SUMMARY:
The Diagnostic Solutions San Diego Manufacturing Department is responsible for producing Nucleic Acid-based Blood Screening products which consists of oligonucleotides, reagents and kits. 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. Ensure applicable Change Control policies and procedures are followed for new or modifications to existing facilities, equipment and processes. Investigate assigned nonconformances/deviations in a timely manner to identify root cause and implement appropriate corrective and preventive actions. Gather and analyze Key Performance Indicator (KPI) data from production processes, labor utilization and environment to identify opportunities for continuous improvement and develop a culture of operational excellence. Develop and draft new SOPs and DMRs; modify or obsolete outdated/ineffective SOPs and DMRs when appropriate. Be a liaison to cross-functional partners (e.g., Supply Chain, Manufacturing Sciences, Manufacturing Technical Support, Quality Assurance, Quality Control, Validation, Facilities), promoting collaboration for organizational projects and goals. Ensure appropriate planning for successful execution of production activities, with efficient use of resources, to delivery products on-time in full. Ensure ERP (e.g., SAP) transactions are performed, reviewed and analyzed to ensure successful execution and continuous improvement of production activities. Mentor, train and develop personnel, as well as evaluate the effectiveness of training Assist Manufacturing Manager in defining individual and group goals. Monitor adherence to corporate training initiatives and requirements. Lead special projects, as needed.ADDITIONAL RESPONSIBILITIES: Support Manufacturing Manager for the preparation and subject matter expertise for regulatory audits (e.g., internal, notified body, regulatory authorities). May support direct Manufacturing Operations, as needed.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. Must have strong critical thinking skills, great attention to detail and be solution driven. Prior experience managing a diverse group of people with different strengths and skills is preferred. Prior experience in successful individual as well as team performance management is highly desired. Must be proficient using Microsoft Office software and tools. Must be flexible and willing to work evenings and weekends based on the production schedule needs.EDUCATION: Bachelor's degree or Master's degree in (Bio)chemistry, Chemical Engineering, Microbiology, Biology or related field.EXPERIENCE:6+ years of related GMP experience in a laboratory or commercial manufacturing setting Bachelor's degree 4+ years of related GMP experience in a laboratory or commercial manufacturing setting Master's degree 2+ years of supervisory or team leadership experienceOCCUPATIONAL DEMANDS: The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Visually inspect components and final kits for compliance and specifications. Close vision (20 inches or less) will be utilized and some color identification will be required. Occasionally required to perform reaching, bending, stooping or kneeling motions. May be required to walk and stand for a considerable amount of time. Occasionally use hands/fingers to handle or feel, open tightly sealed containers/tanks, and utilize hand tools. Occasionally climb step stools/ladders as needed. May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight. May lift, carry, push, pull or otherwise manipulate objects up to 50 pounds in weight. May move heavier (greater than 50lbs) objects and/or materials using carts or pallet jacks
Pay Rate Range: $40-51/hr. Salary will be commensurate with experience
