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


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


 


WORK ENVIRONMENT/PHYSICAL DEMANDS


Consists of strenuous, repetitive work. The following list of physical movements maybe used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.


Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.


May require work around loud equipment.


The use of personal protective equipment will be required.


Requires various shift based work and off hours

Skills



    • Strong communication skills—verbal and written

    • Ability to work in a team environment which includes good conflict resolution and collaboration

    • Displays good initiative to identify areas for improvement and implement solutions

Education



    • Bachelor’s degree in science related area or engineering

    • 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.