Support lab operations to cultivate mammalian cells producing biologics in bench and pilot-scale bioreactors, including sterilizing, sanitizing, and operating bioreactors, preparing buffers and feeds, and maintaining and onboarding laboratory equipment. Contribute to technology development projects to innovate process development and explore personal areas of interest. Evaluate and solve challenges associated with the scale-up of processes. Analyze seed train, production, and quality data to support process understanding and technology transfer, followed by authoring development reports, process transmittals, and documentation in electronic notebooks. Participate in Technology Transfer Start-Up Teams by transferring technology via written reports and providing virtual and on-site support during clinical production campaigns. Produce various non-clinical reagents to support Regeneron’s Research and Development activities.
Compensation
Salary Range (annually)
$71,700.00 - $112,300.00
Responsibilities
Support lab operations to cultivate mammalian cells producing biologics in bench and pilot-scale bioreactors
Sterilizing, sanitizing, and operating bioreactors, preparing buffers and feeds, and maintaining and onboarding laboratory equipment
Contribute to technology development projects to innovate process development
Evaluate and solve challenges associated with the scale-up of processes
Analyze seed train, production, and quality data to support process understanding and technology transfer
Requirements
BS in Chemical Engineering or Bio-related Engineering
Nice to have: NOVA FLEX
Nice to have: Sartorius Biostat DCU Bench Top Bioreactors
Design optimized, well-characterized, and robust seed train and bioreactor processes for upstream viral vector production in suspension cell lines, suitable for future GMP clinical and commercial production
Compensation
Salary Range (annually) $95,800.00 - $156,400.00
Responsibilities
Design optimized, well-characterized, and robust seed train and bioreactor processes for upstream viral vector production in suspension cell lines, suitable for future GMP clinical and commercial production
Lead the design and execution of studies to optimize transfection, bioreactor, and scale-up parameters for viral production using multivariate design of experiment approaches
Serve as an upstream subject matter expert and lead technology transfer to clinical manufacturing for future gene therapy programs
Conduct technology development studies aimed at enhancing process understanding and improving viral vector production, including novel reagent screening and equipment evaluation, plasmid system improvements, stable producer cell line process development, and perfusion process development
Support the development of a next generation suspension lentiviral vector production process in collaboration with Regeneron Cell Medicine colleagues
Requirements
Bachelor’s degree with 6-8+ years of relevant experience
Master’s degree with 4-6+ years of relevant experience
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
The Manufacturing Associate will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific Fremont location.
Compensation
The base compensation range for this role is between $25 and $30 an hour.
Responsibilities
Execute, with oversight of qualified staff, complex unit operations including but not limited to chromatography, TFF, depth filtration, virus filtration, and buffer preparation in GMP manufacturing suites.
Maintain own training within compliance.
Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP downstream manufacturing activities.
Author/review/approve technical documents such as tech transfer protocols and reports, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
Drive the implementation of innovative automation solutions across the site in Zaragoza, leading deployment of use cases and overseeing equipment connectivity.
Responsibilities
Collaborate with automation expert for identification of opportunities and prioritization of automation efforts
Identify challenges and requirements (packaging constraints, utilities, HSE requirements, etc.)
Lead implementation of local automation initiatives and coordinate actions with local integrators
Support implementation of additional sensors and controllers on existing equipment
Ensure implementation of new standard work on line and support operators
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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