Bioprocess Technician/Sr. Bioprocess Technician, Downstream Manufacturing
Genentech, Inc. - Oceanside, CA

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Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

Responsible for being proficient in two or more functional areas and applies expert knowledge of mechanical, scientific principles, processes and biopharmaceutical processing equipment.Provide coaching and training on best practices and compliance to SOPs.Prepare solutions for the production process.Participate in continuous operational improvement.Provide reports to management summarizing goal unit attainment.Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.Understands the theory, concepts, and regulations behind biopharm technology and processes.A strong knowledge of at least one manufacturing department with an understanding of process impact of other areas.Anticipates potential problems and takes preventative action.Requires judgment to know when it is necessary to consult with supervisor and/or support groups.Understands how own actions impact others and uses this information in decision-making.Operate systems that clean and sterilize tanks and filtration systems.Prepare solutions for the production process.Review documentation and check all calculations (e.g. tickets, labels, equipment reading).Trouble shoot equipment and process problems.Comply with safety requirements, cGMP, SOP and manufacturing documentation.Use of automation to perform production operations.Provide support to Manufacturing to meet production demands.Operate automated systems for equipment operation.Assemble and prepare equipment for production.Exhibit detail oriented documentation skills.Communicate effectively and ability to work in a team environment.Exhibit professional interpersonal skills.Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt.Operate fermenters, centrifuges, other harvest systems and protein purifications units.Operate and clean fixed tank and filtration systems.Operate large scale column chromatography systems.Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch reefed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.Perform CIP and SIP.Who You AreDegree in Life Sciences or Engineering and 3 years experience, or Associate degree and 5 years experience, or High School and 7 years experience.Biotech certificate from approved program.Excellent oral and written communication skills.Capable of writing detailed reports and summaries.Must possess high level of automation and technical process knowledge as related to prep and process within area of responsibility.Familiarity of computer-based systems.Background in fermentation.Schedule will include a non-rotating 4-day (10 hour shift), one weekend day, evening or night hours, or full off-shift hours.Expected to be on feet for 8 to 10 hours a day.May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.Lifting up to 25lbs may be required.Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.

Also, no make up or jewelry can be worn when working in the clean room environment.May work with hazardous materials and chemicals.

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Genentech, Inc. (Genentech) is a biotechnology company that discovers, develops, manufactures and commercializes pharmaceutical products to...