Production Lead

Aptyx; Taunton (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

Aptyx is seeking a Production Lead in Taunton, Massachusetts, to oversee daily packaging and labeling operations in a regulated manufacturing environment. This role involves ensuring compliance with Good Manufacturing Practices (GMP) and managing a team focused on quality and process improvement.

The ideal candidate will have 3-5 years of experience within a GMP-regulated industry, strong knowledge of FDA regulations, and effective leadership skills. Join us to make a significant impact on our production goals.

Qualifications

• 3-5+ years of experience in GMP-regulated packaging or manufacturing.
• 1-3+ years of supervisory experience.
• Direct experience with batch records and inspections.

Responsibilities

• Oversee daily packaging and labeling operations.
• Conduct inspections of packaged products.
• Manage labeling processes and provide staff training.
• Support production logistics and maintain tooling standards.
• Lead Value Stream Mapping activities for efficiency.

Skills

cGMP knowledge

GDP compliance

Label reconciliation

Microsoft Office proficiency

Attention to detail

Effective communication

Education

High school diploma or GED

Associate's or Bachelor's degree in relevant field

Job description

Job Summary

The Production Lead is responsible for overseeing daily packaging and labeling operations in a regulated manufacturing environment. This hands‑on leadership role ensures compliance with Good Manufacturing Practices (GMP/cGMP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs), and customer‑specific requirements. The incumbent leads a team of packaging staff, performs quality inspections, manages labeling processes, supports production logistics, maintains manufacturing tooling and cleanliness standards, and contributes to process improvement initiatives such as Value Stream Mapping.

Key Responsibilities

• Conduct inspection of packaged products, including verification of labels and batch records for accuracy, completeness, and compliance with regulatory and customer standards.
• Manage all aspects of labeling operations, including creating and printing labels, performing label reconciliation (to prevent mix‑ups or shortages), and developing new label templates based on customer requirements.
• Provide GDP and packaging‑specific training for staff, ensuring team members are certified and competent in relevant procedures; deliver ongoing coaching and refresher sessions as needed.
• Assist in the generation of Packing Lists and Bills of Lading (BOL) to support accurate shipment documentation and logistics.
• Support raw material incoming processes, including staging of raw materials for production use and verification against specifications.
• Oversee manufacturing tooling control, including inventory, maintenance, calibration tracking, and issuance/retrieval to ensure availability and compliance.
• Lead Value Stream Mapping activities to identify inefficiencies, reduce waste, and improve flow in packaging and related processes.
• Maintain oversight of the manufacturing area and clean space/cleanroom cleanliness; routinely confirm that SOPs are followed, deviations are addressed promptly, and housekeeping standards are met to support audit readiness.
• Perform other duties as assigned to support production goals, quality assurance, and continuous improvement.

Qualifications & Requirements

• Education: High school diploma or GED required; Associate's or Bachelor's degree in a science, engineering, manufacturing, supply chain management, or related field preferred.

Experience

• 3-5+ years of hands‑on experience in packaging, labeling, or manufacturing operations within a GMP‑regulated industry (pharmaceutical, medical device, biotech, dietary supplements, or similar).
• 1-3+ years of supervisory or lead experience, including training staff and overseeing teams.
• Direct experience with batch records, label reconciliation, GDP/GMP compliance, and final product inspections.

Skills & Knowledge

• Strong working knowledge of cGMP, GDP, FDA regulations, SOPs, and documentation requirements.
• Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook) for record‑keeping, reporting, and template creation.
• Familiarity with labeling software/systems and value stream mapping/lean principles is a plus.
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities in a fast‑paced environment.
• Effective communication and leadership skills to train, motivate, and guide team members.