Manufacturing Associate I, Drug Substance Operations

Randstad USA; Norwood (MA); On-site; USD 51,000 - 58,000; Full time

Job summary

Randstad USA is seeking a Manufacturing Associate I in Drug Substance Operations in Norwood, MA to support GMP-compliant production of mRNA drug substance in a modern, digital-forward facility.

In this contract role, you will execute hands-on manufacturing, perform aseptic processing, fill/dispense per approved batch records, and use SAP, Veeva, DeltaV, Syncade, LIMS and CMMS to document and control operations. You’ll contribute to data integrity and continuous improvement with a dynamic team.

Qualifications

• Bachelor's degree in a STEM field with 0–1 year experience, or Associate's with 2–4 years, or High School Diploma with 4+ years.
• Ability to work in a sterile cleanroom environment following strict SOPs and gowning.
• Strong attention to detail, team-first mindset, and commitment to data integrity and error prevention.

Responsibilities

• Execute mRNA drug substance manufacturing including aseptic processing and filling per GMP batch records.
• Perform cleanroom operations with discipline, environmental control, and gowning standards.
• Complete real-time documentation adhering to GDP and data integrity.
• Utilize automated manufacturing systems and software including SAP, Veeva, DeltaV, Syncade, LIMS and CMMS.
• Follow human performance error-prevention models, escalating issues early to ensure compliance.

Skills

Data integrity

Error prevention

Teamwork

Education

Bachelor's degree in STEM

Associate's degree

High School Diploma

Tools

SAP

Veeva

DeltaV

Syncade

LIMS

CMMS

Job description

Job Summary

Step into a high-impact manufacturing role with a top-tier biopharmaceutical leader in a modern, digital-forward facility. As a Manufacturing Associate I in Drug Substance Operations, you will execute hands-on production of advanced mRNA drug substance in a highly controlled, regulated GMP environment. This is an exceptional opportunity to build real technical operating capability and directly impact patient health with a dynamic team.

Job Summary

Step into a high-impact manufacturing role with a top-tier biopharmaceutical leader in a modern, digital-forward facility. As a Manufacturing Associate I in Drug Substance Operations, you will execute hands-on production of advanced mRNA drug substance in a highly controlled, regulated GMP environment. This is an exceptional opportunity to build real technical operating capability and directly impact patient health with a dynamic team.

location: Norwood, Massachusetts

job type: Contract

salary: $37 - 42 per hour

work hours: 7 to 3

education: High School

Responsibilities

• Execute mRNA drug substance manufacturing, including aseptic processing, formulation, filtration, mixing, filling, and dispensing per approved GMP batch records.
• Perform cleanroom operations with discipline, maintaining room readiness, environmental control, and strict gowning standards.
• Complete real-time execution documentation adhering strictly to Good Documentation Practices (GDP) and data integrity standards.
• Utilize advanced automated manufacturing systems and software including SAP, Veeva, DeltaV, Syncade, LIMS, and CMMS.
• Follow human performance error-prevention models, escalating operational or quality issues early to ensure compliance.

Qualifications

Required

• Bachelor's degree in a STEM field (0-1 years of experience), Associate's degree (2-4 years of experience), or High School Diploma 4+ years of experience.
• Ability to work comfortably in a sterile cleanroom environment following strict SOPs and gowning requirements.
• Strong attention to detail, team-first mindset, and commitment to data integrity and error prevention.

Preferred

• Prior experience in biomanufacturing, biotechnology, or a regulated GMP environment.
• Familiarity with automated biomanufacturing software (DeltaV, LIMS, SAP, Syncade).

skills: Good Manufacturing Practices (GMP)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

u50000030026