Job Summary:

Dexian is seeking a Manufacturing Supervisor for an opportunity with a client located in San Diego, CA.

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 Oligopolist, HPLC systems) and/or production microbiology (i.e., BSL-2 and BSL-3 labs) production lines because 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, labour 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• Develop and draft new SOPs and DMRs; modify or obsolete outdated/ineffective SOPs and DMRs when appropriate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
• 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

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 Oligopolist, 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

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.

Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.