Under general direction, perform testing and other activities in functions supporting the Bioanalytics department.
- Plan and perform Bio-Analytical testing such as Flow, ELISA, cell count, cell viability, re-sidual bead assessment, qPCR, Potency, in collaboration with experienced team members, if necessary.
- Perform all testing and activities compliantly following appropriate SOPs and proce-dures.
- Maintain controls, reagents and reference standards to support testing.
- Work on shifts covering daytime / evening and one or both weekend days.
- Review data generated by other team members.
- Train others.
- Contributes to the setup and optimization of infrastructure or specialized facilities e.g. cell culture or qPCR labs as an expert w/ adequate guidance.
- Evaluate/qualify and maintain lab equipment.
- Execute validation/transfers/optimization of test methods as per appropriate protocols.
- Contribute to OOS/OOE and deviation investigations.
- Interface with regulatory agencies during audits.
- Support 5S and Lean projects.
- Continually identify areas for improvements in project work.
- Knowledge of LabWare LIMS and/or other QC data systems.
- Maintain GMP/GLP quality systems.
- Review of laboratory logbooks and laboratory cleaning.
- Performing daily equipment startup and PQ
- Assure stock of reagents and materials
Commercial degree as BTA or MTA or BSc degree (candidates with an MSc degree might get considered also) in biology, chemistry, biochemistry, microbiology or other related discipline
Professional experience and competencies
- 2-5 years (for candidates with a Masters degree 0-2 years) industry working experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
- Understanding of the concepts of GMP and GLP
- Knowledge of bioassay test methods like Cell counts, Elisa, Flow cytometry.
- Ability to communicate clearly with a variety of individuals in various aspects of operations.
- Strong written and verbal communication skills are essential.
- Ensure customer satisfaction and react to customer requests
- Strong ability to work independently, compliantly and results driven.
- Pays attention to detail
- Able to proof work and identify non-standard format or wording, and errors within documents