Allergan Technology Transfer Specialist in Mayo, United States
Technology Transfer Specialist
Mayo, Connaught, Ireland at https://agn.referrals.selectminds.com/jobs/7186/other-jobs-matching/location-only
Nov 05, 2018Post Date
Working on an exciting new project for a Biologic GMP Pre Filled Syringe which includes installation and integration into the existing manufacturing suite. The role will be responsible for implementing necessary procedures and controls by working closely with the Pharmaceutical Technology Scientist and relevant functions to achieve the aggressive timelines to complete registration stability batches in Q42019.
• Develop and optimise a single use filtration system with the vendor of choice.
• Project manage the Botox PFS project to achieve key milestones in 2019 and beyond
• Coordinate Engineering runs and registration stability batches
• Author SOPs and documentation for the new process.
• Support SAT and Engineering runs for compounding and filling for PFS.
• Support Process Scientist and Engineering/ support functions on delivering on timelines.
• Work closely with validations, engineering, packaging, micro and other support functions to ensure everything is in place.
Education and Experience
Bachelor’s degree in Pharmaceutical, Engineering or related discipline
Minimum of 5 years experience in a GMP environment or MSc with 3 years experience
Essential Skills, Experience, and Competencies
• Experience with commercial &/or clinical manufacture.
• Excellent technical writing and communication skills.
• Proven ability to problem solve.
• People management skills are an advantage.
• Flexibility of working hours may be required to accommodate global project team meetings and filling times.
• Must be a self starter with a pro-active approach with a strong track record of delivering on projects.
• Experience with GMP regulatory inspections & working knowledge of international GXP’s (GCP/GLP/GMP) for biologics development activities.
• Pre Filled Syringe knowledge.
• Knowledge of Process Performance Qualification and Engineering runs.
• Basic understanding of Single Use Technology and Single use system validation.
• Experience with interacting in project teams at a global level.
• Understanding of analytical requirements.
• Proven track record on delivering on projects.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.