- ThermoFisher Scientific (San Diego, CA)
- …for storage and testing. Conducts work in compliance with safety and regulatory requirements. May provides supervisory role for junior employees. + Responsible for ... to lead multiple stability programs with moderate to high complexity within CMC . + Coordinates communication with internal customers and external vendors. +… more
- Kelly Services (Thousand Oaks, CA)
- …development. + Collaborate cross-functionally with chemistry, biology, in vivo, and CMC teams to ensure integrated data flow for decision-making. **Qualifications & ... BioPharma Finder, or vendor-specific platforms. + Familiarity with early-stage CMC analytical needs, including assay qualification. + Knowledge of bioanalytical… more
- AbbVie (South San Francisco, CA)
- …. Job Description Sr. Scientist I Cell/Molecular Biology The Development Sciences Biologics CMC Drug Substance Cell Line Development Group in South San Francisco, CA ... lab notebook. + Author detailed technical reports that support regulatory filings at all stages from IND to BLA....biology screens + Familiarity with Chemistry, Manufacturing and Controls ( CMC ) and specifically CHO cell line development for GMP… more
- Astellas Pharma (South San Francisco, CA)
- …medicinal chemistry (payload and linker synthesis), analytical development, DMPK, pharmacology, CMC , and external partners. + Contribute to the preparation of ... technical reports, patent applications, and regulatory submission documents. **Required Qualifications** + PhD. in Chemistry, Biochemistry, Bioengineering, or a… more
- BeOne Medicines (Emeryville, CA)
- …as CMC , Reg Strategy, Clinical/Non-Clinical, Quality/Manufacturing, GTS, Pharmacovigilance and Regulatory Compliance. This position will also play a key role in ... **General** **Description:** This position resides in the Global Regulatory Operations Strategy & Innovation and will interact at all levels, including BeOne's… more
- LA Care Health Plan (Los Angeles, CA)
- …and monitoring of the guidelines and protocols to ensure readiness for all regulatory audits. This position will develop, with the assistance of CSC management, a ... Seniors and People with Disabilities (SPD) and Cal MediConnect ( CMC ) plus HIF for LA Care Medi-Cal Direct program...the deficiencies. This position will be responsible for the regulatory obligations for each line of business and their… more
- Vera Therapeutics (Brisbane, CA)
- …with a strong focus on vendor selection and performance management, regulatory compliance, risk mitigation, contract oversight & management and operational ... excellence. Critical partners for these activities include CMC & Clinical Operations. This person will oversee clinical and commercial supply chains, ensuring… more
- Kelly Services (Pleasanton, CA)
- …$175,000 - $200,000 annually **Overview** This client specializes in bioanalytical and CMC analytical services. In this role you will be responsible for the ... Practice (GLP), Good Clinical Laboratory Practice (GCLP), and other applicable regulatory standards for our bioanalytical GLP lab. This role reports directly… more
- Amgen (Thousand Oaks, CA)
- …skills, including application of scientific theory + Strong experience with regulatory requirements for API/Product ( CMC for IND/NDA, GLP/GMP, ICH) ... effectively applied + Represents Drug Substance Technologies as a scientific, regulatory and technical expert both internally and externally + Evaluates, resolves… more
- Gilead Sciences, Inc. (La Verne, CA)
- …for continuous qualification of sterile production facilities. + Provides relevant CMC support for sterile products pre- and post-approval filings. + Interface ... + Works directly with international affiliates and distributors to ensure that regulatory inspections are managed in accordance with Gilead corporate guidelines and… more