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Summary

Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in a cGMP manufacturing environment and maintaining areas in a 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 applying expert knowledge of mechanical scientific principles, processes, and biopharmaceutical processing equipment.

This position is located on-site in Oceanside, California.

Shift: 6:00 pm to 7:00 am, Wednesday through Friday, plus every other Saturday

Job Responsibilities

Essential

• Represent the department on cross-functional project teams.
• Coordinate with technology, Facilities, Engineering, and EHS to optimize equipment performance.
• Process monitoring and trending across all shifts.
• Expert in business support systems (BPCS, POMS, CIM21) and facility systems (water, CIP).
• Collect, interpret, and communicate process metrics; utilize metrics to recommend improvements.
• Possess thorough knowledge of biopharma technology, processes, and the underlying scientific concepts.
• Must demonstrate a comprehensive understanding of both general and specific aspects of multiple manufacturing departments.
• Troubleshoot and investigate complex problems and work with others to implement solutions.
• 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).
• Troubleshoot 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 have the ability to work in a team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisors 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.

Supplementary Responsibilities

• Operate bioreactors, centrifuges, other harvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate large scale UF/DF and Freeze Thaw Systems.
• Operate small-scale cell culture areas and systems by operating cleaning, setting up, and maintaining 20L batch feed bioreactors; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
• Perform Solution Preparation activities (media and buffer make-up).
• Clean, assemble, and sterilize equipment using glass washers and autoclaves.
• Perform automated CIP and SIP of fixed equipment.

Who You Are (Required)

Required Education and experience

• You meet one of the following criteria:
• Bachelor's degree in Life Sciences or Engineering ( or Similar field) and five years experience,
• Or Associate degree and seven years of experience,
• Or High school or equivalent and nine years of experience.
• or/and a Biotech certificate from an approved program.

Knowledge, Skills, and Abilities

• functions and management regarding resolving investigations and theory.Excellent oral and written communication skills demonstrated by communicating with other
• Ability to lead department and/or cross-functional meetings or project

Work Environment/Physical Demands/Safety Considerations

• 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 makeup or jewelry can be worn when working in the clean room environment.
• May work with hazardous materials and chemicals.

Relocation benefits are not available for this job posting.

The expected salary range for this position, based on the primary location for this position in California, is $25.00 - $47.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.