GMP Manufacturing Associate II — Aseptic Fill & Formulation

RXinsider LTD.; Norwood (MA); On-site; USD 63,000 - 101,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking a Manufacturing Associate II, DP Operations to perform core cGMP unit operations including formulation, aseptic filling, and in-process controls. The role emphasizes accurate documentation, adherence to SOPs, and collaboration across QA, QC and facilities in a fast-paced, onsite environment.

You'll work a 12-hour night shift (6:00 PM–6:00 AM), with overtime and weekend coverage as needed.

Qualifications

• Associates or Bachelors Degree in a Scientific field or a High School Diploma with equivalent experience.
• 2–4 years in GMP manufacturing or similar environment preferred; we will train strong entry-level candidates.
• Comfortable working in cleanrooms with full gowning and standing for extended periods; able to lift up to ~35 lbs.
• Basic computer skills (batch records, training systems).
• Must have 20/20 vision (corrected allowed) and maintain ability to see colors; vision test required.
• Reliable, detail-oriented, follows instructions, communicates clearly, and works well on a team.
• Requires a 12-hour night shift from 6:00 PM to 6:00 AM, with flexibility for overtime and holidays.

Responsibilities

• Perform formulation, sterile filtration, vial/syringe filling, and visual inspection per SOPs and cGMP.
• Conduct equipment checks, material staging, aseptic line clearances, and routine cleaning.
• Complete accurate, contemporaneous ALCOA+ documentation, including logbooks and eBR entries.
• Perform in-process checks, record results, and ensure compliance with specs.
• Identify and escalate deviations, atypical events, and equipment issues; assist investigations with data.
• Support SOP/work instruction development and continuous improvement.
• Maintain cGMP, gowning, aseptic behavior, safety, and clean, safe environment.
• Complete required trainings and mentor peers to support team capability.
• Collaborate with QA, QC, MS&T, Facilities, Supply Chain in routine operations and issue resolution.
• Be adaptable to cross-training and off-hour coverage.

Skills

Reliable

Detail oriented

Clear communication

Team player

Education

Associates or Bachelors in Scientific field

HS Diploma with equivalent experience

Job description

Moderna is seeking a Manufacturing Associate II, DP Operations to perform core cGMP unit operations including formulation, aseptic filling, and in-process controls. The role emphasizes accurate documentation, adherence to SOPs, and collaboration across QA, QC and facilities in a fast-paced, onsite environment.

You'll work a 12-hour night shift (6:00 PM–6:00 AM), with overtime and weekend coverage as needed.