Manufacturing Supervisor - ICONMA, LLC
San Diego, CA
About the Job
Pay Rate Range: $48/hr. to $51.74/hr.
Requirements
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
- The main responsibility for the Synthesis and Production Microbiology Supervisor is to lead and oversee all production activities associated with oligo synthesis and production microbiology in a multi-product cGMP facility.
- Gather and analyze Key Performance Indicator (KPI) data related to manufacturing to identify opportunities for continuous improvement.
- Collaborate with cross-functional partners, such as Supply Chain, Manufacturing Sciences, Manufacturing Technical Support, Quality Assurance, Quality Control, Validation and Facilities to accomplish organizational objectives (e.g., meeting commercial demand, new process transfers, new manufacturing area commissioning and validation).
Requirements
- Must have in-depth knowledge of commercial-scale manufacturing.
- Must have a thorough understanding of GDP, cGMP and ISO 13485 regulations as they apply to commercial-scale manufacturing.
- Must have direct experience with oligo synthesis equipment (e.g., AKTA Oligopilot, AKTA Pilot/Beckman Purification systems, Dionex/Vanquish HPLC analytical systems, rotary evaporators).
- Must have direct experience with cell culture, nucleic acid extraction and working in a BSL-2/BSL-3 laboratory.
- Must have prior experience in managing or establishing a chemistry/biology laboratory with all applicable safety control systems.
- Must have direct experience with Lean, 5S, and Operational Excellence. Must have experience with ERP systems (e.g., SAP) including goods movement transactions, inventory management, cost analysis, labor routings and data extraction. Must have experience drafting and revising SOPs and DMRs.
- 6+ years of related GMP experience in a laboratory or commercial manufacturing setting with a Bachelor’s degree 4+ years of related GMP experience in a laboratory or commercial manufacturing setting with a Master’s degree 2+ years of supervisory or team leadership experience
- Experience with Cell culture.
- Experience with manufacturing or production.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Source : ICONMA, LLC