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 Senior Scientist, Process Development (Upstream) you'll lead the planning and technology transfer of upstream processes for protein production. This is an exciting opportunity to leverage existing upstream process development and technology transfer experience and grow as we establish new workflows for GMP projects at STEMCELL!
Job DescriptionDuties and Responsibilities:- Provide technical and strategic recommendations to the cross-functional project team and senior management for upstream process development activities towards cGMP protein manufacturing for Ancillary materials
- Create the upstream development plans for clinical protein production and be accountable for resulting project deliverables
- Provide oversight and guidance on upstream processes and their technology transfer either internally or with CDMOs
- Nurture collaborations with cross-functional stakeholders, including R&D, Quality Control, Quality Assurance & Regulatory teams, addressing critical quality attributes and critical process parameters based on product's intended use and user requirements
- Author and review process descriptions, technical reports, technology transfer documentation, SOPs, batch records, regulatory filings and other documentation as needed
- Support manufacturing operations by using technical expertise to ensure successful manufacturing campaigns and support NCR investigations and identification of CAPAs
Knowledge and Qualifications:- Doctoral degree with at least 5 years relevant experience or Master's degree with minimum 8 years relevant experience in upstream process development &/or MSAT for antibody/protein products destined for cGMP manufacture
- Thorough understanding and hands-on experience of developing upstream processes for use in a cGMP manufacturing environment, ideally for Ancillary materials
- Experience in technology transfer to manufacturing facilities, including CDMOs
- Experience in leading and managing cross-functional projects is required
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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:
$103,800.00 - $155,600.00
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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