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Salubris Biotherapeutics · 2 days ago
Upstream Cell Culture Process Development Scientist III
Gaithersburg, MD
Full-time
Onsite
Senior Level
10+ years exp
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Responsibilities
Lead and oversee upstream cell culture process development, optimization, and scale-up activities ranging from cell line development to large scale bioreactor production.
Design, execute, and analyze experiments using design of experiments (DOE) methodologies to optimize cell culture processes for improved productivity and product quality.
Lead process characterization studies to establish critical process parameters and ranges to support regulatory filings and required updates.
Author development and technology transfer documents to control and define process evolution through clinical stages.
Act as Upstream Cell Culture Lead to support interaction and management of contractors and vendors.
Collaborate closely with cross-functional teams including process development, downstream purification, analytical sciences, and manufacturing to ensure seamless technology transfer from lab-scale to commercial production.
Provide technical leadership and guidance on cell culture process development strategies, medium optimization troubleshooting, and process risk mitigation.
Drive innovation and continuous improvement initiatives to enhance upstream cell culture processes, including the evaluation and implementation of new technologies and platforms.
Mentor and coach junior team members, fostering their professional growth and development in upstream cell culture.
Ensure compliance with regulatory guidelines and quality standards throughout all stages of process development and manufacturing.
Qualification
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Required
Master's degree or Ph.D. in Chemical Engineering, Biochemical Engineering, or related field.
10-12 years of hands-on experience in upstream cell culture process development, scale-up, and technology transfer within the biopharmaceutical industry.
Strong understanding of design of experiments (DOE) methodologies and their application in process optimization.
Familiarity with statistical tools such as JMP required.
Demonstrated experience in later-stage characterization and commercialization readiness.
Cell line development and characterization of Master and Working Cell Bank management experience.
Effective management and communication skills, with the ability to collaborate effectively across multidisciplinary teams.
Proven expertise in ADCs, bispecifics, and fusion proteins process development and manufacturing.
Excellent problem-solving skills with the ability to troubleshoot complex technical issues and drive effective solutions.
Benefits
401(k) matching
Bonus based on performance
Dental insurance
Health insurance
Paid time off
Stock options plan
Vision insurance
Company
Salubris Biotherapeutics
SalubrisBio was founded in August 2016 as a subsidiary of the China-based pharmaceutical company Salubris Pharmaceuticals Co. Ltd. (www.salubris.com).
11-50 employees
H1B Sponsorship
Salubris Biotherapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Early StageTotal Funding
$102MKey Investors
Shenzhen Salubris Pharmaceuticals
2024-04-22Series A· $35M
2023-03-28Corporate Round· $35M
2022-03-07Corporate Round· $32M
Leadership Team
Samuel Murphy
Chief Executive Officer
Jijun Dong
Chief Scientific Officer
Recent News
The Business Journals
2024-06-05
2024-05-23
2024-04-23
Company data provided by crunchbase
