or another relevant field within pharmaceutical sciences. A Ph.D in synthetic chemistry and specific knowledge within peptide or oligonucleotide/siRNA synthesis will be a clear advantage. Your degree is supplemented with minimum 4-6 years of professional experience where you have gained in-depth knowledge of working with drug substance process development and/or API manufacturing in GxP regulated facilities as well as experience with project management.

You have a high level of energy to drive your projects and engage your colleagues. You are result-oriented and take pride in delivering on your milestones, and you motivate your colleagues with a positive, forthcoming attitude. You work independently, although it also motivates you to cooperate with colleagues and stakeholders across functions and departments. Lastly, you must have fluency in written and spoken English.

Contact

For further information, please contact Rune Severinsen +45 30 79 94 91.

Deadline

6 October 2019.

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