Job Opportunity

Job Opportunity

QC Potency Senior Analyst

QC Potency Senior Analyst

Ireland Posted 2024-05-13

Company Description

WuXi Vaccines, a subsidiary of WuXi Biologics, focuses on human vaccine discovery, development and manufacture. An exciting new addition to the WuXi Biologics family, WuXi Vaccines will bring to the global vaccine industry the world-class integrated platforms and CDMO business model on which WuXi Biologics reputation is based. In development is an integrated vaccine manufacturing facility with 240 million US Dollar investment, including drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC), dedicated to manufacturing our partner's vaccine products for the global market.

Job Summary

The QC Potency Senior Analyst will be part of our Bioassay & Potency group and will report to the Potency Lead. The role will be be responsible for maintaining regulatory compliance through established programs for laboratory testing, maintenance and training.

Essential Duties and Responsibilities

Execute cell-based Potency testing to the highest standard in compliance with internal procedural requirements
Serve as a technical contributor to develop, qualify, and/or validate cell-based Potency methods to support QC release and stability testing in a cGMP environment
Prepare, and review technical documents including methods, qualification and validation protocols and reports, etc
Provide technical guidance to junior analysts to support deviations, atypical/OOS investigations, change controls, and CAPAs. Guide method trouble-shooting and implement improvements to existing methods as needed
Work collaboratively with clients for method validation and routine testing to meet project cGMP release/stability testing needs
Work with supervisors and other team members to review and monitor method performance
Ability to contribute regulatory inspections from FDA, EMA, HPRA, etc. and cGMP audits from clients, as well as internal Quality Assurance

Experience

Previous experiences in a Cell-based Potency/Bioassay in GMP environment is required
Knowledge & experiences with cell based assay and/or qPCR methods is preferred
Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-2 or 3 would be an advantage
Strong technical know-how to guide the team to maintain a leading industry role in bioassays. Knowledge of the biological principles behind mechanisms of drug action, cellular pathways and structure – function relationships
Comfortable in a fast-paced company start-up environment and able to adjust workload based upon changing priorities
Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required

Qualifications

PhD, MS or BSc in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or other related field

Behavioural Competencies

Excellent communications skills (verbal, written, and presentation skills)
Good computer operation skill, intermediate level in Microsoft Word, Excel, PowerPoint etc.
Critical thinking, scientific reasoning and problem solving skills
Good technical writing skills
Adapt to changing priorities

Apply now