Lead upstream late-stage development activities, focusing on process characterization, down-scale model qualification, and scientific data analysis for mammalian cell culture processes.
Locations (2)
Copenhagen, Capital Region, Denmark
Søborg, Capital Region, Denmark
Responsibilities
Plan and lead process characterization studies
Design and evaluate down-scale model qualification studies
Apply statistical methods and tools such as JMP
Contribute to FMECA and process risk assessments
Support late-stage development activities including LIVCA, WCB, scale-up, and technology transfer
Requirements
Bachelor's, Master's, or PhD in biotechnology, biochemical engineering, or related discipline
Global Manufacturing Technology (GMT) is seeking a hands‑on, postdoctoral‑level scientist to improve the potency and yield of a Mycoplasma fermentation process.
Responsibilities
Plan and lead upstream studies to improve Mycoplasma fermentation performance, with emphasis on product potency and process yield.
Design and execute bench‑scale fermentation experiments; evaluate relevant process variables and use structured experimental approaches to identify key drivers of performance.
Operate and troubleshoot laboratory bioreactors and maintain appropriate aseptic technique and process documentation.
Characterize fermentation outcomes using appropriate growth, process, yield, and potency measurements; analyze results and communicate clear recommendations.
Optimize and assess downstream recovery steps, including depth filtration and chromatography, and understand how upstream conditions affect downstream performance and product quality.
Requirements
PhD in microbiology, biotechnology, biochemistry, biological engineering, chemical engineering, or a related discipline; candidates with a master’s degree and 5+ years of directly relevant experience may also be considered.
Plan and lead upstream studies to improve Mycoplasma fermentation performance, with emphasis on product potency and process yield.
Design and execute bench-scale fermentation experiments; evaluate relevant process variables and use structured experimental approaches to identify key drivers of performance.
Operate and troubleshoot laboratory bioreactors and maintain appropriate aseptic technique and process documentation.
Characterize fermentation outcomes using appropriate growth, process, yield, and potency measurements; analyze results and communicate clear recommendations.
Optimize and assess downstream recovery steps, including depth filtration and chromatography, and understand how upstream conditions affect downstream performance and product quality.
Requirements
PhD
Master's degree
Nice to have: Postdoctoral research experience
Nice to have: Mycoplasma cultivation or fermentation
The role involves helping the successful production of high-quality Gene Therapy products by overseeing upstream process execution, cell culture, and bioreactor operations.
Compensation
$124,000.00-161,000.00 Annual
Responsibilities
Execute upstream processes including cell culture expansion and bioreactor operations
Maintain GLP-compliant documentation
Operate and maintain cell culture equipment
Author records records and procedures
Contribute to continuous improvement initiatives within viral vector manufacturing
Requirements
Bachelor’s degree in Biology
Bachelor’s degree in Chemical Engineering
Bachelor’s degree in Biochemistry
Nice to have: Experience conducting manufacturing investigations in biologics or cell culture based production
The Manufacturing Associate will actively contribute to the manufacturing projects at the Bionova Scientific West Warren site, supporting GMP and manufacturing activities in a GMP multi-product facility.
Locations (2)
Fremont, California, United States
West Warren, Ohio, United States
Compensation
Compensation Range: The base compensation range for this role is between $25 and $30 an hour. However, the actual compensation may vary depending on your experience and qualifications.
Responsibilities
Executes complex unit operations including media prep, cell culture thaw, expansion, and end of production banking; operates single-use bioreactors, monitors process and harvest operations
Performs internal support activities such as maintenance of analytical equipment, stocking of consumables, discarding expired reagents, material coordination and weigh and dispense
Maintains own training within compliance and trains other GMP associates upon completion of trainer qualification
Supports equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP upstream manufacturing activities
Integral part of process development, accelerating product candidates into the clinic and gaining knowledge and experience in cell culture, purification and critical support activities.
Compensation
The annual base pay (or hourly rate of compensation) for this position ranges from $65,081.60 - $97,622.40 USD Annual.
Responsibilities
Operates bio-pharmaceutical manufacturing equipment such as incubators, stainless steel and disposable bioreactors, depth filtration skids, chromatography skids, single-use mixers, centrifuges, washers, autoclaves, tanks and in-process testing instruments.
Performs steam sterilization, clean in place, manual cleaning and sanitization of equipment
Records manufacturing activities clearly and accurately within approved current good manufacturing practices (cGMP) documents and regulatory requirements.
Prepares for processing by ensuring equipment and materials necessary are adequate and available.
Ensures a safe and environmentally sustainable work environment in accordance with AstraZeneca standards
Support clinical biomanufacturing operations for novel biologics, performing cell culture, purification, and process support activities in a cGMP environment.
Compensation
The annual base pay (or hourly rate of compensation) for this position ranges from $65,081.60 - $97,622.40 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Responsibilities
Operate bio-pharmaceutical manufacturing equipment such as incubators, bioreactors, filtration skids, chromatography skids, mixers, centrifuges, washers, autoclaves, tanks and in-process testing instruments
Perform steam sterilization, clean in place, manual cleaning and sanitization of equipment
Record manufacturing activities within cGMP documents and regulatory requirements
Prepare for processing by ensuring equipment and materials are adequate and available
Ensure a safe and environmentally sustainable work environment in accordance with AstraZeneca standards
Responsible for the cGMP manufacture of viral vector therapies for use in clinical trials and commercial launch. Includes set-up, operation, and cleaning of equipment, process monitoring, troubleshooting, and ordering materials.
Compensation
The expected salary range for this position is $85,000 to $113,000.
Responsibilities
Follow safe, compliant, and Right First-Time manufacturing operations procedures
Produce clinical/commercial material compliant with cGMPs
Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs
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