Sr. Manufacturing Associate, Upstream
Asahi Kasei Battery Separator Canada Corporation
Fremont, CA
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
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.
- 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.
- 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.
Posted 2026-08-08
Recommended Jobs
Senior Software Engineer - High Frequency Systems & Communications
The Marlin Alliance, Inc.
San Diego, CA
Senior Software Engineer – High Frequency Systems & Communications The Senior Software Engineer will serve in a role embedded within a DoD client laboratory environment. This position supports softwa…
View Details
Posted 2026-07-17
Investment Banking Executive Assistant - Menlo Park
Morgan Stanley
Menlo Park, CA
The Executive Assistant will be responsible for performing an array of administrative functions requiring confidentiality, initiative and sound decision making for the executive and his/her team. You…
View Details
Posted 2026-08-03
Assistant Program Financial Analyst
Catholic Charities of Santa Clara County
San Jose, CA
: POSITION SUMMARY: The Assistant Program Financial Analyst (APFA) plays a supportive role as a Fiscal partner to the program operations of the agency. As an APFA, whether it is creating invoices…
View Details
Posted 2026-08-06
Barista
Breadbelly
San Francisco, CA
Wednesday - Monday, 7:30 AM - 3:30 PM Full Time: 5 days a week Weekend available is required. Hourly wage + tips (pooled house) Job requirements: · Ability to follow and execute recipes (…
View Details
Posted 2026-08-03
Psychiatrist - Medical Director Location: San Diego, CA
ESR Healthcare
San Diego, CA
Psychiatrist - Medical Director Location: San Diego, CA Setting: Outpatient Clinic Term: 12 Months Shift Schedule: part-time Pay Rate: $2000/day Benefits of Psychiatrist: W…
View Details
Posted 2026-08-03
Part-Time RADT/RAC/CADC (Residential Technician or Certified Counselor) Weekend Shifts
Crosspointe Recovery
Los Angeles, CA
Job Description Job Description Salary: Negotiable Please only apply if you have a minimum of 1 year experience in the addiction field. Crosspointe Recovery, located in Sherman Oaks, CA i…
View Details
Posted 2026-06-26
Attendance Secretary II
Ukiah Unified School District
Ukiah, CA
: Ukiah Unified School District CLASSIFIED Equal Employment Opportunity JOB TITLE: Attendance Secretary II LEVEL: G DIVISION: School Site REPORTS TO: Site Supervisor APPROVED BY THE BOAR…
View Details
Posted 2026-08-06
Crew Member
Chipotle Mexican Grill
Redlands, CA
CULTIVATE A BETTER WORLD Food served fast does not have to be a typical fast-food experience. Chipotle has always done things differently, both in and out of our restaurants. We are changing the fac…
View Details
Posted 2026-08-09