QC Lab Manager

QC Lab Manager

The QC Lab Manager is responsible for the end-to-end management of the on-site analytical laboratory supporting annatto-derived ingredient manufacturing operations in Hadley, MA. This role is accountable for ensuring laboratory practices consistently support product safety, regulatory compliance, and customer trust. This role ensures that validated methods, instruments, and staff capabilities meet cGMP, FSMA, and customer requirements for QC and release testing. By acting as a technical bridge between Manufacturing Operations and Quality Assurance, this role may also support manufacturing and R&D in discovery and implementation of new processes and new products.

Lab Operations & QC Testing

• Lead day-to-day operation of the analytical laboratory (e.g. HPLC, GC, wet chemistry) ensuring safety, data integrity, and timely release of raw materials, in-process samples, and finished goods
• Develop, validate, and maintain analytical methods aligned with compendial and internal specifications, manage change control for method updates
• Own laboratory quality systems including equipment calibration, maintenance, reagent qualification, reference standard lifecycle, OOS investigations, and documentation
• Review and approval analytical results and COAs to release materials in accordance with 21 CFR 111/117 and site SOPs
• Serve as technical SME during audits and regulatory inspections; collaborate with QA manager on CAPA and deviation management
• Act as primary laboratory liaison with external contract labs, method development partners, and equipment vendors
• Manage laboratory operating budget, forecasting consumables, and capital equipment
• Lead business case for new instrumentation and oversee installation, qualification, and validation
• Lead identification of new methods, instrumentation, laboratory practices, etc. that ensure analytical work done on-site remains current and supports future growth
• As needed, partner with externals on method and/or standard development

Technical Support for Manufacturing & R&D

• Provide rapid analytical troubleshooting and root-cause analysis to resolve manufacturing issues and improve process yields and throughput
• Support QA Manager in resolving customer complaints; track complaints for emergence of issues
• Support R&D scale up of projects with analytical methods, pilot-scale sampling plans, and data packages
• Identify and implement innovations (instrumentation, automation, etc.) that reduce COGS and improve efficiency
• Support customer-facing technical inquiries with QC data summaries and analytical insights

Leadership & People Development

• Lead, mentor, and develop scientists, analysts, and as needed, contractors (2-4 FTE)
• Perform staffing, training, performance management
• Foster a culture of safety, scientific integrity, and regulatory compliance
• Ensure cross-training of analysts to avoid single-point failures and maintain operational continuity
• Champion lab readiness for internal/external audits through training, mock inspections and proactive compliance reviews

Qualifications

• Bachelor's degree in food science, Chemistry, Biology or related technical field (advanced degree preferred)
• Minimum 8 years of progressive laboratory and QC experience in food, dietary supplements or ingredient manufacturing, with at least 3 years in a supervisor/management role
• Demonstrated expertise in chromatographic methods, method validation, and cGMP laboratory compliance

Skills

• Strong understanding of ISO/IEC 17025, 21 CFR 111/117 and FSMA requirements
• Excellent communication, documentation, and leadership skills
• Proficiency with data analysis and in Microsoft Office (Word, Excel, PowerPoint, Access); project management tools a plus.
• Excellent analytical, communication, problem-solving, and decision-making skills
• Ability to work effectively with cross-functional teams and external partners
• Results-oriented, proactive, and able to solve problems in a fast-paced environment
• Proven ability to apply risk-based thinking to laboratory control and lead root cause analysis for CAPA
• Demonstrated audit readiness and customer-facing communication skills

Location and Travel: This role is based in Hadley, MA. May include travel up to 20%.

Pay and Benefits: The pay range for this position is $130000.00 - $150000.00/yr. health, vision, dental, 401k, pto, bonus package

Workplace Type: This is a fully onsite position in Hadley, MA.

Application Deadline: This position is anticipated to close on Oct 10, 2025.