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Material Science Associate, MSAT

Location Novato, California Workstyle Open to Hybrid
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY DESCRIPTION:

This position requires the utilization of expertise relevant to biopharmaceutical processes with an emphasis on chemical raw materials (chemicals, media, resin).  Technical expertise in biopharmaceutical manufacturing chemical raw materials is required to provide support to Commercial and Clinical manufacturing operations as well as Process Development operations.  This position requires a detailed knowledge and understanding of pharmaceutical chemical raw materials (chemicals, media, resin), their applications and suppliers, as well as the industry standards that govern chemical raw materials (USP, compendia, etc.).  Employee will assess and approve chemical raw materials for use.  Employee will lead, develop, and implement process improvement initiatives via evaluation of current chemical raw materials, practices, and process history.  He or she will lead maintaining and troubleshooting existing processes by having a detailed understanding of the chemical raw materials used.  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 tools (TrackWise, Veeva, etc.) to implement new chemical raw materials or processes, or to make changes to existing chemical 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, MSAT (Technology Transfer, Process Validation, Product Technical Owners, Process Stewards), Material Operations, Supply Chain, Global Procurement, Global Supplier Quality, Quality Assurance (Validation, Operations, Raw Materials), Compliance, and Regulatory Affairs.

Periodic travel may be required to attend relevant professional conferences, workshops, or trainings, support technical transfer, and evaluate systems, processes, and technologies.

RESPONSIBILITIES:

  • Identify, lead, and implement harmonization, optimization, and continuous improvement initiatives and/or projects with an emphasis on chemical raw materials
  • Assist in the development of site/company standard chemical raw material platforms and business practices
  • Support chemical raw material vendor audits
  • Assess chemical raw material supplier change notifications, complaints, etc.
  • Support investigations into chemical raw material deviations and/or abnormal events and assess and approve subsequent corrective actions and/or changes
  • Evaluate and/or test the feasibility of new manufacturing chemical raw materials
  • Participate in the execution of small-scale validation studies to establish a broad library of approved and/or accepted chemical raw materials, vendors, etc.
  • Responsible for technical evaluation of proposed chemical 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 chemical raw materials and practices
  • Approve chemical raw material change requests, CAPAs, FUAs, and Action Items via TrackWise
  • 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:

  • Strong knowledge of and expertise of pharmaceutical chemical raw materials (chemicals, media, resin)
  • Strong knowledge of chemical raw material standards (USP, compendia, BPOG, etc.)
  • Established working relationship with chemical raw material suppliers
  • Basic understanding of biopharmaceutical processes and chemical 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
  • 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 5+ years of relevant experience or MS with 1-5 years of experience



PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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