Job Description SummaryDo you enjoy solving complex problems, building relationships with collaborators, and continuously learning in a fast-paced and innovative environment? As a member of the Process Development, Biologics team you will work alongside experienced Engineers, Associates, and Scientists who collaborate closely on delivering robust, cost efficient, and innovative manufacturing processes for biologic products meeting appropriate regulatory and current good manufacturing practices (cGMP) requirements.
As a Scientist, you will lead and execute upstream process development for protein production, from experimental design through scale-up and technology transfer. Acting as a subject matter expert (SME), you will collaborate across cross-functional teams and help establish new workflows for proteins with end uses in Ancillary Material at STEMCELL!
Job DescriptionDuties and Responsibilities- Act as a SME, providing technical recommendations to cross-functional project teams for upstream process development supporting cGMP protein manufacturing
- Oversee upstream development activities, including design, risk assessment, development, and transfer of safe, efficient, and robust processes
- Analyze experimental data, presenting conclusions and findings to cross-functional teams, and develop and transfer SOPs into manufacturing
- Lead and participate in non-conformance root cause investigations, supporting the execution of corrective and preventative actions (CAPAs)
- Collaborate internally with R&D, Quality Control, Quality Assurance & Regulatory teams, and externally with contract development and manufacturing organizations (CDMOs)
Knowledge and Qualifications- Bachelors with 6+ years, Masters with 4-8 years or PhD with 2-5 years of relevant experience
- Deep understanding and practical expertise in upstream protein production process development, including optimization and scale-up using mammalian cell lines in cGMP environments
- Experience with process scale-up/down models and concepts, Design of Experiments (DoE), statistical methods, and Quality by Design (QbD) principles
- Experience in technology transfer to manufacturing facilities, including CDMOs
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.
The annual salary for this job ranges from:
$85,700.00 - $128,500.00
STEMCELL determines an individual's pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.
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