What are the responsibilities and job description for the Senior Power Market Analyst position at Yes Energy?
A pharmaceutical company in California is currently seeking a new Senior Manager, CMC QC to join their growing team in San Mateo Country. In this role, the Senior Manager, CMC QC will be responsible for all CMC QC Program support for the biological programs.Responsibilities : Support the development, validation, and transfer of analytical methods used for QC testing of biologicsManage, review, and organize Release / stability, method validation / transfer data from active stability programs and generate interim stability trending assessments and reportsSupport the external contract organization activities to fulfill the GMP QC testing for release / stability and method validation / transfer needsProvide internal support to QC operations to support the development, manufacture, method validation / transfer and release / stability activities, of BiologicsEnsure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agenciesImplement and maintain quality systems to ensure the integrity and reliability of QC dataParticipate in stability programs for clinical and commercial products in accordance with ICH / FDA / EMA / USP / Ph. Eur. guidelinesPerform other duties, as neededQualifications : 3 years of experience with Analytical and QC experience in a GMP environment (Biotech and / or Pharma)Bachelor's Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science fieldExperience with a good understanding of biologics drug substance processes; encompassing the initial cell culture and production phases (upstream), as well as the subsequent purification and isolation steps to create the final drug substance (downstream)Solid analytical and problem solving skillsGreat interpersonal skillsExcellent communication skills (written and verbal)Strong attention to detailHighly organizedDesired Skills : Working experience and knowledge in a wide variety of Quality Control Stability methodologiesExperience in conducting Stability Studies per ICH GuidelinesProficient in Statistical Analysis software (Excel / JMP)#J-18808-Ljbffr
