Manager, Drug Product Support and Analytics to OxThera - Stockholm
OxThera develops biopharmaceuticals based on live microbiota and biomolecules. The company has long experience in the development of orally delivered biological drugs.
OxThera is a Stockholm-based privately-held biopharmaceutical company with products in late stage clinical development focusing on Primary and Secondary Hyperoxaluria. OxThera’s intellectual property includes worldwide patents for compositions and treatment of hyperoxaluria with bacteria and enzymes. Oxabact® holds Orphan Drug designations in Europe and in the US for treatment of primary hyperoxaluria. Drug projects are in late stages and close to the market place with a very strong IP portfolio.
Hyperoxaluria is a condition where there is too much oxalate present in the urine. It can be caused by inherited (genetic) disorders, intestinal disease or excess intake of oxalate-rich foods.
The Manager of Drug Product Support and Analytics supports CMC drug product development and manufacturing, as well as supporting analytical development and validation for late-stage products. The role holder will also provide input to regulatory filings such as INDs, IMPDs, and market applications.
There will be approximately 25 % travel in this position.
Key reponsibility areas
- Supports CMC drug product development and manufacturing
- Supports analytical development and validation for late-stage products
- Provides drug product expertise including formulation development, drug product process support and oversight of drug product manufacturing
- Provides technical support to manufacturing including GMP document review, process data and trending and input into technical investigations as needed
- Provides analytical support associated with characterization, method development and validation, stability, and batch release
- Provides input to regulatory filings such as INDs, IMPDs, and market applications
- Implanting and monitoring outsourcing activities with external contract laboratories
Education and experience
You will have a MS in biochemistry, biomedical engineering, pharmacy or higher and qualified experience in formulation development and manufacturing within the biotech industry. You need to be proficient in formulation development for lyophilized products and analytical method development and validation with a working knowledge of current ICH, FDA and EMA guidelines. You also need to have experience from work with CROs. Experience from work with live cell therapeutic products is an advantage.
You need to have strong communication and interpersonal skills and to be proficient in Swedish and English.
More information and application
Please call Knut Natt och Dag on +46 722 166 800 if you have any questions. Apply by e-mailing your CV and a personal letter to email@example.com as soon as possible. We are working continiuous with this recruitment project. Write "Product Support and Analytics" in the subject field.
Welcome with your application.