Laboratory Manager, Biopharmaceutical Testing

Laboratory Manager, Biopharmaceutical Testing
Ref No.: DJa123
Location: Westmeath, Offaly, Longford
Salary:
Experience required: 3 - 4 years
Job Type: Permanent

Summary: Our client, a leading global contract research organisation based in the Midlands is looking to recruit a Laboratory Manager with Biopharmaceutical Testing experience.

Description:
Laboratory Manager, Biopharmeutical Testing
This role is responsible for overseeing all aspects of the laboratory operations to ensure efficient and effective management of company resources. The objective is to supervise and assist group leaders and scientists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. To plan, direct and implement improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. This position assists the division director in strategic planning, business development and expansion initiatives by providing resource utilisation predictions for a department.

The role will have direct supervisory responsibility and will have full accountability for hiring, discipline, performance appraisals and salary review. Other duties and responsibilities also include but are not restricted to:
• Overseeing daily operations of the laboratory in the stability, QC, method development/validation and GMP support areas to ensure compliance to company SOP's and policies as well as client timelines and needs are met.
• Procuring and allocating personnel and analytical instrumentation, IT and space needs to appropriate areas based on business needs.
• Reviews and approves study protocols, project status reports, final study reports and other project-related technical documents
• Designs experimental study and participates in technical troubleshooting
• Reviews data for technical quality and compliance to protocols, methods and SOPs. Reviews and approves laboratory investigations, deviations, QA facility and data audits. Leads client and FDA audits
• Responds to clients questions and needs; leads client technical meetings
• Assists in preparation of proposals, project definition and pricing.
Ideally you will be educated to a Bachelor's or advanced degree (MSc or PhD) in Chemistry or related equivalent, with management experience a biophamaecutical testing environment. This will also include:
• Stability/QC/analytical R&D/project and program management
• Direct supervision of technical staff
• Experience with facility and laboratory design, set-up and qualification.
• Able to independently lead optimization or development of analytical methods appropriate to background.
• Able to independently create presentations and conduct presentations outside PPD
• Full knowledge of EMEA, FDA, GMP and ICH guidelines and other regulatory requirements for analytical support of studies at various stages of drug development.
• Full knowledge and experience with a variety of analytical instrumentation operation and troubleshooting
• Knowledge and experience with Biotechnology, for example: Proteins, Peptides, Antibodies, Oligonucleotides