Lead, Manufacturing (Day Shift)

BioMarin Pharmaceutical Inc.•Novato, CA

35d

About The Position

GMP personnel throughout BioMarin are tasked with developing drugs for clinical trials and scaling their production for the commercial market. These individuals are responsible for establishing and maintaining BioMarin’s innovative manufacturing 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.

Requirements

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

Responsibilities

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 with supervisor
Lives department values and sets the standards for others to operate
Fosters an environment of compliance, strong work ethic and ongoing learning
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
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
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.
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
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.)