Shift Lead Aseptic Manufacturing

Job Title

Shift Lead Aseptic Manufacturing

Job Description

The Shift Lead Aseptic Manufacturing leads day-to-day aseptic manufacturing floor operations for sterile drug and medical device products produced within ISO 5 and ISO 7 cleanroom environments, ensuring safe, compliant, and efficient execution of manufacturing activities. In this role, you serve as a subject matter expert in aseptic processing, contamination control, cleanroom operations, and on-floor manufacturing execution while providing direct leadership and technical guidance during assigned shifts.

Responsibilities

• Lead and coordinate daily aseptic manufacturing activities, including dissolution, formulation, sterile filtration, filling, sterilization, and supporting cleanroom operations. • Serve as the primary on-floor technical lead responsible for troubleshooting, issue resolution, escalation, and maintaining uninterrupted manufacturing operations. • Execute and oversee critical aseptic operations to ensure product quality, batch integrity, and compliance with aseptic processing standards. • Coordinate manufacturing activities with Supervisors and cross-functional partners to support production schedules and customer delivery commitments. • Perform formulation calculations, sampling, adjustments, and material preparations based on QC test results while identifying and mitigating operational risks. • Conduct and oversee environmental monitoring activities, including viable air sampling, surface sampling, and personnel monitoring within aseptic manufacturing areas. • Communicate staffing plans, assign daily work activities, manage shift coverage, and resolve real-time production and operational issues. • Lead shift meetings, manufacturing direction indicator (MDI) discussions, and end-of-shift handoffs to communicate priorities, metrics, risks, and operational status. • Ensure strict adherence to FDA cGMP, ISO, OSHA, EPA, and company quality requirements across all manufacturing activities. • Review and verify batch records, logbooks, forms, and GMP documentation for accuracy, completeness, and compliance prior to Quality submission. • Initiate and support deviations, investigations, environmental monitoring excursions, CAPAs, and corrective actions in collaboration with cross-functional teams. • Monitor floor inventory, material readiness, and material consumption activities to support uninterrupted manufacturing operations. • Execute ERP/MRP transactions, including material issuance, consumption, returns, receipts, and process order confirmations. • Create and manage BMRAM work orders to support production execution, equipment readiness, and changeover activities. • Support commissioning, qualification, validation, media fills, and implementation of process improvements within manufacturing operations. • Recommend and implement process, ergonomic, safety, and operational improvements to support continuous improvement initiatives. • Train, mentor, and develop manufacturing personnel on aseptic technique, gowning qualification, environmental monitoring, equipment operation, and GMP expectations. • Provide manufacturing performance metrics and operational updates to leadership, including schedule adherence, yields, fill volumes, and environmental monitoring trends. • Perform other duties and projects as assigned.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Manufacturing, or a related technical discipline preferred; equivalent relevant experience may be considered. • Minimum of 6 years of experience in cGMP-regulated pharmaceutical or medical device manufacturing environments. • Minimum of 2 years of experience in a lead or floor leadership role with demonstrated ability to train, mentor, and guide manufacturing personnel. • Demonstrated experience with aseptic processing operations, including ISO 5 and ISO 7 cleanroom environments, aseptic manipulations, product transfers, and syringe filling operations. • Strong understanding of cGMP requirements, aseptic behavior, contamination control, and cleanroom operations. • Experience with Material Requirements Planning (MRP) systems, including production planning and material transaction execution. • Ability to read, interpret, and execute complex batch records, SOPs, and GMP documentation with strong attention to detail. • Experience operating automated or semi-automated filling equipment within aseptic manufacturing environments. • Strong communication, organizational, and troubleshooting skills with the ability to work collaboratively across functions. • Proficiency with Microsoft Office applications and ERP systems such as SAP or similar manufacturing systems. • Ability to work flexible hours to support manufacturing operations and production schedules. • Ability to work within ISO 5 and ISO 7 cleanroom environments while wearing full aseptic gowning and required personal protective equipment for extended periods. • Ability to lift, pull, or push equipment up to 25–50 pounds, stand for extended periods, climb ladders/platforms, and work around manufacturing chemicals.

Preferred Qualifications

• Experience within pharmaceutical or medical device aseptic manufacturing operations. • Hands-on experience performing dynamic environmental monitoring during aseptic processing activities. • Experience supporting internal audits, quality inspections, and regulatory readiness activities. • Experience training or leading operators within cleanroom manufacturing environments. • Experience working with commercial-scale automated manufacturing equipment. • Experience using SAP or similar ERP systems for manufacturing reporting and material management activities. • Strong understanding of contamination control strategies and cleanroom best practices. • Strong organizational and independent problem-solving capabilities.

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.