DS Upstream Processing Lead

DS Upstream Processing Lead

Our client, a Global Pharmaceutical company is currently looking for a DS Upstream Processing Lead to join their site in Dundalk.

Responsibilities:

• Overall responsibility for the Drug Substance Upstream Manufacturing teams at the Dundalk Vaccine Facility
• Key role in the manufacturing process design, construction of facility, co-leading C&Q, support on PQ, site operation, PEV, calibration activities.
• Responsible for collaboration with functions such as Process Development, Manufacturing Sciences & Technology, Engineering and Project Management related groups for technical transfer and validation.
• Responsible for collaborating with QA & QC groups to ensure performing under GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
• Responsible for establishing and maintaining all GMP manufacturing systems for your area including Batch Records, SOPs, Training, Safety etc.
• Responsible for achievement of key metrics (production, quality, safety) for the USP area.
• Strive on continual improvement of manufacturing operation to make it more efficient, optimize related document
• (SOPs, MBRs & OJTs) and make sure they are current, accurate, and clear when using
• Motivate, retain, and develop existing group members and recruit new staffs to build a strong team.
• Make sure all staff members are well trained with current training module and can perform manufacturing operations efficiently, safely, and compliantly         
• Assist department head to coordinate among groups/ departments to complete production missions as schedule and deal with routine administrative affairs.
• Main point of contact for Upstream manufacturing for audits (GMP and Client)

Requirements:

• Bachelor’s degree or above preferably in the areas of science / engineering
• Significant Experience in Biologics / Vaccines Upstream Manufacturing Processing production unit operations
• A minimum of 10 years relevant experience in Vaccine, Biotech or pharmaceutical industry.
• Must be a strong leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
• Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science Engineering professionals for organisations 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 contact Fred Chesne on +353 (85) 178 6539 or send your CV to fchesne@berkley-group.com