QC Professional in CMC Development (temporary Position) - Denmark
- Do you want to drive approval and release of Quality Control (QC) results for phase 1 to phase 2 clinical studies and analytical results for Active Pharmaceutical Ingredient (API) in-process and process development studies?
- And do you enjoy working in an open, dynamic and social atmosphere with a strong focus on deliverables and high level GMP?
- If so, you may be our new professional in Team API Analytical Support at our company.
About the Department
- The department is responsible for testing of raw materials, release samples, in-process samples and process development samples of the entire company phase 1 and phase 2 portfolios and therefore operates under GMP regulation.
- As part of our company’s R&D family, CMC Development makes a real difference for patients with chronic diseases across the world.
- We develop, manufacture and distribute drug candidates for non-clinical and clinical trials which is a complicated journey that requires about 10 years of dedicated work in CMC Development.
- CMC Development is an ambitious organisation with a strong culture.
- We always seek to solve problems, have an eye for the entire business and do our best to deliver despite any obstacles along the way.
- In this 12 month temporary position, you will mainly work with review and release of analytical results in a dedicated team consisting of 13 technicians and 2 academics.
- The team employ a wide range of technologies to generate content and purity results such as SE, ICEIF, RP, SDS-PAGE, Bio analyzer and pH measurements.
- You will be responsible for the timely approval and release of analytical results in compliance with GMP including planning of laboratory work, review of data, handling of non-conformities, change requests as well as qualification and maintenance of equipment and instruments.
- You are expected to take an active part in the daily operation of our GMP laboratories including optimisation of workflows, Standard Operating Procedure (SOP) authoring and even troubleshooting of assays if needed.
- Furthermore, your participation in cross organisational project groups, collaboration with other departments both in Quality Control and in Research Units, including troubleshooting and transfer of analytical methods, will be part of the challenge. Needless to say, extensive experience with and a profound interest in GMP is a must.
- You either bring a proven track record of relevant experience to the table from a technical position or you hold a university degree (B.Sc or equivalent) within Natural sciences with proven skills within Chemistry and/or Biochemistry combined with a minimum of 3 year relevant experience from an equivalent position.
- You are highly experienced with working in a GMP environment, including handling of change request, non-conformities and you advocate the necessity of documentation and traceability.
- As a person you are a proactive team player who is motivated by your own drive to reach your deadlines.
- You are able to handle several tasks at the same time and you never lose sight of the end goal.
- You have good communication skills and a positive mind-set, which is helpful in an ever changing project environment.
- Furthermore, a good sense of humour and a light-hearted view on life will make a good match with your new colleagues.
- Last but not least you are fluent in Danish both written and spoken.
Working with Us:
- We are an organisation with many international employees and we welcome local as well as non-local applicants.
- We offer an inspiring and ambitious working environment, alongside the flexibility that allows you to influence your own working day.
- We believe that is what stimulates the ingenuity to develop the next generations of cutting-edge treatments.
- Your skills, dedication and ambition help us change lives for the better.
- In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.