CMC Director - Göteborg - Avslutad
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Albireo is a biopharmaceutical company focused on the development and commercialization of novel bile acid modulators to treat liver diseases where there is high unmet medical need, such as rare cholestatic diseases and nonalcoholic steatohepatitis (NASH), and debilitating gastrointestinal disorders. Our clinical pipeline includes three phase 2 or later-stage product candidates that are designed to act locally to restore normal bile acid levels and treat diseases and disorders associated with irregularities in bile acid biology.
Learn more about Albireo on www.albireopharma.com.
Albireo is recruiting a CMC Director. In this role you will be is responsible for that adequate drug formulations are available to start of all clinical studies within Albireo and secure that Albireo have satisfactory CMC data set for application of clinical studies and get an approval by authority.
Accountabilities and Responsibilities
The role is to coordinate and execute all CMC tasks in Albireo
- Secure that sufficient API of adequate quality is available to start preclinical safety and clinical programs within new projects without delay the program
- Secure that sufficient drug product is available to start all clinical trials within Albireo without delay the program
- Have regular interactions with CRO and CMO to follow up progress in the projects
- Have contact with licensee companies for CMC issues
- Provide operational CMC input and guidance on the development plans
- Identify potential CMC risks to the operational plans and propose options to mitigate risks
- Prepare and manage regulatory CMC documentation
- Develop a strong CMC IP position
Experience and Skills
- University Degree in Science or related discipline, preferable a PhD Degree
- More than ten years experiences of working with CMC in a leading position in the pharmaceutical or biotech industry
- Should preferable have experience from API and/or drug product production in pilot scale
- Have worked strategically with building a strong CMC IP position within the pharma business
- Strong ability in flexibility and to work collaboratively
MORE INFORMATION AND APPLICATION
Albireo Pharmaceuticals is cooperating with the recruitment agency Aktivia Science Work in this recruitment project. If you have any questions please call Knut Natt och Dag on +46 722 166 800 or Rolf Mayer on +46 708 876 005. Send your application to email@example.com as soon as possible due to our ongoing work with this recruitment. Please write “CMC” in the subject field.
Aktivia Science Work AB is a recruitment and consultancy company within Life Science specialized in positions within the pharmaceutical industry. We have offices in Stockholm and in Lund and are part of Karolinska Institute Science Park in Stockholm and the Life Science centre in Lund. We are members in SwedenBIO and Medicon Valley Alliance. You can read more about us on our website, www.aktivia.se.