Sr. Manufacturing Associate, Upstream
$30 - $45 per hourBionova Scientific, Inc.
- # Sr. Manufacturing Associate, UpstreamApplyremote type: On-sitelocations: Fremont, CAtime type: Full timeposted on: Posted 5 Days Agojob requisition id: R5712## 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, CaliforniaFull 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.
- J-18808-Ljbffr Bionova Scientific, Inc.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Sr. Manufacturing Associate, Upstream in Fremont, CA vacancy
$30 - $45 per hour
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...SeniorWork at officeAfternoon shift- Bionova Scientific LLC in Fremont, CA seeks a Senior Manufacturing Associate - Upstream to independently execute complex upstream unit operations, mentor junior staff, and lead investigations. The role requires GMP qualification and strong documentation discipline. The...SeniorFull time
$25 - $30 per hour
...biologics CDMO focused on developing and manufacturing recombinant protein products using... ...team. Position Summary: The Manufacturing Associate will actively contribute to the manufacturing... ...-GMP tox material generation and GMP upstream manufacturing activities. Author/review...SuggestedFull timeTemporary workWork at officeImmediate startFlexible hours$75k - $122k
Sr Manufacturing Associate, Filling and Visual Inspection, ONSITE, Fremont CA, NIGHT SHIFT Description This role is ONSITE Night Shift: Sunday to Thursday 10pm-6:30am. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development,...SeniorWork experience placementRelocationShift workNight shift- Alamar Biosciences, Inc. is seeking a Senior Manufacturing Associate for the second shift in Fremont, CA. You will perform processing and conjugation of antibodies, lyophilization, and related manufacturing tasks in a GMP environment. The role requires a BS in Biology or...SeniorWeekend workAfternoon shift
$85k - $100k
...provided over the weekend; candidates must demonstrate extensive experience working independently and making sound decisions in a manufacturing environment. Ability to troubleshoot and resolve complex technical issues autonomously, escalating only when necessary. Provide...SeniorFull timeWork at officeImmediate startWeekend workWeekday work- Stryker Group in Fremont, CA is seeking a Senior Portfolio Manager to drive upstream marketing initiatives for Neurovascular products. This hybrid role blends strategic planning with hands-on market insight. You will gather competitive insights, develop value propositions...Senior
- Bionova Scientific, Inc. in Fremont, CA is seeking a Senior Manufacturing Associate - Upstream to independently execute complex upstream unit operations, mentor staff, and drive continuous improvement in a GMP biotech environment. The role requires hands-on experience...Senior
- Bionova Scientific LLC is seeking a Senior Manufacturing Associate - Upstream to lead complex upstream operations on the Fremont site. You will independently run media prep, thaw/expansion, and bioreactor processes, while serving as SME and trainer for junior staff. The...SeniorShift work
- Alamar is seeking a Senior Manufacturing Associate for the second shift to join our Operations team in a fast-paced biotechnology setting in Fremont, CA. You will handle antibody processing, lyophilization, and conformity with SOPs and Quality Systems. This role requires...SeniorAfternoon shift
$110k - $130k
...Description We are seeking an experienced, detailed oriented, and results-driven candidate to join our Operations team as Lead Manufacturing Associate - Lyophilization. This position act as the subject matter expert to commission new lyophilizers, train Manufacturing staff,...Full time- ...engineering challenges into production reality for technology innovators building AI, cloud, and connected infrastructure. As a US-based manufacturing partner, the company rapidly delivers fast, agile execution through dep technical partnerships and co-innovation, and supply...SeniorFull timeFlexible hours
$200k - $260k
...cards, with a strong focus on innovation, miniaturization, and manufacturing automation. Our advanced optical, mechanical, electrical, and software... ...datacenters, artificial intelligence, and supercomputing.The Sr Principal Laser Packaging Engineer will own the technical...SeniorFlexible hours$150k - $190k
...datacenter applications • Collaborate with firmware, software, optics, process engineering, product management, quality, and manufacturing teams throughout product development • Support system integration, design validation, EVT/DVT activities, NPI, and production...SeniorH1bRemote workVisa sponsorship2 days per weekThe Hiring Method, LLC
Fremont, CAa month ago$170k - $220k
...~ Hands on experience with major cloud platforms, preferably AWS. ~ Skilled in debugging complex issues and engaging with upstream open-source communities. Why Join Us? ~ Impact at Scale – Build and lead DTEX’s first sales enablement function, shaping...SeniorFull timeRemote workWorldwideDTEX Systems
Fremont, CAmore than 2 months ago- Hyve Solutions, a US-based manufacturing partner, seeks a Process Engineering support professional in Fremont. You will assist engineering programs, manage tool needs, and perform maintenance on production equipment to ensure continuous operations. Responsibilities include...
