Associate Bioprocess Specialist

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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.

The Manufacturing Associate Bioprocess Specialist reports to the Manufacturing Operations Team Lead, and is responsible for all aspects of the production process including but not limited to the below main areas of responsibility of this role.

 The role is responsible for providing support to the Manufacturing team with additional Bioprocess specialist tasks as defined, but not limited to, below, in addition to performing all duties associated with the role of a biotechnician.

• All core responsibilities of Manufacturing Biotechnician role. 
• Actively support the Bioprocess Specialist as a Point of Contact with the Manufacturing Biotechnician role.  
• Leading and supporting investigation and resolution of process investigations as required. 
• Rapid response troubleshooting of Process specific equipment and escalations. 
• Training of Biotechnicians on operational OJTs including awareness training, Instructor led training and additional training as required. 
• In depth knowledge of operational control systems in respective operational areas. 
• Have an SME understanding of the applicable process control documentation. 
• Gather and provide required information for the escalation pathway to support clear communications through the tier levels and support Process team decisions. 
• Support inspections/audit where required. 
• Assisting with writing, review and revision of manufacturing documentation as necessary. (e.g. deviations, standard operating procedures and test scripts etc.)·  
• Other duties as assigned. 

• Proficiency in the operation of all equipment used in the respective functional area of responsibility.
• Strong understanding of biopharmaceutical manufacturing processes.
• Experience with technical troubleshooting of process and equipment issues.
• Experience with production systems used during biopharmaceutical production (e.g. DeltaV, MES, SAP, SIMCA).
• Experience completing root cause analysis investigations and Continuous Improvement projects is desirable.
• Excellent communication skills and experience relaying technical information.

Education:
Bachelor’s degree in biotechnology, Chemical or Biochemical Engineering, Biochemistry, Bio-systems Engineering, or related field (or equivalent experience) is preferred.

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.