Senior Specialist, QC Trending

BMS - Bristol-Myers Squibb

BMS Cruiserath Biologics is seeking to recruit on a permanent contract Senior Specialist, QC Trending, reporting to Manager, QC Trending.

Responsibility for defining, scheduling, coordinating, and driving to completion of all QC required sections for Annual Product Quality Review (APQR) reports.
Responsibility for defining, scheduling, coordinating, and driving to completion all Annual Trend Reports.
Support harmonisation of trending across BMS network sites.
Responsibility for oversight and management of the Method Performance Monitoring Program, incorporating Reference Standard monitoring and invalid rate tracking.
Management of trend related investigations, in association with the QC Analytical Trending Lead.
Point of contact for internal and external manufacture sites, attend meetings where necessary.
Co-ordination of trend assessments with the relevant SME’s and ensure delivery to meet due dates.
Review trend limits from the manufacturing site and ensure timely implementation at CRU QC e.g LIMS.
Addition of new products to the trending programme post successful transfer to the CRU QC teams.
Compliance with Standard Operating Procedures and Processes.
Approval of SOPs, trend data, non-conformances and reports.
Participate in regulatory agency inspections as required.
Supporting Network teams as they pertain to QC Trending.
Manage and contribute to the achievements of department productivity and quality goals.
Participate in QC Release ad-hoc activities as required to support QC

Minimum of a BSc in Biochemistry or related discipline
Minimum of 3 years hands on experience in a GMP Laboratory Setting and QC Trending experience is preferable, preferably Biologics
A strong fundamental understanding of protein biochemistry is desirable. Technical expertise should include the following Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, Bioassay) and compendial techniques (KF, HIAC)
Previous experience with analytic laboratory data systems (Electronic Notebook, Velquest) would be advantageous.
The successful candidate must demonstrate a problem-solving ability, as well as the ability to prioritise objectives from multiple projects.
The successful candidate must demonstrate excellent time management and organisational skills. Excellent communication and the ability to contribute to and lead in a team based collaborative environment is essential.

Don't forget to mention EuroPharmaJobs when applying.

Share this Job