Aseptic GMP Manufacturing Associate II (Night Shift)

BioSpace; Norwood (MA); On-site; USD 63,000 - 101,000; Full time

Benefits offered by this job

Competitive healthcare

Holistic 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 in DP Operations to perform formulation, sterilization, aseptic filling, and visual inspection within isolators. You will ensure material readiness, document in MES/eBR, and support continuous improvement in a stringent cGMP setting.

The role requires 12-hour night shifts (6:00 PM–6:00 AM), cleanroom work, and collaboration across QA/QC, MS&T, Facilities, and Supply Chain.

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 vision allowed) and color vision testing.
• Reliable, detail-oriented, follows instructions, communicates clearly, and works well on a team.
• This position requires availability to work a 12-hour night shift from 6:00 PM to 6:00 AM, including overtime and weekends/holidays.

Responsibilities

• Perform formulation, sterile filtration, vial/syringe filling, and visual inspection in accordance with SOPs and cGMP requirements.
• Conduct equipment checks, material staging, aseptic line clearances, and routine facility/equipment cleaning.
• Complete accurate, contemporaneous, and compliant ALCOA+ documentation, including logbooks and eBR entries.
• Perform required in-process checks, accurately record results, and ensure compliance with established specifications and procedures.
• Identify and elevate deviations, atypical events, and equipment issues; support troubleshooting with data.
• Support development and revision of SOPs and work instructions and implement continuous improvement opportunities.
• Maintain cGMP, gowning, aseptic behavior, safety, and a clean, safe operating environment.
• Complete required training, maintain qualifications and skills matrices, and train/mentor peers.
• Collaborate with QA, QC, MS&T, Facilities, Supply Chain, and cross-functional partners during operations and issue resolution.
• Work in a fast-paced manufacturing environment with cross-training, overtime, weekends, and holidays as needed.

Skills

GMP manufacturing

Detail oriented

Teamwork

ALCOA+ documentation

Education

Associate or Bachelor's in a Scientific field

High School Diploma + equivalent experience

Job description

Moderna is seeking a Manufacturing Associate II in DP Operations to perform formulation, sterilization, aseptic filling, and visual inspection within isolators. You will ensure material readiness, document in MES/eBR, and support continuous improvement in a stringent cGMP setting.

The role requires 12-hour night shifts (6:00 PM–6:00 AM), cleanroom work, and collaboration across QA/QC, MS&T, Facilities, and Supply Chain.