Scientific Innovation Specialist
2 days ago
Role Overview
This position plays a pivotal role in defining and driving the completion of all quality control required sections for Annual Product Quality Review reports. Additionally, it involves coordinating and managing the Method Performance Monitoring Program, incorporating Reference Standard monitoring and invalid rate tracking.
Responsibilities:
- Define, schedule, coordinate, and drive the completion of all QC required sections for APQR reports.
- Coordinate and manage all Annual Trend Reports.
- Support harmonisation of trending across BMS network sites.
- Oversee and manage the Method Performance Monitoring Program, incorporating Reference Standard monitoring and invalid rate tracking.
- Bachelor's degree in Biochemistry or related discipline.
- Minimum 3 years hands-on experience in a GMP Laboratory Setting and QC Trending experience is preferable, preferably Biologics.
- Strong fundamental understanding of protein biochemistry is desirable.
- Technical expertise in Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, Bioassay) and compendial techniques (KF, HIAC).
The organisation is committed to supporting employees in their professional growth and development. We strive to create a work environment that is inclusive, supportive, and challenging.
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