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Gene Therapy Purification Technical Lead

Location :Novato, California

Workstyle :Onsite Only

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Overview

With accelerated review underway in the United States and Europe for our Hemophilia A drug, a second gene therapy program entering the clinic for PKU patients, and a third program in late research for Hereditary Angioedema, BioMarin continues to pioneer innovative approaches to treating rare diseases. Our commitment to gene therapy is further underscored by having developed the first and largest gene therapy manufacturing facility in the world. The scientific possibilities and the hope we offer to patients with rare diseases is enormous.

BioMarin is a midsize biotechnology company with a market cap of approximately 18 billion. Over the course of our 22 year history we have successfully launched 7 drugs for the treatment of rare diseases. Our success is due to our scientific rigor and our ability to leverage multiple therapeutic modalities. BioMarin is based in the San Francisco Bay Area and offers a comprehensive relocation program.

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Success Profile

Check out the traits we’re looking for and see if you have the right mix.

  • Decision Making
  • Influence
  • Collaboration
  • Agility
  • Leadership
  • Intellectual Curiosity

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Our CULTURE

  • Patient Focused
  • Results Oriented
  • Pioneering Science
  • Cross Functional Collaboration
  • Willing to try new ways to look at problems

Benefits

  • Healthcare

  • Medical

  • Dental

  • Vision

  • Health & Wellness Programs

  • 401(k)/Retirement plans

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" BioMarin has this, in their own DNA, an approach: they only work on projects for which they know the underlying biology."
Lon C., Chief Scientific Officer
"We’ve got to understand: What are the problems other people are trying to solve? And do we have a better way of fundamentally doing that?"
Brinda B, GVP, Corporate and Business Development

Responsibilities

SUMMARY
BioMarin’s Novato commercial manufacturing facilities produce recombinant enzyme replacement therapies using perfusion and fed batch cell culture processes and multiple column purification systems.  The Technical Lead is required to have extensive process knowledge and equipment knowledge in their
functional area. The position requires self-motivation, excellent communication, and strong troubleshooting skills. The Technical Lead will be proficient on many core manufacturing processes and operations and will provide on-the-floor training for many of the operations. In addition, the Technical Lead will have a strong understanding of Continuous Improvement on the floor and will serve as a
liaison for other technical functions which manufacturing interacts with.

The position reports directly to a manufacturing supervisor and requires shift work, potentially including weekends, off hours, and holidays.
Processing
 Responsible for performing daily operations on the production floor, including training and
troubleshooting to ensure that all operations are in full compliance and safety guidelines.
 Strong knowledge and experience in all aspects of process theory, equipment, and compliance
 Technical proficiency in assigned area (Cell Culture or Purification) and ability to provide technical
instruction and training on the various processes to their shift team
 Ability to perform operational and production tasks in respective work area
 Expected to be on the MFG floor overseeing operations minimum 80% of the time with 20% of the
time dedicated to off the floor work
Technical Expertise
 On-the-floor equipment and process Subject Matter Expert (SME)
 Assist with equipment maintenance and CMMS management
 Author minor changes Standard Operating Procedures and Batch Records
 Partner with Bioprocess Specialists, MSAT, and/or Validation as necessary
 First point of contact for equipment and process troubleshooting
 Works as an on-the-floor SME for many electronic systems including CMMS, JIRA, LIMS, PI, and SCADA

Manufacturing Support
 SME for on-the-floor Continuous Improvement concepts—A3 thinking, 5S, etc.
 Will support the execution of Human and Organizational Performance (H&OP)
 On-the-floor contact for process changes and new equipment implementation
 May assist with initiating process deviations and gathering initial details relevant to the event.
 Supports and assists with the changeover process between campaigns (CR and binder owner)
 Schedules the changeover walkthrough with QA for the designated areas
Contribution
 Ability to assist with moderate level projects
 Effective interaction with peer Leads across manufacturing to create alignment and improvement
 Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities
 Provides direction and hands-on training for staff
 Involved in technical decision-making of the process with the supervisor
 Lives department values and sets the standards for others to operate
 Fosters an environment of compliance, work ethics and development

EDUCATION
 B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination
of education and experience.

EXPERIENCE and EXPERTISE
 5+ years of relevant industry experience
 Demonstrated technical expertise
 Working knowledge of process automation and associated process equipment
 Proven technical and communication skills
 Identify and drive opportunities for process optimization

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 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
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About our location

Novato

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Our Benefits

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Hiring Insights

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Meet Our Team

From internationally renowned scientists to patient advocates, BioMarin Hemophilia has brought together the right people.

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In the News

BioMarin has entered into a preclinical collaboration and license agreement with DiNAQOR, a gene therapy platform company, to develop novel gene therapies to treat rare genetic cardiomyopathies.

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