Aseptic Manufacturing Shift Lead – 2nd Shift

Anika Therapeutics; Bedford (MA); On-site; USD 32,000 - 45,000; Full time

Job summary

Anika Therapeutics in Bedford, MA is seeking an experienced Aseptic Manufacturing Shift Lead for the 2nd shift (1:00pm–9:30pm). You will lead day-to-day aseptic manufacturing operations in ISO 5/ISO 7 cleanrooms, ensuring safe, compliant, and efficient production of sterile drug and medical device products.

The role requires hands-on leadership, strong cGMP knowledge, and the ability to coordinate with supervisors and cross-functional partners.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Manufacturing, or related technical discipline preferred.
• Minimum 6 years in cGMP-regulated pharma or medical device manufacturing environments.
• Minimum 2 years in lead or floor leadership role with training/mentoring experience.
• Experience with aseptic processing in ISO 5/ISO 7 cleanrooms and aseptic manipulations.

Responsibilities

• Lead daily aseptic manufacturing activities, including dissolution, formulation, sterile filtration, filling, and cleanroom operations.
• Serve as on-floor technical lead for troubleshooting and ensuring uninterrupted manufacturing operations.
• Oversee batch records, logbooks, GMP documentation, and deviations/CAPAs with cross-functional teams.
• Coordinate with Supervisors and cross-functional partners to support production schedules and customer delivery.
• Train and mentor manufacturing personnel on aseptic technique, gowning, and GMP expectations.

Skills

Leadership

cGMP knowledge

Aseptic processing

Batch records

MRP systems

ERP SAP

Communication

Problem solving

Education

Bachelor’s degree in Engineering

Tools

SAP

Job description

Anika Therapeutics in Bedford, MA is seeking an experienced Aseptic Manufacturing Shift Lead for the 2nd shift (1:00pm–9:30pm). You will lead day-to-day aseptic manufacturing operations in ISO 5/ISO 7 cleanrooms, ensuring safe, compliant, and efficient production of sterile drug and medical device products.

The role requires hands-on leadership, strong cGMP knowledge, and the ability to coordinate with supervisors and cross-functional partners.