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Scientist III/ Principal Scientist Upstream Cell Culture Process Dev.
3 months ago
Salubris Biotherapeutics, Inc. (or SalubrisBio) is a science-driven biotechnology company dedicated to the discovery and global development of novel antibody therapeutics for the treatment of cancer, cardiovascular and metabolic diseases. We strive to develop novel therapeutic molecules that provide clinically meaningful improvements in disease burden and quality of life to patients with significant medical needs.
Position Summary
We are seeking a talented and experienced Scientist III/Principal Scientist to join our Upstream Cell Culture Process Development Team. The ideal candidate will lead technical aspects of cell line development and upstream cell culture activities for antibody-based pipeline programs with a specific focus on antibody drug conjugates (ADCs), bispecifics, and fusion proteins. The successful candidate will drive highly productive cell line development, process development, process optimization and characterization, scale-up, and technology transfer initiatives to support the manufacturing of biopharmaceutical products through all phases of clinical and commercial manufacturing, including BLA readiness.
Responsibilities:
- Lead cell line development and cell banking activities ensuring optimal cell line productivity, titer and product quality.
- 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, technology transfer and process control strategy documents to control and define process evolution through clinical stages leading into commercial stage.
- Serve as liaison to support interaction and management of contractors and vendors related to cell line development and cell culture related activities.
- Collaborate closely with cross-functional teams including other members of 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 cell line development and 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.
- 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 while working on antibody-based products.
- 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 cell culture process characterization and commercialization readiness.
- Cell line development and characterization of Master and Working Cell Bank management experience will be highly preferred.
- 2+ years of managerial experience leading team of scientist(s) and/or associates.
- Experience with PPQ readiness, execution and authoring of BLA sections will be highly preferred.
- 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.
