Gilead Sciences, Inc.
Gilead Sciences, Inc. is hiring: Manufacturing Specialist in La Verne
Gilead Sciences, Inc., La Verne, CA, United States, 91750
* Demonstrates hands-on technical leadership of process development, technology transfer, and process operations within a phase appropriate cGMP environment.* Responsible for executing technology/process transfer from Lab to manufacturing production floor and provide technical input and support during manufacturing of drug products.* Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis.* Author or review technical documentation (development reports, process description, process flow protocols, batch records, etc)* Mentor junior team members on process operations and development strategies, experimental design and execution as well as process transfer.* Participate in cross functional initiatives,* Adhere to department budget and all training, compliance, and safety requirements.**Basic** **Qualifications:** * Strong understanding of biologics/sterile injectable product manufacturing processes e.g., bulk freeze/thaw, mixing/pooling, filtration, filling and/or lyophilization* Experience supporting drug product manufacturing operations, technology transfer, and/or development. Prior experience with commercial manufacturing and/or process validation is highly desirable.* Hands-on experience with process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, formulation development and technical transfer.* Broad understanding of downstream development and scale up including process transfers for new product introduction into the production lines.* Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.* Working knowledge of cGMPs and regulatory requirements of biopharmaceutical manufacturing* Experience in cleaning process design, verification, and cross contamination strategies.* Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills
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