Manager, Process Support and Manufacturing 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 Process Support and Manufacturing supports CMC manufacturing with an emphasis on CMO oversight, process validation and process transfer, as well as support process transfer of current manufacturing processes to alternate CMOs. 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 manufacturing with an emphasis on CMO oversight, process validation and process transfer
- Provides technical support to manufacturing including GMP document review and trending, review and input into technical investigations and process validation
- Works with the CMOs to provide day-to-day oversight and to act as a person-in-plant as needed during manufacturing campaigns
- Support process transfer of current manufacturing processes to alternate CMOs
- Provide input to regulatory filings such as INDs, IMPDs, and market applications
Education and experience
You will have a MS in biochemistry, biomedical engineering, pharmacy or higher and qualified experience in process development and manufacturing within the biotech industry. You need to be proficient in microbial frementation and lyophilisation process development and manufacturing with a working knowledge of current ICH, FDA and EMA guidelines. You also need to have experience from work with CROs. Experience with cell banking and anaerobic fermentation 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 firstname.lastname@example.org as soon as possible. We are working continiuous with this recruitment project. Write "Process Support and Manufacturing" in the subject field.
Welcome with your application.