Bioanalytical Manager

This job has now expired please search on the home page to find live IT Jobs.

I am working for a leading Biotechnology company who are actively seeking a Bioanalytical Manager for their newly established facility in Limerick

This company are building the largest biotechnology manufacturing facility in Ireland at a rapid pace. The company has a strong culture of innovation and R&D.

The Bioanalytical Manager will oversee the laboratory quality control testing of in-process, stability, and final drug products. You will also technical responsibility for all bioanalytical aspects of QC testing.

Responsibilities:

Coordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support.

* Oversees product testing to ensure efficient and compliant operations.

* Investigates atypical and OOS test results as necessary.

* Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.

* Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.

* Oversee QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.

* Track and coordinate major analytical investigation and timeline of analytical validation projects.

* Monitor the team performance for Compliance events, track, assist and organize continuous improvement event.

* Interact with Regulatory Agencies as needed to ensure cGMP compliance.

* Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations

Education and Experience:

* BS in chemistry, biology or related field with 8+ years' relevant experience (pharmaceutical or biotechnology industry) in laboratory management and analytical sciences and 5+ years' experience in a supervisory/leadership capacity.

* Thorough understanding of bioanalytical techniques in a cGMP environment.

For immediate consideration please apply below with an up to date CV. Not sure yet? No CV ready? Give me a call for more information.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales