Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. As one of the world’s leading innovation companies we are a trendsetter in research intensive areas. Bayer's products and services are designed to improve quality of life. In 2014 Bayer acquired the Norwegian biotech company Algeta and further strengthened our position within innovative cancer research and development. As a result, we are investing heavily in production and R&D in Norway and increasing our ambition to provide patients with innovative and qualitative treatment. The integration of Algeta is a unique chapter in Bayer’s 50-year long Norwegian history and our greatest pride. Bayer has 160 employees in Norway and is located at Lysaker in new and attractive offices and laboratories. At Bayer you have the opportunity to be part of a culture where we value passion to innovate and give our employees the power to change.
Head of CMC Documentation Alpha-Pharmaceuticals
Bayer AS in Oslo is the center of excellence for Radiopharmaceuticals within Bayer, and focuses currently on development and lifecycle management of radio-pharmaceuticals for cancer therapy.
Major tasks and responsibilities:
The position as Head of CMC (Chemistry, Manufacturing and Controls) Documentation is becoming vacant in near future, and we are looking for a suitable candidate for replacement.
The CMC Documentation team currently consists of 3 people (incl. the Head) who work in close collaboration with our scientists to strategically plan, issue and review relevant regulatory CMC documents for clinical trial applications as well as regulatory life cycle management of our globally marketed radiopharmaceutical drug product Xofigo®.
Head of CMC Documentation and the team are responsible for giving advice on regulatory CMC strategy during development and for the compilation of the quality parts (Module 2 and 3 ) of the IND/IMPD and NDA/MAA for the radionuclides as well as the radioactive drug products.
The team is also involved in agency-related responses upon submissions and works in close collaboration with scientists from Bayer AS in Oslo, as well as close international collaboration with global Regulatory CMC, and cross-functional Technical Development Teams from Bayer’s R&D centres .
Besides the operative tasks and responsibilities the position holder will lead the CMC team as part of the local Quality and CMC Documentation Leadership team.
We are looking for a candidate with Master of Science in Pharmacy, Chemistry, Biology or equivalent.
Profound CMC regulatory knowledge as well as experience within CMC development either from pharmaceutical industry or agency is needed.
Experience with radiopharmaceuticals is beneficial, but no required.
Fluent English (both orally and in writing) is a prerequisite.
It is very positive if the candidate has leadership experience or aspirations, strong communication and inter-cultural skills as well as project management skills. In addition, collaboration and flexibility will be important.
The position will be located at Bayer AS main offices at Lysaker in Oslo, Norway. The role will report to the Head of Quality & CMC Documentation.
We can offer a positive work environment at our nice offices at Lysaker. In addition to competitive benefits we can also offer good development opportunities.
The recruitment process is carried out in collaboration with the consulting company Borka Consulting AS. If you would like to find out more about this position before submitting your application, please do not hesitate to contact Cecilie Fraas Borka, phone +47 928 55 352 or email to email@example.com
Borka Consulting is a search and recruitment company in the Life Science industries that help clients find talented candidates in all roles in the Life Science sector in Norway, The Nordics and in Europe.
To be considered for this great opportunity, please submit your application in this portal
to apply and upload your CV and motivational letter at your earliest convenience and no later than November 21st 2022.
CMC: Chemistry Manufacture and Control = Quality
IND: Investigational New Drug Application
IMPD: Investigational Medicinal Product Dossier
NDA: New Drug Application
MAA: Marketing Authorization Application