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Area Lead, Manufacturing (Day Shift)

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Nov 24, 2023

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Job Details

Who We Are

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.

Area Lead, Manufacturing

ROLE

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


Leadership

-Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight
-Accomplishes tasks through direct and effective coordination
-Provides direction and hands-on training for staff
-Supports the management of staff
-Lives department values and sets the standards for others to operate
-Fosters an environment of compliance, strong work ethic and ongoing learning

Contribution
-Ability to take responsibility for complex projects
-Effective interaction with peer Leads across manufacturing to create alignment and improvement
-Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities

Process Knowledge
-Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
-Ability to troubleshoot, identify issues and support resolutions with technical groups
-Required to perform ongoing operational tasks in respective work area
-Uses scientific thinking and decision making in daily work


Technical Competency
-Proven experience with relevant process, theory and equipment
-Experience with process automation and functionality
-Assist with review and approval of documentation including Batch Records and logbooks

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
-Complete understanding and adherence to cGMP’s as related to commercial operations
-Support the closure of manufacturing discrepancies and change requests
-Experience with business systems (Process historian, LIMS, Trackwise, ERP, MES, etc.)

EXPERIENCE
-2+ years of relevant industry experience
-Demonstrated technical expertise in downstream processing
-Working knowledge of process automation and associated process equipment
-Proven organizational, shift leadership and communication skills
-Identify and drive opportunities for process optimization
-Ability to manage work, actions and expectations is essential

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

Shift Details: Sunday-Tuesday/Wednesday, 6AM – 7PM. Wednesday is rotating.

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.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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