
Product Development Specialist
2 days ago
Key Responsibilities:
- Collaborate with cross-functional teams to develop and improve drug product manufacturing processes.
- Identify and mitigate technical and manufacturing risks through process comparisons and risk assessments.
- Develop and implement change control, deviations, and CAPAs in the quality management system.
- Lead investigations and root cause analysis for deviation resolution and initiate process improvement projects.
- Ensure compliance with specifications and regulatory guidelines by collaborating with project teams.
Requirements:
- Strong understanding of MSAT, process development, or technology transfer, with hands-on experience.
- Background in large-scale processing of biologic drug products, with proficiency in technical writing and organizational skills.
- Ability to identify, communicate, and implement continuous process improvements.
About Us:
Our company develops transformative medicines for patients with significant unmet medical need using our expertise in genetics and molecular biology.
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