Job Description

What You’ll Do

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.

How You’ll Contribute

• 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.

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.

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. 

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.