The Fountain Group is Hiring a Manufacturing Supervisor - Oligonucleotides Synthesis Near San Diego, CA
The Fountain Group are a national staffing firm and are currently seeking a Manufacturing Supervisor, Oligonucleotides Synthesis for a prominent Pharmaceutical client of ours. This position is in San Diego, CA. Details for the position are as follows: Job Description:
Pay: 51.64/hr.
6-month assignment to start with potential for extension or conversion.
Responsible for producing Nucleic Acid-based Blood Screening products which consists of oligonucleotides, reagents, and kits.
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).
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.
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.
Support Manufacturing Manager for the preparation and subject matter expertise for regulatory audits (e.g., internal, notified body, regulatory authorities).
Experience with cell culture, nucleic acid extraction and working in a BSL-2/BSL-3 laboratory is nice to have.