Senior Analytical Development Scientist
12 month contract+extension/conversion (on-site South SF)
We are partnering with a forefront clinical stage oncolytic biotech company aiming to target elusive frontiers and inhibit growth of cancerous bio-mechanic pathways. With multiple projects in various clinical stages, they are looking to expand their team and talent! We are looking to hire a qualified Senior Scientist who is passionate about creating an everlasting change within the oncology sector.
The Senior Analytical Development Scientist will play a crucial role as the project lead of process R&D within the CMC function. This position will oversee API research, development, and optimization processes. As well as scaling up manufacturing to support compound development and clinical programs.
Oversee daily operations and provide analytical support for API, R&D, and manufacturing processes. Contribute to drug product manufacturing and cross functional team projects.
Work on analytical; development strategies for various clinical projects. Demonstrate technical expertise in analytical instruments and act as a reference for junior colleagues regarding Analytical development functions
Review and analyze data provided from contract partners (CDMOs/CTLs), Be able to prepare and draft study protocols, analytical reports, CMC regulatory documents.
Determine appropriate analytical methods and support/manage contract laboratory counterparts to perform analytical methods development, validation, transfer to assist development and manufacturing of API and drug conjugates.
Ph.D. or M.S. in analytical chemistry, organic chemistry, or relate fields
3+ years of relevant experience within analytical development highly preferred if experience is in supporting early phase drug development.
Superb communication and interpersonal skills with ability to interact well with researchers, scientists, contractors, investors, and staff at all levels.
Extensive experience in analytical method development using instruments (HPLC, UPLC, GC, cKF). In addition to working knowledge of regulatory submission guidelines. (IND,IMPD, NDA)
High levels of organization and attention to detail with outstanding analytical, documentation, and multi-tasking skills.
Comfortable with current ICH guidelines, GMP guidelines, and similar industry practices.
Passionate about creating a difference for those who combat cancer!