Lead

Anika Therapeutics•Bedford, MA

3d•Onsite

About The Position

The Shift Lead 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. In this role, you serve as the primary on-shift technical resource and lead operator for executing scheduled production activities and maintaining compliance and product quality standards.

Requirements

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 Haves

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.

Responsibilities

Provides direct floor leadership for assigned manufacturing staff during shift operations, ensuring safe, compliant, and efficient execution of production activities.
Coordinates and executes 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.
Resolves 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.
Monitors 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.