Manager Analytical Development - 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 development and validation of methods applicable to OxThera’s product Oxabact and will be OxThera''''s project manager working with external laboratories at which the practical development work is performed, as well as the subject matter expert for the analytical methods.
- Project manager for analytical method development of characterization methods and methods suitable for release and stability testing in the commercial set up.
- Subject Matter Expert for analytical methods for Oxabact.
- Responsible for characterization strategies of Oxabact cell banks, process intermediates and drug product.
- Manages comparability studies, including writing protocols and reports, to support CMC changes.
- Assembles justifications and provide oversight of specifications and critical quality attributes.
- Provides support to method validations.
- Provides support to process and formulation development with analytical expertise and method adaption.
- Sets up bridging studies when new methods are introduced at external labs.
- Works with the analytical lab/CMOs to provide day-to-day oversight as needed.
- Provide input to regulatory filings such as INDs, IMPDs, and market applications.
Desired Education, Skills and Experience
- MSc in biochemistry, microbiology or equivalent.
- Analytical chemist (MSc) with a minimum of 7-9 years’ experience from method development for biological products in late clinical or commercial phase.
- Experience of analytical method validation for biological products for phase III and commercial production.
- Demonstrated knowledge of GMP and requirements for method validation applicable to quality control (QC) standards.
- Microbiologist with knowledge of Live Biotherapeutic Products is highly valued.
- Working knowledge of current ICH, FDA, and EMA guidelines.
- Experience with Solid Oral Dose forms is preferred.
- Experience in setting up analytical comparability studies to support manufacturing changes.
- Experience of writing analytical sections in CMC documentation for regulatory filings.
- 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 Analytical Development" 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.