Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon/Tarpeyo, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
As Analytical Development Manager you will be responsible for all aspects of Analytical Development/Quality Control (AD/QC) to progress drug substance and drug product from early development through to clinical trials and product commercialization, as well as for products already on the market. You will have oversight of the work performed at CROs and CMOs regarding design, qualification, and validation of the analytical methods, as well as Quality Control of Clinical Trial Materials and Commercial product. You will be accountable to assure development and use of appropriate analytical methods for drug substance and drug product characterization and GMP release.
The scope of this role encompasses a wide breadth of lifecycle, ranging from early-stage development, late-stage development, early commercial manufacturing, technical stewardship of commercial products, contribution to CMC content for regulatory submissions, regulatory approval and product life cycle management, including analytical technical stewardship. This role will be critical in ensuring optimized development, reduced risk profiles and ultimately accelerate the development cycle of assets, all in a virtual CMC environment.
• Masters or PhD Degree in chemistry, biochemistry, biochemical engineering, pharmacy or related fields.
• A minimum of 5-8 years’ experience in biotech/pharmaceutical industry within relevant roles.
• Expert knowledge of analytical methods/QC as part of GMP manufacturing and DS/DP stability testing.
• In depth understanding of analytical method development, qualification and validation to appropriate level for different stages of pharmaceutical drug development.
• Experience with statistical software packages for data analysis.
• Working knowledge of GMP requirements, QC testing, ICH regulations and regulatory submission contents.
• Excellent written and verbal communication skills
You need the ability to work in a fast-paced and dynamic environment with changing priorities and flexibility to support multiple development programs simultaneously. You have the ability to solve problems using innovative thinking and good decision making. You are skilled in customer relationships and collaboration/teamwork as project manager and team member. You thrive to lead innovation, change, and drive for results. You are an excellent communicator and focus on the importance of building good and professional business relationships. You are result oriented with positive can-do attitude
Reasons to join the Calliditas Team
- Calliditas is in a very exciting stage where TARPEYO has been approved by the US FDA.
- Be a part of a global leader in IgA- Nephropathy and a rapidly growing clinical-stage pharmaceutical company
- Get in on bonus and benefit programs
- Work in fast-paced small company environment
Welcome to join the Calliditas Team!