The Senior Manufacturing Associate - Upstream is an experienced, GMP-qualified contributor within the Cell Culture/Manufacturing group at the Bionova Scientific Fremont site. This role independently executes complex upstream unit operations, serves as a subject matter expert (SME) and trainer for junior staff, and takes a leading role in troubleshooting, investigations, and continuous improvement initiatives. The Senior Manufacturing Associate is expected to work with minimal oversight, exercise sound technical judgment, and support the Manufacturing Supervisor/Lead in day-to-day floor operations, scheduling, and cross-functional coordination.
Location - Fremont, California
Full time
Essential Duties and Responsibilities
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Independently executes and oversees complex upstream unit operations, including media/solution preparation, cell culture thaw and expansion, single-use and stainless-steel bioreactor operation, in-process sampling, process monitoring, and harvest with minimal supervision.
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Serves as a qualified trainer and GMP floor SME; trains, mentors, and evaluates competency of Manufacturing Associates on unit operations, equipment, and documentation practices.
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Leads or provides significant technical support for equipment troubleshooting, deviation investigations, root cause analysis, and CAPA implementation on the manufacturing floor.
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Authors, reviews, and approves GMP documentation, including batch records, SOPs, technical protocols/reports, risk assessments, and training materials; performs peer/QA-facing review of executed batch records for accuracy and compliance.
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Supports non-GMP pilot-scale and tox material generation campaigns as needed to support process development and client timelines.
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Evaluates and recommends new technologies, equipment, and process improvements to enhance operational efficiency, capacity, and cell culture capability; leads or contributes to continuous improvement/Lean initiatives.
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Assesses the impact of issues, deviations, and non-conformities on product quality, safety, efficacy, and project milestones; escalates appropriately and drives resolution.
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Contributes to quality system activities, including authoring/leading deviations, CAPAs, and change controls, and participating in internal and client/regulatory audit readiness and walk-throughs.
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Coordinates material and consumable needs, equipment readiness, and scheduling with Manufacturing Supervisors/Leads to support production schedules.
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Maintains own GMP training compliance and acts as a resource for interpreting and clarifying SOPs and cGMP/cGDP requirements for the team.
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Maintains cleanroom standards, aseptic technique, and housekeeping in accordance with site SOPs; models and reinforces GMP behaviors on the floor.
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Performs other duties as assigned to ensure appropriate manufacturing and compounding practices.
Working Conditions
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This position works in a cleanroom/manufacturing and office environment. The role requires walking, standing, stooping, kneeling, bending, and crouching for extended periods.
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Must be able to meet requirement of wearing PPE and work within a controlled/cleanroom environment and occasionally lift and/or move up to 20-25 pounds independently.
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Flexibility with work hours to meet production schedules, including evenings, weekends, and holidays, as business needs require.
Qualifications
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Bachelor's degree in Life Sciences, Biotechnology, Chemical/Biochemical Engineering, or related field with 3-5 years of relevant biopharma manufacturing experience; OR Associate's degree with 5+ years of directly relevant experience; equivalent combinations of education and experience will be considered.
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Demonstrated hands-on experience with single-use and/or stainless-steel bioreactor operations (e.g., seed train, production bioreactors) in a GMP environment.
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Strong working knowledge of mammalian cell culture principles, upstream process performance, and troubleshooting.
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Solid understanding of cGMP and cGDP requirements as they apply to manufacturing documentation, deviations, and change control; prior experience supporting audits preferred.
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Experience authoring and/or executing batch records, SOPs, and technical protocols in a regulated environment.
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Proficiency with process monitoring and equipment software (e.g., UNICORN, PI Historian, DeltaV, or similar); experience with electronic batch record (eBR) and quality management system (QMS) platforms preferred.
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Demonstrated experience training or mentoring junior staff or acting as an SME/back-up lead on the manufacturing floor.
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Strong root-cause and investigational skills; experience authoring deviations, CAPAs, or change controls preferred.
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Excellent organizational and analytical skills, with the ability to manage multiple priorities and maintain attention to detail in a fast-paced, dynamic CDMO environment.
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Strong written and verbal communication skills; ability to work effectively both independently and as part of cross-functional teams.
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Continuous-improvement mindset, with a track record of identifying and implementing more efficient methods, tools, or workflows.
Compensation
The base compensation range for this role is between $30 and $45 an hour. Actual compensation may vary depending on experience, qualifications, and internal equity.
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