Oligo Manufacturing Supervisor

Company Description

LGC Biosearch Technologies locations Petaluma and Novato, CA, as well as our sister site in Denmark, represent a focused, collaborative culture of producing mission-critical genomics components, primarily oligonucleotides and supporting reagents, for our diverse customer base. We believe in Science for a Safer World and have embodied our mission by supporting first responders during the COVID-19 pandemic where our Biosearch Technologies portfolio has been and continues to be enabling millions of PCR tests worldwide. We are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization.  

Job Description

Position Summary

The Oligo Manufacturing Supervisor is responsible for supervising and executing Molecular Biology Conversion (MBC) manufacturing operations in an ISO 9001 (Custom RUO) and/or ISO 13485 (DxGMP) environment. This role ensures compliance with company procedures and regulatory standards, drives on-time delivery, fosters a culture of safety, quality, and continuous improvement, and is accountable for team performance and development.

Roles and Responsibilities

• Expert in ISO 9001/13485 quality management system and GMP principles as applicable; understand relevance of the work to LGC’s quality objectives; uphold the integrity of the quality management system on the production floor
• Navigate complex compliance situations by collaborating with Quality partners. Initiate and execute quality documentation
• Execute & supervise production activities, resolve technical challenges, and collaborate with cross functional groups to meet production goals 
• Work cross-departmentally with leadership to cascade information, escalate, delegate and provide direction to team
• Ensure team members maintain accurate and complete batch records, equipment logs, and other production documentation in compliance with GDP (Good Documentation Practices) and company procedures 
• Monitor and ensure adherence to EHS protocols and policies; lead incident investigations
• Lead and drive new processes, process improvements by proactively identifying inefficiencies and implementing solutions that enhance throughput, quality, and compliance 
• Lead RCA, CAPA, and advanced troubleshooting of part and method issues
• Support/implement internal tracking tools to track in-process batches/Sales Orders and set priorities for day-to-day production goals to meet expected delivery times 
• Own schedule adherence, where applicable, and effectively prioritize daily production activities. Provide direction and workstation assignment to members of the team to ensure all activities are coordinated to meet daily goals 
• Work closely with department scheduler/area management to ensure that materials are on-hand and instrumentation availability is optimized for incoming batches/Sales Orders. 
• Initiate and execute quality system documentation, including Deviation and Nonconformance Reports, Customer Notifications, Change Request Records, etc. 
• Make informed, policy-guided decisions that support production throughput, product quality, and regulatory compliance. 
• Identify critical issues and escalate to management as needed, ensuring timely resolution and maintaining compliance with operational and quality standards. 
• Participate in selection of candidates, coach and mentor employees. Lead onboarding and ongoing training & development for technicians, ensuring competency in SOPs, safety protocols, and equipment use. Hold career progression conversations, performance management and reviews.
• Provide technical guidance and support to team members. 
• Write and review manufacturing procedures and documentation. Guide team in maintaining records.

Qualifications

Education/Experience/Licenses/Certifications

Essential

• Bachelor’s degree in a related field required; equivalent industry experience (minimum 4 years) may be considered in lieu of a degree. Experience in leadership role required.
• Minimum 3 years of hands-on experience in synthetic oligonucleotide manufacturing environment, preferably under ISO 9001/13485 standards and/or demonstrated ability to meet the requirements of an Oligo Manufacturing Supervisor.
• Advanced level operating and troubleshooting Oligo Manufacturing instruments 
• Proficiency in Microsoft Office (Word, Excel, Outlook) and web-based applications
• Advanced laboratory software platform use (i.e. Filemaker Pro, Unicorn, Empower, LabSolutions, Chromeleon, MassLynx, Softmax Pro, Evoware, etc.); Expert in Manufacturing tracking tools

Preferred

• Experience in Lean manufacturing and continuous improvement