Director of Analytical Development
Vor 3 Tagen
At Kodiak Sciences, we are seeking a highly skilled and experienced DIRECTOR OF ANALYTICAL DEVELOPMENT to join our team in Visp, Switzerland. As a key member of our Process Analytics department, you will play a vital role in ensuring the quality and reliability of our analytical methods.
About the Role:
The successful candidate will oversee the development, transfer, and validation of HPLC test methods, as well as provide support for non-HPLC related analytical test methods. You will also be responsible for establishing effective working relationships within our Biologics CMC team and with other Kodiak functions.
Key Responsibilities:
* Develop and implement efficient analytical methodologies for the release and stability testing of monoclonal antibodies, fusion proteins, and bioconjugates.
* Collaborate with internal stakeholders to ensure seamless integration of analytical activities into the overall product development process.
* Establish and maintain strong relationships with external partners, including Contract Manufacturing Organizations (CMOs), to ensure timely delivery of high-quality analytical services.
* Provide regulatory expertise and contribute to the content of regulatory documents, including INDs, IMPDs, briefing packages, and BLAs.
Requirements:
* Master or Ph.D. in a relevant area, such as Biochemistry, Biotechnology, or Biological Sciences, with 5-10 years of industrial analytical development and/or quality control experience.
* Strong knowledge of HPLC techniques and experience in managing outsourced analytical activities at CMOs.
* Excellent communication and interpersonal skills, with the ability to effectively interact with all levels of the organization.
* Fluency in English and German is required.
What We Offer:
* A competitive salary of approximately CHF 120,000 - 150,000 per annum, depending on experience.
* A dynamic and collaborative work environment with opportunities for professional growth and development.
* The chance to work on cutting-edge projects in the field of biopharmaceuticals and make a meaningful contribution to the success of Kodiak Sciences.
How to Apply:
We encourage interested candidates to submit their applications, including a cover letter and CV, through our online portal.
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