Engineer 1/2, MSAT Frontline Downstream

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 

Manufacturing Sciences & Technology (MSAT) Frontline staff are technical and process stewards of commercial cGMP Manufacturing across multiple production platforms. MSAT Frontline staff are accountable for investigations and resolution of process-related deviations investigations. The team manages performance monitoring and process knowledge at the Novato site.   

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 individuals 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.  

 

KEY RESPONSIBILITIES   

• PROCESS KNOWLEDGE:  
  • Ability to apply technical knowledge of biopharmaceutical processes (cell culture, purification, etc.) and engineering experience to resolve process issues.
  • Support manufacturing process optimization and improvement.
  • Skill with performance monitoring tools and their application and interpretation.   
• TECHNICAL DOCUMENTATION:  
  • Assist in the incorporation of new technologies, practices and standards into procedures
  • Capable of writing and reviewing process and workflow documents, including investigations, campaign technical reviews, APRs.   
• QUALITY AND COMPLIANCE:  
  • Understanding of cGMPs as related to Clinical and Commercial Operations.  
  • Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)   
• BUSINESS:  
  • Ability to participate on projects and contribute to outcomes.  
  • Collaborate cross-functionally to meet the goal of planned and predictable delivery of product to patients  

 

REQUIREMENTS:

Education: Bachelor Degree in Science or Engineering is preferred

Experience: GMP manufacturing or purification method development in a drug development company, or process engineering.

 

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.