- Biolog, Inc. is hiring a Manufacturing Associate in Hayward, CA to support in-house production of consumables. You will formulate reagents, run manufacturing workflows, and package finished goods, with potential shipping duties. The role emphasizes accuracy, safety, and...
- Manufacturing Facilities & Equipment Specialist Location: Fremont, CA (100% Onsite) Employment Type: Contract-to-Hire About the Role Join an innovative advanced manufacturing company developing precision sensing technologies used across multiple industries. We are seeking...Contract workShift work
- Red Oak Technologies in Fremont, CA is seeking a hands-on Manufacturing Facilities & Equipment Specialist to maintain building infrastructure, support production tools, and ensure a safe, efficient manufacturing environment onsite. You will perform preventive and corrective...
- ..., and helping hospitals and diagnostic labs deliver better outcomes, you belong on our team. The Role Biolog is seeking a Manufacturing Associate to support in-house manufacturing of Biolog consumable products within our Operations Consumables Production team in Hayward...Temporary workWork at officeFlexible hours
- ...advanced packaging foundry partners. Coordinate and drive foundry engagements related to process development, process control, manufacturing readiness, and technology qualification. Plan, coordinate, and participate in technical and quality audits of external foundry...SeniorWork at office
- ...Job Title: Manufacturing Associate I Location: Fremont, CA Openings: 8 Positions Available Schedule ~3rd Shift: Monday-Friday, 10... ...procedures. This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly and...Work experience placementMonday to FridayShift workNight shiftAfternoon shift
- TypeDirect Placement As the Sr/Director, IT Staffing Sales, You will be responsible to Please respond to Ankita Kahar - ****@*****.***:Aggressively drive expansion of Intelliswift brand across US within existing and new clients.Oversee,...Senior
- Lead Manufacturing Associate - Lyophilization Onsite: Fremont, CA About: At a rapidly growing life sciences company, we are passionate about enabling customers to make scientific discoveries that translate into clinical outcomes and improve patient care. Our team is expanding...Work at office
- About MattsonCompany: Mattson Technology, Inc., a 38-year Silicon Valley company, designs, manufactures, markets, and globally supports plasma and rapid thermal processing equipment to fabricate integrated circuits for the global semiconductor industry.Mattson Technology...SeniorWorldwide
- ...Job Description Job Description Position: Sr. Electrical Design Engineer / Project Engineer III Location: Fremont, CA... ...specifically in power supply design, and experience with designing for manufacturing. Key Responsibilities: ~Apply a strong theoretical...Senior
PHIHONG USA
Fremont, CA12 days ago - ...Senior Financial Analyst, Manufacturing The Senior Financial Analyst, Manufacturing functions as a key finance professional primarily responsible for strategically leading financial planning and analysis of product cost, inventory, and supply chain to provide reliable...Senior
Amprius Technologies
Fremont, CA3 days ago - Jobtailor in Fremont, CA seeks a senior market and product marketing professional to drive upstream marketing, market research, and strategic launch planning for medical devices. You will lead cross-functional teams to shape value propositions, pricing, and evidence generation...Senior
- Stryker in Fremont, CA seeks a Senior Portfolio Manager to drive upstream marketing for Neurovascular products. The role blends market research, competitive insights, and cross-functional leadership to shape value propositions and product launch plans. You will build financial...Senior
- University HealthCare Alliance (dba Stanford Medicine Partners) is the medical foundation of Stanford Health Care and Stanford Medicine. Stanford Medicine Partners was born out of the aspiration for Stanford Medicine and local, leading providers to partner together to ...SeniorLocal area
Stanford Health Care - ValleyCare
Newark, CA5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Sr. Manufacturing Associate, Upstream. Be the first to apply!
Related searches
- pharmaceutical manufacturing associate Fremont, CA
- manufacturing associate Fremont, CA
- senior safety specialist Fremont, CA
- senior technology project manager Fremont, CA
- remote senior business analyst Fremont, CA
- senior manager clinical operations Fremont, CA
- senior supervisor Fremont, CA
- senior leadership Fremont, CA
- senior director engineering Fremont, CA
- senior grant accountant Fremont, CA