Manager Drug Product Process Support and Manufacturing - OxThera - Stockholm
Do you want to devote yourself taking part in the work developing new drugs for patients with severe kidney disease with no cure today? You will work with development of a treatment for a disease that particularly strike children.
You will be responsible for supporting drug product manufacturing of OxThera’s product Oxabact, with an emphasis on CMO oversight during regular GMP production. You will also be the project manager and subject matter expert for the drug product process during process characterization and process validation.
- Supports CMC manufacturing with an emphasis on Drug Product and Finished Goods (Packaging and labelling) CMO oversight, process characterization, 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.
- Subject Matter Expert for Drug Product and Finished Goods manufacturing processes.
- Supports evaluation and procurement of equipment.
- 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.
Desired Education, Experience and Skills
- MSc in biochemistry or biomedical engineering
- Minimum of 7-9 years experience in Drug Product process development and manufacturing within the biotech industry
- Proficient in Drug Product and Finished Goods development and manufacturing
- Experience with Solid Oral Dose product process development and validation is preferred.
- Working knowledge of current ICH, FDA and EMA guidelines
- Experience in working with CMOs
- Strong communication and interpersonal skills
- Proficient in Swedish and English
Application and more information
Please call Knut Natt och Dag on +46 722 16 68 00 if you have any questions. You are welcome with your application to by e-mailing your CV and personal letter to email@example.com as soon as possible. We are working continuously with this recruitment project and would like to receive your application as soon as possible. Write "Manager Drug Product Process Support and Manufacturing" in the subject field.
OxThera is cooperating with Aktivia Science Work in this recruitment. Aktivia Science Work is a recruiting and consulting company within Life Sciences specialized in positions within the pharmaceutical industry - from early discovery pharmaceutical development and clinical development to the market place. We are members of SwedenBIO.