Lead, Manufacturing (Front End Nights)

Description

Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. 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.

Role

Shift Lead, Manufacturing GMP personnel throughout BioMarin are tasked with developing drugs for clinical trials and scaling their production for the commercial market. Theseindividualsare responsible for establishing and maintaining BioMarin’sinnovativemanufacturing processes and facilities, ensuring quality assurance and quality control to meet regulatory standards, procuring essential goods and services to support manufacturing, and managing the global distribution 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 staffwith supervisor
• 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 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
• 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
• Support the closure of Manufacturing owned Quality Records (deviations, change requests)
• Other duties as assigned.

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 (PI ProcessBook, LIMS, Veeva, SAP, 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.A./B.S. desired but not required

Shift Details: Sun/Tues-Sat 6PM-7AM. Saturday is rotating. 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.