Collins McNicholas

• MSc degree with three years experience or a degree in a Science or Engineering discipline with five or more years of applied experience in Pharma/ Biologics.
• Experience with commercial & / or clinical manufacture.
• Excellent technical writing and communication skills.
• Proven ability to problem solve.
• Biologics experience and understanding of bioanalytics an advantage (HPLC, ELISA, Western Blot etc.)
• A good understanding of cleaning validation (specifically analysis of samples).
• Participates in process and quality risk assessments.
• Supports technology transfer activities as needed.
• Support NPI activities and lead various aspects to ensure all necessary processes and procedures are in place to be audit ready.
• Experience with GMP regulatory inspections.
• Experience of managing & coordinating analytical method transfer activities.
• Experience with interacting in project teams at a local/global/corporate level.

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