Job Description
As an In Vitro Bioassay Analyst, you will play a key role in the success of our client's contract research organization. Reporting to the Biosafety & Cell Based Assay Supervisor, you will be responsible for the maintenance and propagation of antibiotic-free cell cultures, as well as the microscopic evaluation of mammalian cells.
Key Responsibilities:
* Maintenance and propagation of antibiotic-free cell cultures.
* Competent in microscopic evaluation of mammalian cells (e.g. cell morphology, count and viability).
* Provide technical training to team members as required.
* Receipt and processing of test samples in LIMS.
* Update current standard operating procedures.
* Assist in laboratory investigations where necessary.
* Responsible for reporting progress information to Management.
* Assist in internal, regulatory and client visits/audits and respond to findings.
* Complete understanding of all regulatory guidelines.
* Liaise with the Quality Department for the generation of all departmental quality documents including audit responses, facility replies and deviation reports.
* Generation of GMP compliant SOPs, Protocols and reports.
* Generate risk assessments for laboratory and test items as required.
* Maintain Laboratory Data Integrity and compliance.
Requirements
To be successful in this role, you will require a BSc/MSc in a relevant science discipline (e.g. chemistry, biochemistry, pharmacy, and biotechnology), as well as a minimum of 3 years' relevant experience in a laboratory, preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO, CMO, CDMO Industry.