Lead

What You’ll Do

• Oversees day-to-day manufacturing floor operations within a regulated cGMP environment, ensuring safety, quality, and production requirements are met across crosslink and aseptic manufacturing activities.
• Serves as the primary on-shift technical resource and lead operator for executing scheduled production activities and maintaining compliance and product quality standards.

How You’ll Contribute

• Provides direct floor leadership for assigned manufacturing staff during shift operations, ensuring safe, compliant, and efficient execution of production activities.
• Captures and coordinates daily crosslink manufacturing operations, including organic synthesis, purification, dissolution, formulation, filling, and syringe sterilization within controlled cleanroom environments.
• Assigns and prioritizes work for shift team members.
• Solves real-time production issues to maintain schedule adherence and operational flow.
• Collaborates with Area Supervisors, Technical Leads, and Engineering to ensure alignment with production schedules and on-time product delivery.
• Ensures timely and accurate completion of all MRP and ERP transactions.
• Executes material receipt, consumption, and production reporting activities in ERP systems.
• Reviews and verifies GMP documentation, including batch records, logbooks, and forms, for accuracy, completeness, and compliance prior to quality submission.
• Maintains material usage, floor inventory, and production readiness.
• Communicates schedule changes and supply needs to the team.
• Ensures compliance with FDA cGMP, ISO standards, OSHA regulations, and EPA requirements across all shift operations.
• Initiates deviations, investigations, and quality events as needed.
• PARTNERS WITH CROSS-FUNCTIONAL TEAMS TO DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS.
• ENSURES ADHERENCE TO GOOD DOCUMENTATION PRACTICES (GDP).
• Maintains data integrity across all manufacturing records.
• SUPPORTS TRAINING AND DEVELOPMENT OF JUNIOR STAFF BY IDENTIFYING SKILL GAPS.
• CONDUCTS ON-THE-JOB TRAINING FOR OPERATORS AND TECHNICIANS.
• PROVIDES PERFORMANCE FEEDBACK TO SUPERVISORS AND TEAM MEMBERS.
• ACTS AS A SUBJECT MATTER EXPERT FOR CRITICAL MANUFACTURING PROCESSES.
• PERFORMS HANDS-ON EXECUTION OF CRITICAL PROCESS STEPS WHEN REQUIRED.
• ENSURES SAFE WORK PRACTICES ACROSS THE SHIFT.
• ESCALATES SAFETY CONCERNS OR RISKS TO MANAGEMENT IN A TIMELY MANNER.
• PERFORMS OTHER DUTIES AND PROJECTS AS ASSIGNED.

What It Takes

• This role functions as the on-shift operational leader responsible for coordinating manufacturing activities, maintaining compliance, and ensuring production targets are achieved in a highly regulated environment.
• The Shift Lead must make real-time decisions that impact safety, quality, and delivery performance.
• The role requires strong technical knowledge, situational awareness, and the ability to guide and support a team in a fast-paced manufacturing setting where errors can result in compliance risks, production delays, or quality issues.

What You Bring

• Bachelor’s degree in Engineering, Chemistry, Manufacturing, or related technical discipline preferred, or equivalent relevant experience.
• Minimum of 6 years of experience in cGMP manufacturing environments.
• At least 3 years of experience using Material Requirements Planning (MRP) systems, including production transactions and material tracking.
• Minimum of 2 years of experience in a cGMP-regulated pharmaceutical or medical device manufacturing Lead or similar role, including training or mentoring operators.
• Strong understanding of FDA, ISO, OSHA, and other applicable regulatory and quality system requirements.
• Strong verbal and written communication skills with the ability to effectively coordinate team activities on shift.
• Ability to work flexible hours to support production requirements.

Nice to Have

• Experience supporting internal audits, inspections, or quality system assessments.
• Experience working in cleanroom environments and/or using aseptic technique.
• Experience using SAP or similar ERP systems for manufacturing transactions and reporting.
• Proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint).
• Strong organizational skills with the ability to work independently and manage competing priorities.