- Reference: GY45435
- Job Type: Permanent
- Location: Mayo
- Category: Science, Pharmaceutical & Food
• Lead Method Transfer and Validation activities associated with biological drug product transfer.
• Compiling of all Laboratory documentaion (e.g. SOPs, methods, Master records, Batch Records, Reports etc.).
• Good knowledge of instrumentation and method validation an advantage.
• Support regulatory inspections as required for clinical product from the WBD function.
Skills, Experience and Qualifications:
• 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.
• Biologics experience and understanding of bioanalytics an advantage (HPLC, ELISA, Western Blot etc.)
• 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.
• Excellent technical writing and communication skills.
• Proven ability to problem solve.
• A good understanding of cleaning validation (specifically analysis of samples).
• Participates in process and quality risk assessments.
• Lead and co-ordinate technology transfer activities.
• Good technical writing skills.
• Good communicator.
• Good planning and organisational skills.
• Working knowledge of Quality Management System (QMS), Laboratory Information Management Systems (LIMS), Empower.
• Knowledge of clinical development phases and associated analytical requirements.
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org