- Curia (Camarillo, CA)
- …in Quality Operations in the pharmaceutical (sterile product manufacture)/ Biologics /medical devices industry, including project, technical, and personnel management. ... + Must possess effective communication skills to collaborate with others and proactively resolve obstacles. Pay Range $179,000 - $224,320 Education, experience, location and tenure may be considered along with internal equity when job offers are extended. We… more
- Fujifilm (Sacramento, CA)
- …science, fore to our manufacturing process and facilities, in our therapies and biologics , and central to the accomplishments we help make possible for our ... customers. It's the Genki inside FUJIFILM that unites us across sites, energizes our work together forward, and pushes us toward our shared purpose of advancing tomorrow's medicines, together. The Executive Director Commercial Development Advanced Therapies… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs, and CMC technical areas ... of at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, PharmD, or MD. + Demonstrated track record of defining innovative global CMC regulatory strategies applied across a portfolio of projects. + Experience with clinical submissions at all phases of… more
- Bristol Myers Squibb (Los Angeles, CA)
- …is strongly preferred + Prior people management experience preferred + Biologics /buy and bill and specialty medications/specialty pharmacy experience preferred + ... Proven leadership skills and ability to network across complex internal and external environments + Demonstrates critical thinking and strong decision-making skills + Excellent social, communication (oral and written) and presentation skills required + Ability… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …platform), and quantitative molecular assays + Familiarity with impurity testing for biologics or gene therapies (eg, HCP assays, residual DNA/RNA, enzyme activity) ... + Proven experience developing and validating analytical methods in alignment with ICH Q2(R2), USP, and EU guidelines + Working knowledge of compendial methods and regulatory standards (USP <85>, <61/62>, <1132>, etc.) + Proficiency in data analysis using… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …Job Duties:_** + Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals. + Strict adherence to ... procedures and practices according to FDA regulations. + Strong emphasis on documentation according to FDA regulations. + Adhere to departmental corporate safety policies. + Responsible for facility and equipment cleaning. + All work is performed in a clean… more
- Abbott (Alameda, CA)
- …Degree required.** Knowledge of regulations and standards (GCP) affecting IVDs and Biologics required. Minimum 6 years' experience in a clinical research environment ... or a research laboratory with automated IVD assay/instrument experience, including data analysis. Experience with contracts and knowledge of electronic document management systems (eg APLM, SBM and other databases) desired. The base pay for this position is… more
- Grifols Shared Services North America, Inc (City Of Industry, CA)
- …Associates Degree or Bachelors degree preferred. Manufacturing, or experience in pharmaceuticals/ biologics processing in a GMP environment is preferred. + 0 - ... 1 years' experience in a manufacturing or packaging environment preferred. FDA regulated environment experience preferred. + English fluency both verbal and written. + Basic math skills with proficiency in metric system. + Accurate documentation skills is a… more
- IQVIA (San Francisco, CA)
- …integrative product development strategies for pharmaceutical products, including drugs, biologics , and devices. This role will focus on clinical-commercial ... convergence and will encompass all phases of development from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability of success for candidate… more
- Abbott (Alameda, CA)
- …years' experience working with Class II, Class III medical devices and/or biologics /drugs. Regulatory Affairs Certification (RAC) is a plus. . Experience with 510(k) ... applications, PMA supplements, US device regulations, and/ or with EU and other international medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical… more