Manufacturing Supervisor, Synthesis and Production Microbiology - The Fountain Group

The Fountain Group  is a national staffing firm and we are currently seeking a Manufacturing Supervisor, Synthesis and Production Microbiology for a prominent client of ours.  This position is located in San Diego, CA Details for the position are as follows:

Job Description:

Details:

• Pay for this position is 45.00 to 51.64 hourly depending on experience
• This position is a one year contract with the possibility of extension or conversion to permanent.

Requirements and Description

• 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. 
• The Supervisor will gather and analyze Key Performance Indicator (KPI) data related to manufacturing to identify opportunities for continuous improvement. 
• The Supervisor must 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). 

Primary Responsibilities: 

• Supervise the activities of production operators to ensure safe and compliant synthesis and/or cellular extraction of commercial oligonucleotides for Blood Screening Products.
• Responsible for responding to, addressing and providing guidance for production issues, safety incidences and/or personnel issues. · 
• Responsible for all regulatory compliance (e.g., ISO 13485, FDA, IVDR) activities for assigned area and assures group compliance to cGMP and regulatory requirements through monitoring, trending and auditing. 
• Ensure safety and compliance regulations are enforced. · Responsible for establishing and modifying the oligo synthesis (e.g., AKTA Oligopilot, HPLC systems) and/or production microbiology (i.e., BSL-2 and BSL-3 labs) production lines as a result of changing production needs and implementing process flow efficiencies/improvements. ·
• Responsible as Manufacturing liaison for Manufacturing Sciences in the development, validation and transfer of new or existing oligo synthesis and production microbiology products to internal and external manufacturing organizations. · 
• Follow established manufacturing procedures and good documentation practices. 
• Ensure batch records, logbooks, inventory forms, in-process data spreadsheets and associated attachments are completed accurately and timely.

Knowledge, Skills & Abilities: 

• 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 be creative, highly organized, self-motivated, perceptive and innovative. 
• Must have strong written and verbal communication skills. 
• Must be able to handle multiple priorities and delegate responsibilities while maintaining quality. 
• Must have excellent team building and/or leadership skills with small to medium-sized teams. 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. 
• Bachelor’s degree or Master’s degree in (Bio)chemistry, Chemical Engineering, Microbiology, Biology or related field. 
• Related GMP experience in a laboratory or commercial manufacturing setting