Lead, Manufacturing (Day Shift)
BioMarin Pharmaceutical Inc.
6 hours ago
On-site
Novato, CA
Operations
Shift Lead, Manufacturing
Responsibilities:
- Accountable for daily operations in the area; communicate effectively to make decisions, troubleshoot, and maintain schedule adherence with minimal oversight
- Coordinate tasks directly and effectively
- Provide direction and hands-on training for staff
- Support supervisor/management of staff
- Live department values and set standards for others
- Foster a compliant work environment with strong work ethic and ongoing learning
- Take responsibility for moderate-level projects
- Interact with peer Leads across manufacturing to create alignment and improvement
- Partner with support groups (Facilities, Validation, Quality) to complete scheduled activities
- Apply strong knowledge of process theory, equipment, and compliance; troubleshoot and support resolutions with technical groups
- Perform ongoing operational tasks in the respective work area; use scientific thinking and decision-making in daily work
- Provide technical documentation support: give feedback/suggest changes to operational procedures; help incorporate new technologies/practices/standards; write and review process documents
- Assist with review and approval of documentation including Batch Records and logbooks
- Support closure of manufacturing-owned Quality Records (deviations, change requests)
- Complete understanding and adherence to cGMPs as related to commercial operations; support closure of manufacturing discrepancies and change requests
- Use business systems (PI ProcessBook, LIMS, Veeva, SAP, MES, etc.)
- Other duties as assigned
Qualifications / Skills / 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
- Ability to identify and drive opportunities for process optimization
- Strong knowledge and experience in relevant process theory, equipment, and compliance
- Ability to troubleshoot issues and support resolutions with technical groups
- Ability to manage work, actions, and expectations
- Assist with and support approval/review of Batch Records, logbooks, and process documents
Education:
- B.A./B.S. desired but not required
Shift Details:
- Wed/Thurs-Sat, 6AM–7PM (Wednesday rotating)
Responsibilities:
- Accountable for daily operations in the area; communicate effectively to make decisions, troubleshoot, and maintain schedule adherence with minimal oversight
- Coordinate tasks directly and effectively
- Provide direction and hands-on training for staff
- Support supervisor/management of staff
- Live department values and set standards for others
- Foster a compliant work environment with strong work ethic and ongoing learning
- Take responsibility for moderate-level projects
- Interact with peer Leads across manufacturing to create alignment and improvement
- Partner with support groups (Facilities, Validation, Quality) to complete scheduled activities
- Apply strong knowledge of process theory, equipment, and compliance; troubleshoot and support resolutions with technical groups
- Perform ongoing operational tasks in the respective work area; use scientific thinking and decision-making in daily work
- Provide technical documentation support: give feedback/suggest changes to operational procedures; help incorporate new technologies/practices/standards; write and review process documents
- Assist with review and approval of documentation including Batch Records and logbooks
- Support closure of manufacturing-owned Quality Records (deviations, change requests)
- Complete understanding and adherence to cGMPs as related to commercial operations; support closure of manufacturing discrepancies and change requests
- Use business systems (PI ProcessBook, LIMS, Veeva, SAP, MES, etc.)
- Other duties as assigned
Qualifications / Skills / 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
- Ability to identify and drive opportunities for process optimization
- Strong knowledge and experience in relevant process theory, equipment, and compliance
- Ability to troubleshoot issues and support resolutions with technical groups
- Ability to manage work, actions, and expectations
- Assist with and support approval/review of Batch Records, logbooks, and process documents
Education:
- B.A./B.S. desired but not required
Shift Details:
- Wed/Thurs-Sat, 6AM–7PM (Wednesday rotating)