Our global client is currently looking for a Drug Substance Leader for their vaccine's facility. This position is at Director level
Involve in the manufacturing process design, construction of facility, co-leading C&Q, support on PQ, site operation, PEV, calibration activities.
Supervise daily manufacturing activities under GMP compliance and ensure production timelines are met.
Collaborate with Process Development (PD), Manufacturing science and Technology (MSAT), and Project Management (FM) etc. for technology transfer, validation and related work.
Provide expertise and technical leadership in biopharmaceutical process technologies.
Communicate status of process, personnel, safety, environment, maintenance and other issues, in a timely manner to management team.
Coordinate Quality Assurance (QA)& Quality Control (QC)groups to ensure GMP compliance, manage deviation investigation and Corrective and Preventive Actions (CAPA)implementation, and support client auditing and agency inspections.
Lead continued improvement of manufacturing operation to increase efficiency and optimize the documentation (SOPs, MBR'. OJI's) to ensure they are current accurate, and clear.
Motivate, retain and develop existing group members and recruit, new staff to build a strong team, ensure training of all staff members up to date and can perform manufacturing operations safely and in compliance.
Author and review GMP documents including, but not limited to SOP/MBR/URS/FAT/SAT, as Well as review the executed batch record.
Ensure staff to complete trainings on time and up to date, and qualified to perform the operations per cGMP compliance.
Provide strong support for LSS activities within the team and facility.
Master degree or above with major in Biology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major or person with equivalent experience
In depth Knowledge in Good Manufacturing Practice (GMP)production in cell expansion, cell culture, protein purification,
Production planning, quality assurance and control or related fields.
At least 10 years' experiences in Vaccine, Biotech or pharmaceutical industry.
Demonstrated excellent management skills and leadership.
Global perspective, Strategic thinking, Strong leadership.
Excellent written and oral presentation skill,
Detail-oriented organizational skill,
Have good communication and cooperation ability and can cooperate many departments to complete deviation investigation.
Oversea experience or trainings.
This is an excellent opportunity to join an established company as it expands its Irish operations. This is a permanent full-time opportunity and comes with excellent salary and full benefits package.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aidan Crowley at 021 4289605 or send your CV to firstname.lastname@example.org