Position Details

Job Purpose:
This role will be responsible for the setup and execution of bioassay product testing and supporting (validation) assays at the Phibro Sligo manufacturing site.
The role is an individual contributor role, the person must be a self-starter, with significant practical and academic experience in test method/assay development in the biotechnology and/or pharmaceutical industry. The person will require excellent interpersonal skills, the ability to manage their own time, work to deadlines and produce a high standard of quality in their work. 

Key Responsibilities:
- Qualification of new laboratory equipment as required. 
- Perform GMP compliant and timely transfer of analytical methods. 
- Generation of necessary documentation to support ongoing operation of the QC laboratory, i.e. procedures, work instructions and protocols. 
- Completing of training of other analysts test methods to be transferred. 
- Performs sample analysis in accordance with standard operating procedures (SOPs).
- Coordinates the use of external test laboratories when required. 
- Maintains and where required, imports laboratory reagents, media and supplies. 
- Conducts laboratory investigations and generates reports in response to invalid assays, deviations, OOS/OOT results. 
- Initiates and completes CAPAs and Change Controls in accordance with site procedures. 
- Presents analytical date/trend reports clearly and concisely to management. 
- Provide out of hours On Call support for Critical Quality Impact Systems. 
- Ad hoc duties as required. 

Job Specific Technical, Functional, and Professional Competencies:
- A background in Analytical Method Developmment, Validation and/or Statistical Quality Control.
- An understanding of GMP, ICH and compendia regulations and guidance's. 
- Demonstrated ability in leading root cause analysis and effective investigation practices. 
- Excellent problem solving (facilitation and application of tools), risk management and decision-making skills. 
- Experience in laboratory based in aseptic techniques. 
- Excellent collaboration skills. 
- Excellent attention to details and significant data review experience essential. 
- Excellent technical writing skills including deviation reports and validation reports. 
- Effective time management and multi-tasking skills. 
- Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail. 
- Excellent communication skills, both verbal & written. 
- Adaptable and flexible, willing to travel when needed. 

Essential Education and Experience:
- At least 3 years' experience in the biotechnology and/or pharmaceutical industry, with operational experience of quality laboratories and/or new product/assay introductions. 
- Demonstrated competency in bioassays including polymerase chain reaction (qPCR and RT-PCR) and enzyme linked immunosorbent assays (ELISA) is required. 
- Experience in immunological assays such as viral titrations and cell-based bioassays is an advantage. 
- Experience of analytical transfer programs and method development/validation. 
- Experience in authoring, review and execution of analytical and process validation studies and reports is a must. 
- Proficient in written and spoken English. 
- Experience in clean room activity is an advantage.

Desirable Education and Experience:
- A minimum of an Honours degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceuticals). A Master degree is an advantage. 

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