Job Title:
Product Development Specialist
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.