Manufacturing Associate

Location:  Novato, California Category: Manufacturing Employment Category: Fulltime-Temporary

Description

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. 
 

Duties


Shift: Sunday-Wednesday 7am-6pm 


 


PROCESS KNOWLEDGE:
Understanding of process theory and equipment operation
Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance
Support initiatives for process optimization
Identify and elevate processing issues and support solutions
Demonstrated proficiency Gain experience with automation systems (LIMS, MES, PI, etc.)
TECHNICAL DOCUMENTATION:
Provide feedback and/or suggested changes to operational procedures
Assist in the incorporation of new technologies, practices and standards into procedures
Capable of writing and reviewing process documents
QUALITY AND COMPLIANCE:
Understanding of cGMPs as related to 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
Capability to learn and support new business systems (Track wise, ERP, etc.)
Support trending of defined department metrics

Skills



    • Operate large scale bioprocess equipment for the cell culture and purification processing

    • Perform all aspects of processing with a broad understanding of science, compliance and technical aspect

    • Display competency with process equipment and automated control systems

    • Perform cleaning and sterilization of parts and equipment used with manufacturing process

    • Broad  knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation

    • Ability to understand, apply, and evaluate basic chemistry, biology and scientific principles as appropriate for the position

    • Proficiency with compliance; adherence to standard operating procedures, batch record, good documentation practices and  data capturing

Education



    • Bachelor’s degree in science related area or engineering or Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.

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