Material Science Technical Specialist

Location:  Cork, Ireland Category: Manufacturing Science and Technology Employment Category: Fulltime-Temporary

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Description

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Material Science Technical Specialist
12 month contract
SUMMARY DESCRIPTION: 
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.).  Employee will assess and approve raw materials for use.  Employee 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.
This position involves close collaboration with several key groups within Technical Operations including, but not limited to, Clinical and Commercial Manufacturing, Process Development, Drug Substance Technologies (Technology Transfer, Process Validation, Product Technical Owners, Process Stewards), Drug Product and Device Technologies, Supply Chain Operations, Product Supply Chain, Global Sourcing and Procurement, Global Supplier Quality, Quality Assurance (Validation, Operations, Raw Materials), Quality Control Raw Materials, Compliance, and Regulatory Affairs.
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



Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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