ProClinical is currently seeking a Biologics - Tech Transfer Manager for a management consulting group that provides global compliance, remediation and project management services to the medical device, pharma and biotech industries. This is a contract role based in Limerick, Ireland.
- 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 Regeneron 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.
Skills and Requirements:
- 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.
- A qualification in Project Management is desirable.
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44 203 8261 330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.