PE Global are recruiting for an Material Science Technical Specialist on behalf of our client based in Cork:
23 month contract
Emerging role for someone with 3-5 years experience with single-use technologies
This position requires the utilization of expertise relevant to biopharmaceutical materials and processes with an emphasis on single use technologies (bags, filters, tubing assemblies, drug product materials). Technical expertise in biopharmaceutical manufacturing materials is required to provide support to Commercial and Clinical manufacturing operations. This position requires a detailed knowledge and understanding of product-contacting materials, technologies, applications, and suppliers. This position can also require knowledge of industry standards that govern raw materials (USP, etc.). Candidate will assess and approve raw materials for use. Candidate will lead, develop, and implement process improvement initiatives via evaluation of current raw materials, practices, process history, equipment, and technologies.
He or she will support transfer of new processes from Process Development into a cGMP Manufacturing environment. He or she will utilize existing methods and Quality Management System tools (Veeva, TrackWise, etc.) to implement new raw materials or processes, or to make changes to existing raw materials or processes.
He or she should be detail oriented while also operating with a broad strategic perspective.
Periodic travel may be required to attend relevant professional conferences, workshops, or trainings, support technical transfer, and/or evaluate systems, processes, and technologies.
RESPONSIBILITIES:
- Identify, lead, and implement harmonization, optimization, and continuous improvement initiatives and/or projects with an emphasis on single use items and technologies
- Assist in the development of site/company standard raw material platforms and business practices
- Assess raw material supplier change notifications, complaints, etc.
- Evaluate and/or test the feasibility of new manufacturing raw materials
- Responsible for technical evaluation of proposed raw material changes to Manufacturing processes
- Support technology and process transfer to and from the Manufacturing areas or facilities to ensure developing processes align with established large-scale and/or Commercial Manufacturing raw materials and practices
- Manage raw material change requests, CAPAs, and Action Items via Veeva QMS
- Oversee project milestones, departmental goals, and carry out strategic initiatives
- Communicate progress and status of projects clearly and effectively
- Create projects, spreadsheets, and presentations via Microsoft Office programs
- Continued education on understanding of raw materials and their governing bodies
EXPERIENCE:
- Experience in Material Science, Biopharmaceutical Manufacturing, Manufacturing Sciences and Technology, and/or Process Development
- Strong knowledge of and expertise of pharmaceutical single use raw materials (bags, filters, tubing assemblies, drug product materials, chemicals, media, resin)
- Established working relationship with raw material suppliers
- Basic understanding of biopharmaceutical processes and raw materials used to support manufacturing operations
- Strong technical understanding of general biopharmaceutical manufacturing processes and techniques (bioreactor operations, depth filtration, media/buffer preparation, etc.)
- Experienced in the transfer of processes and technology to cGMP and/or clinical operations
- Experienced in cGMP and with large-scale manufacturing equipment and practices
- Knowledge and understanding of regulatory agency guidelines, expectations, and best practices
- Knowledge of raw material standards (USP, BioPhorum, etc.)
- Proven project management, organizational, and communication skills
- Proven ability to independently manage work, actions, and expectations
- Proven ability to handle multiple tasks concurrently and be flexible and adaptable
- Proven ability to meet deadlines
- Strong knowledge of and experience using Microsoft Office programs (Project, Excel, PowerPoint)
EDUCATION:
BS in Life Sciences with 3-5 years of relevant experience in Material Science, Biopharmaceutical Manufacturing, Manufacturing Sciences and Technology, and/or Process Development or MS with 2 years of relevant experience
Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV to Audrey.mccarthy@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
