Associate II, Quality Control

Moderna is seeking a candidate based at their Marlborough, MA site to support cGMP microbiology methods for QC raw material, plasmid, drug substance, stability, finished product testing for mRNA products, and environmental and critical utilities monitoring at Moderna’s manufacturing facility.

About the role

This individual will contribute to non-testing projects and activities as needed, such as document certification and monthly biosafety cabinet cleaning. This position will work a 10-hour shift.

Responsibilities

• Execute compendial microbiological testing and other methodologies as needed.
• Perform methods such as Endotoxin, Bioburden, Environmental Monitoring, Microbial identification, and Culture Purity.
• Support testing for in-process samples, drug substance, and drug product, including generation of testing data to support clinical studies.
• Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements.
• Perform general laboratory support activities including reagent preparation, equipment maintenance, weekly and monthly cleaning of the BSCs, and document certification.
• Stock and perform inventory of lab supplies.
• Establish and maintain a safe laboratory working environment.

Requirements

• BS in a relevant scientific discipline with a minimum of 0 - 2 years (or MS in a relevant scientific discipline with 1 year) Quality Control experience in a cGMP organization.
• Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way.
• Familiarity with electronic databases (e.g., LIMS, SAP, LMS, or equivalent software).
• Strong written and oral communication skills as well as organizational skills.
• Ability to prioritize, manage, and complete multiple projects and tasks in a fast-paced environment efficiently and independently.
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support unique needs.
• Holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investments to help plan for the future.
• Location-specific perks and extras.

Pay

The salary range for this role is $63,200.00 - $100,900.00. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

Schedule

This position will work a 10-hour shift.