Lead, Manufacturing (Day Shift)
BioMarin Pharmaceutical Inc.
6 months ago
On-site
Novato, CA
Operations
Role
GMP personnel developing drugs for clinical trials and scaling production for the commercial market, including establishing and maintaining manufacturing processes and facilities, ensuring quality assurance and quality control meet regulatory standards, procuring goods/services to support manufacturing, and managing global distribution of drugs.
Key Responsibilities
- Leadership: Accountable for daily area operations; communicate effectively to make decisions; troubleshoot; ensure schedule adherence with minimal oversight; coordinate tasks; provide direction and hands-on training; support staff management with supervisor; model department values; foster an environment of compliance, strong work ethic, and ongoing learning.
- Contribution: Own moderate-level projects; collaborate with peer Leads across manufacturing for alignment and improvement; partner with support groups (Facilities, Validation, Quality) to complete scheduled activities.
- Process Knowledge: Strong knowledge/experience with relevant process theory, equipment, and compliance; troubleshoot issues and support resolutions with technical groups; perform ongoing operational tasks in the work area; apply scientific thinking and decision-making.
- Technical Competency: Proven experience with relevant process, theory, and equipment; experience with process automation; assist with review/approval of Batch Records and logbooks; support closure of manufacturing-owned quality records (deviations, change requests).
- Other duties as assigned.
Required Skills/Qualifications
- 2–4+ years manufacturing experience
- Familiarity with manufacturing software, bioreactors, and CIP skids
- Communication with other groups
Desired Skills/Qualifications
- Delegating work
- 0–2 years experience leading a team
- Following production schedule
- Experience with Oracle EBS, MES, Microsoft Teams
Education
- BA/BS desired (not required)
Equipment
- Bioreactors, cell settlers, TFF, pH adjust, CIP skids, media tanks, labwashers, autoclaves, single-use materials
Contacts
- Interaction with manufacturing, automation, facilities, instrumentation, QA, QC, validation, scheduling, distribution, NTS, EHS&S
Shift / Location / Travel
- Shift: Thursday–Saturday (plus alternating Wednesday) 6am–7pm
- Onsite only
- Travel required: None
GMP personnel developing drugs for clinical trials and scaling production for the commercial market, including establishing and maintaining manufacturing processes and facilities, ensuring quality assurance and quality control meet regulatory standards, procuring goods/services to support manufacturing, and managing global distribution of drugs.
Key Responsibilities
- Leadership: Accountable for daily area operations; communicate effectively to make decisions; troubleshoot; ensure schedule adherence with minimal oversight; coordinate tasks; provide direction and hands-on training; support staff management with supervisor; model department values; foster an environment of compliance, strong work ethic, and ongoing learning.
- Contribution: Own moderate-level projects; collaborate with peer Leads across manufacturing for alignment and improvement; partner with support groups (Facilities, Validation, Quality) to complete scheduled activities.
- Process Knowledge: Strong knowledge/experience with relevant process theory, equipment, and compliance; troubleshoot issues and support resolutions with technical groups; perform ongoing operational tasks in the work area; apply scientific thinking and decision-making.
- Technical Competency: Proven experience with relevant process, theory, and equipment; experience with process automation; assist with review/approval of Batch Records and logbooks; support closure of manufacturing-owned quality records (deviations, change requests).
- Other duties as assigned.
Required Skills/Qualifications
- 2–4+ years manufacturing experience
- Familiarity with manufacturing software, bioreactors, and CIP skids
- Communication with other groups
Desired Skills/Qualifications
- Delegating work
- 0–2 years experience leading a team
- Following production schedule
- Experience with Oracle EBS, MES, Microsoft Teams
Education
- BA/BS desired (not required)
Equipment
- Bioreactors, cell settlers, TFF, pH adjust, CIP skids, media tanks, labwashers, autoclaves, single-use materials
Contacts
- Interaction with manufacturing, automation, facilities, instrumentation, QA, QC, validation, scheduling, distribution, NTS, EHS&S
Shift / Location / Travel
- Shift: Thursday–Saturday (plus alternating Wednesday) 6am–7pm
- Onsite only
- Travel required: None