- Reference: GY43757AO
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
Summary: The Project Manager will work with the Manufacturing Sciences and Technology (MSAT) group in the US to transfer manufacturing processes to Ireland and partner facilities. The position will also focus on ensuring site to site consistency after the processes are successfully transferred. The Project Manager will also provide floor support during operations of manufacturing campaigns, review process data to ensure operational consistency and provide support for investigations.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Work with all relevant departments to coordinate technology transfer activities.
• Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities.
• Review technology transfer protocols and reports, manage document exchange (which includes documents such as SOPs, SPECs, validation, raw material and instrument qualification documents, batch records, etc.).
• Provide process transfer support to external facilities, including generation of process descriptions and facility fit comparisons.
• Organize and lead meetings to support transfer activities.
• Track team activities and timelines to ensure that the deliverables within the project plan are met and are on-time.
• Prepare, distribute & present project status reports to project team members and management.
• Manage and set priorities for specific projects/programs.
• Provide technical support and training of manufacturing personnel to improve understanding of both cell culture and purification operations across the manufacturing organization.
• Assist in the writing and review of manufacturing records, batch sheets and SOPs.
Provide manufacturing descriptions and technical evaluations for regulatory filings and inspections.
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
• Provide and schedule floor support in the processing areas during manufacturing operations.
• Lead special projects as assigned.
Education and Required Skills:
• BS in Biological Sciences or Engineering with 7+ years of relevant experience in a cGMP environment; relevant Masters or PhD may be considered in lieu of industry experience.
(Level commensurate with experience.)
• A qualification in Project Management is desirable.
Knowledge and Skills:
• Ability to communicate clearly the timelines and important milestones
• Ability to adapt to a quickly changing environment.
• Solid knowledge of cGMP and other applicable regulations.
• Ability to effectively communicate issues and ideas with peers and with management.
• Ability to facilitate meetings with cross functional teams.
• Demonstrated interpersonal, written, and oral communication skills.
• Ability to build effective working relationships throughout the organization.