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The Position
The Opportunity As the Manufacturing Technical Specialist, Single-Use Technology (SUT), you are an integral member of the OSUT (Oceanside Single Use Technology) team in Oceanside. In this role, you will be a vital contributor to the successful commercialization of the facility, providing technical and operational expertise to support solutions preparation, upstream, and downstream manufacturing processes. The team will work closely with the existing staff in the Oceanside stainless steel operations as well as with South San Francisco Clinical Supply Center (CSC) and other network fleet partners. The candidate will engage with customer groups, network teams and vendors seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.
Serve as a technical contact for team, customers and vendors to consult with on new technologies and troubleshooting efforts Support troubleshooting efforts on equipment, process, automation in support of release of drug substance material Initiate and lead projects that result in implementation and/or optimization of novel methods and technique, including optimizing process performance Support on the floor operations during production campaigns, validation and/or characterization studies, and Tech Transfer activities Support and maintain biologics manufacturing analytical equipment used for in-process testing Support effective partnerships within & outside of Roche; work closely with the SSF CSC for change initiatives Develop and deploy robust knowledge sharing experiences; coach and train other team members Contribute to achieving results in other organizations across the company Enhance safety of the organization through process/equipment improvements
Who you are
Experience in drug substance/bulk biologics experience and single use technology (SUT) preferred Understands and has experience working with single use technologies, commercial operational experience is preferred Understanding of current GMP requirements and regulations Extensive practical and theoretical expertise in biopharmaceutical manufacturing processes and process improvements Ability to work in fast paced dynamic work environment Possess excellent interpersonal, communication and collaboration skills Strong problem solving and critical thinking skills Self-motivated, organized and capable of multitasking
Behaviors, competencies, and qualities of the ideal applicant:
Hardworking and fast learning individual that thrives in a high paced environment Experience in clean room environment and familiarity with cGMP and ISO/FDA/EU standards is strongly preferred Ability to think critically and work both tactically and strategically Exhibit creativity in adapting to situations, develop contingency plans, and make decisions Strong quality mindset with attention to detail and a desire to deliver service excellence Ability to work effectively with others, exhibiting a professional manner and establish constructive working relationships
Qualifications / Requirements:
Possess thorough knowledge and understanding of cGMPs and familiarity with FDA guidelines Familiarity with ICH and European guidelines Demonstrate organizational, time management, delegation and leadership skills Demonstrate excellent English verbal and written communication and comprehension skills Must be able to support 24x7 operations and stand for extended periods of time Must be able to interface with computer systems to successfully operate manufacturing equipment. Experience with distributed control systems or other manufacturing automation is preferred 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 training and certifications as job or qualifications require May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility Lifting up to 25kg may be required. The cleanroom environment requires that company provided gowning is worn. This may include plant uniform, coveralls, gloves and safety shoes. Additionally, regulations prohibit makeup, jewelry, and other personal items from entering the clean room environment.
Relocation benefits are available for this posting. SE5 Manufacturing Technical Specialist: Education:
Work Experience:
5+ years experience in a GMP working environment with mAb biologics drug substance background (Cell Culture/Purification) is highly desired Understands the theory, concepts, and regulations behind biopharma technology and processes. 2-4 years with MS
The expected salary range for this position based on the primary location of California is $80,500 (min) - $115,000 (mid) - $149,500 (max). Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits SE6 Senior Manufacturing Technical Specialist: Education:
Work Experience:
The expected salary range for this position based on the primary location of California is $91,400 (min) - $130,500 (mid) - $169,700 (max). Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
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Genentech
Aug 23, 2025