Synthetic Organic Chemists Responsible for Outsourced Activities within CMC API Chemica...

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  • Research
  • Bagsværd

We are seeking two organic chemist colleagues with experience in drug substance process development or API-manufacturing to join our team of dedicated chemists, coordinating outsourced process development activities at CMOs worldwide. If you are science driven, pro-active, structured and have excellent communication skills, you are the right person for us. We can offer you a stimulating working environment in the technological forefront, where you will develop your scientific skills and regulatory understanding, in close collaboration with highly talented and motivated colleagues and with external partners.

About the department

Chemical Development consists of more than 50 employees, divided into four teams. The department contributes to the delivery of chemical APIs (Active Pharmaceutical Ingredients), e.g. synthetic peptides, oligonucleotides and small molecules, as well as the delivery of chemical intermediates for the modification of recombinant peptides and proteins. The department is involved in early non-clinical projects, up to phase 3 GMP-manufacturing, process validation and transfer to commercial production. The aim is to develop robust, technically feasible and economical processes with little environmental impact. This is enabled by new technologies being pursued internally and by external collaborations with business partners and academia.

The team, including 9 chemists, is responsible for coordination of outsourced activities. The team members support the CMOs (Contract Manufacturing Organisations) during process development and production with scientific knowledge. The team is, together with CMOs and internal stakeholders, involved in process and specification justification, quality risk assessments and setting the control strategy for the processes, as well as authoring regulatory documentation.

The job

You will participate in CMC projects as a synthetic organic chemistry and process development scientific expert. You will be included in activities such as technology transfer, review of CMO documentation and troubleshooting. You will be involved in authoring of regulatory documentation (e.g. Clinical Trials Applications (CTA) and New Drug Applications (NDA)) and setting internal standards for regulatory filing, as well as writing and compiling various internal and external documentation. Once the project reaches commercialisation, you will be involved in process validation activities in collaboration with commercial production to whom you will transfer the process to.

Qualifications

We are expanding the team with two synthetic organic chemists which may have different levels of experience. For both positions you hold a PhD or equivalent in synthetic organic chemistry. Your degree is supplemented with either 1 year of professional industrial experience or a minimum of 5 years, 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, collaboration in cross-functional project groups and stakeholder management. Knowledge of analytical development and regulatory documentation is an advantage. Your employee package will reflect your experience and competencies.

You are result-oriented and take pride in delivering on time, 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. You are fluent in written and spoken English.

Travelling

Travelling to CMOs can be expected 10-20 days per year.

Contact

For further information, please contact Hanna Cotton +45 3075 3887.

Deadline

June 8, 2020

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


Information og data

Denne ledige stilling har jobtypen "Laborant", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Bagsværd.

Jobbet er oprettet på vores service den 6.2.2020, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Laborant
  • Bagsværd
  • Mandag den 08. juni 2020
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