The posting
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
Company:
Bionova Scientific LLC
Job Description:
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
- 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.
- Coordinates material and consumable needs, equipment readiness, and scheduling with Manufacturing Supervisors/Leads to support production schedules.
- Maintains own GMP training compliance and acts as a resource for interpreting and clarifying SOPs and cGMP/cGDP requirements for the team.
- Maintains cleanroom standards, aseptic technique, and housekeeping in accordance with site SOPs; models and reinforces GMP behaviors on the floor.
- Performs other duties as assigned to ensure appropriate manufacturing and compounding practices.
Working Conditions
- This position works in a cleanroom/manufacturing and office environment. The role requires walking, standing, stooping, kneeling, bending, and crouching for extended periods.
- 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.
- Flexibility with work hours to meet production schedules, including evenings, weekends, and holidays, as business needs require.
Qualifications
- 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.
- 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.
- Experience authoring and/or executing batch records, SOPs, and technical protocols in a regulated environment.
- 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
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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As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
