Hiring: Sr. Manufacturing Associate, Upstream Company: Bionova Scientific Location: Fremont, CA Job Posted Time: 2026-09-10 10:23:45 Employment Type: Full-time Target Skills & Keywords : Agile, tox About the job Experience: •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. •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. Required Skills: •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. •Serves as a qualified trainer and GMP floor SME; trains, mentors, and evaluates competency of Manufacturing Associates on unit operations, equipment, and documentation practices. •Leads or provides significant technical support for equipment troubleshooting, deviation investigations, root cause analysis, and CAPA implementation on the manufacturing floor. •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. •Supports non-GMP pilot-scale and tox material generation campaigns as needed to support process development and client timelines. •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. •Assesses the impact of issues, deviations, and non-conformities on product quality, safety, efficacy, and project milestones; escalates appropriately and drives resolution. •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. Qualifications: •Demonstrated hands-on experience with single-use and/or stainless-steel bioreactor operations (e.g., seed train, production bioreactors) in a GMP environment. •Strong working knowledge of mammalian cell culture principles, upstream process performance, and troubleshooting. •Solid understanding of cGMP and cGDP requirements as they apply to manufacturing documentation, deviations, and change control; prior experience supporting audits preferred. •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. •Demonstrated experience training or mentoring junior staff or acting as an SME/back-up lead on the manufacturing floor. •Strong root-cause and investigational skills; experience authoring deviations, CAPAs, or change controls preferred. •Excellent organizational and analytical skills, with the ability to manage multiple priorities and maintain attention to detail in a fast-paced, dynamic CDMO environment. •Strong written and verbal communication skills; ability to work effectively both independently and as part of cross-functional teams. •Continuous-improvement mindset, with a track record of identifying and implementing more efficient methods, tools, or workflows. Compensation: •Actual compensation may vary depending on experience, qualifications, and internal equity Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!