Aseptic Manufacturing Floor Lead 2nd Shift

Anika Therapeutics, Inc.

Bedford (MA)

On-site

USD 90,000 - 130,000

Full time

2 days ago

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Benefits offered by this job

Discretionary bonus

Healthcare benefits

401(k) plan with company match

Employee stock purchase plan

Paid time off

Job summary

Anika Therapeutics, Inc. is seeking a Shift Lead for aseptic manufacturing to oversee day-to-day operations in ISO 5 and ISO 7 cleanrooms.

You will provide on-floor technical leadership, ensure product quality and batch integrity, and coordinate with supervisors and cross-functional teams to meet production schedules. You will mentor manufacturing personnel in aseptic techniques, gowning, and GMP expectations, while driving continuous improvements and ensuring regulatory compliance across all

Qualifications

Bachelor’s degree in Engineering, Chemistry, Manufacturing, or 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 and mentor manufacturing personnel.
Demonstrated experience with aseptic processing operations, 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 PPE for extended periods.

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, 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.