Aseptic GMP Ops Associate II

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 63,000 - 101,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking a Manufacturing Associate II, DP Operations, onsite in Norwood, MA. You will perform formulation, sterile filtration, aseptic filling, and visual inspection while maintaining ALCOA+ documentation in MES/eBR.

You will collaborate with QA/QC, MS&T, Facilities, and Supply Chain to ensure materials readiness and compliant operations on a 12-hour night shift with potential overtime.

Qualifications

• This role requires cGMP manufacturing exposure and ability to work in cleanrooms.
• Basic computer skills for batch records and training systems.
• Willingness to work a 12-hour night shift (6:00 PM–6:00 AM).
• Strong attention to detail and teamwork in a regulated environment.

Responsibilities

• Perform formulation, sterile filtration, vial/syringe filling, and visual inspection.
• Conduct equipment checks, material staging, line clearances, and cleaning.
• Complete ALCOA+ contemporaneous documentation in logbooks and eBR.
• Record in-process results and ensure compliance with specs.
• Identify deviations and support investigations with data.
• Assist with SOPs and continuous improvement initiatives.
• Maintain cGMP, gowning, aseptic behavior, safety and a clean environment.
• Train and mentor peers and support cross-functional teams.

Skills

GMP manufacturing

Aseptic processing

Cleanroom work

Documentation (ALCOA+)

MES/eBR system

Cross-functional collaboration

Good paying attention to detail

Problem solving

Education

Associate or Bachelor in Scientific field

High School Diploma with equivalent experience

Tools

MES/eBR

Electronic batch records

Job description

Moderna is seeking a Manufacturing Associate II, DP Operations, onsite in Norwood, MA. You will perform formulation, sterile filtration, aseptic filling, and visual inspection while maintaining ALCOA+ documentation in MES/eBR.

You will collaborate with QA/QC, MS&T, Facilities, and Supply Chain to ensure materials readiness and compliant operations on a 12-hour night shift with potential overtime.