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Senior Manufacturing Technican, Drug Product

Company: Genentech, Inc.
Location: South San Francisco
Posted on: June 6, 2021

Job Description:

The manufacturing technician is responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems in a cGMP manufacturing environment. The individual will operate production equipment for our Bulk Processing, Filling/Aseptic Operations, and Inspection. This may include process monitoring, in-process sampling, bulk formulation, fill line operations, lyophilization, bulk freeze/thaw, transfer operations, final vial inspection, and equipment set up/ changeover. The individual will be required to work in and maintain a clean room environment with aseptic processing in accordance with Standard Operating Procedures (SOPs). Must maintain batch records and associated documentation to comply with regulatory requirements and current Good Manufacturing Practices (cGMP). Area of work must remain in a high state of inspection readiness at all times. ResponsibilitiesWe are seeking applicants for this position who possess the following skills and experience: Able to operate in a clean room environment by adhering to aseptic processing qualifications and requirements. Able to perform equipment set up and change over. Demonstrate ability to train others on equipment and documentation systems. Adhere to proper documentation (manufacturing tickets and standard operating procedures). Complete and review production documents in real time. Participate in on-going training programs to enhance technical proficiency. Provide basic troubleshooting guidance or production related equipment. Inspect empty vials and filled product with a focus on quality and efficiency. Communicate effectively and ability to work in a team environment. Professional interpersonal skills. Embraces principles and behaviors consistent with the needs of the business. Continuously in search of ways to maintain the highest levels of productivity. Actively participates in a team environment that maintains a high performance culture. Able to problem solve and manage projects from start through completion. Demonstrate mastery of equipment by performing troubleshooting.Qualifications Bachelor's degree preferably in Life Sciences or engineering, or Associate degree and 5+ years related experience , o r High School diploma and 5+ years related experience. Biotech certificate from approved program desirable.Understands the theory, concepts, and regulations behind biopharmaceutical technology and processes. Ability to understand high levels of automation and technical process knowledge within area of responsibility. Understand aseptic and clean room principles Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job. Must re-qualify every year on all job-related tests and certifications as job or qualifications require. Can pass a vision acuity and color discrimination test as well as routine medical screenings for conditions that could impact the manufacturing environment. Passion and drive to develop and maintain a culture dedicated to providing the best results for our internal and external customers. Excellent oral and written communication skills. Demonstrate problem solving skills. Lean production system experience desired. Detail oriented documentation skills. Physical Demands/Work Environment/Safety Considerations Schedule could include a non-rotating 3 or 4-day (12 hour shift including one weekend day), evening or night hours. Expected to be on feet for 8 to 13 hours a day. Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility. Able to lift and carry up to 40 lbs. Push and/or pull with force of 50lbs with full body, and Push/Pull force of 24lbs with arms only may be required. Working within a clean room environment requires: Gowning in the form of hospital scrubs, coveralls, gloves, and steel toe boots. No make up or jewelry can be worn when working in the cleanroom environment. Comfortable working in areas with large mechanical equipment, process piping, pumps, pressurized vessels, which can occasionally create a loud working environment. Must wear personal protective equipment in accordance with workplace hazards. Work with hazardous materials and chemicals.

Keywords: Genentech, Inc., South San Francisco , Senior Manufacturing Technican, Drug Product, Other , South San Francisco, California

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