Senior Scientist, Process Development (Downstream)
About The Position
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 (Downstream) you’ll lead the planning and technology transfer of downstream processes for protein production. This is an exciting opportunity to leverage existing downstream process development and technology transfer experience and grow as we establish new workflows for GMP projects at STEMCELL!
Requirements
- Doctoral degree with at least 5 years relevant experience or Master's degree with minimum 8 years relevant experience in downstream process development &/or MSAT for antibody/protein products destined for cGMP manufacture
- Thorough understanding and hands-on experience of developing downstream 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
Responsibilities
- Provide technical and strategic recommendations to the cross-functional project team and senior management for downstream process development activities towards cGMP protein manufacturing for Ancillary materials
- Create the downstream development plans for protein production and be accountable for resulting project deliverables
- Provide oversight and guidance on downstream 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
Benefits
- competitive salary
- excellent benefits
- meaningful career development opportunities
- health benefits
- retirement savings
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What This Job Offers
Job Type
Full-time
Career Level
Senior
