Downstream Process Expert
4 days ago
About the Job:
We are looking for an experienced Downstream Process Expert to join our team at Pe Global (UK). The successful candidate will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Downstream manufacturing.
The role is accountable for timely completion of commercial sustaining and technical transfer related milestones, with particular emphasis on new product introduction, Process Validation (PPQ), Continued Process Verification (CPV), Risk Assessment (using QRM tools), and supporting technical and manufacturing deviations.
Key Responsibilities:
- To lead or support the continuous process verification program at ADMF.
- To support the changes in raw materials and consumables.
- To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
- To identify and implement process improvements, e.g. yield, cycle time reduction.
- To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
Requirements:
- BSc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
- Experience of authoring CMC sections of regulatory submissions.
- Minimum 3+ years' experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
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