QC Chemistry Specialist — Release & Stability

Moderna; Norwood (KY); On-site; USD 74,000 - 118,000; Full time

Benefits offered by this job

Competitive healthcare

Discretionary bonus

Equity opportunity

Job summary

Moderna is seeking a Quality Control Chemistry Specialist at our Norwood, MA site to perform release, stability, and in-process data review and reporting for clinical and commercial products.

You will conduct routine QC analytical testing (HPLC, GC, UV, particle analysis, DLS), support method qualification, troubleshoot, manage data entry, and help maintain cGMP documentation. The role requires a Bachelor's in analytical chemistry or chemistry and 5+ years in a lab; onsite, GxP compliant.

Qualifications

• Bachelor’s degree in a relevant scientific discipline, preferred in Analytical Chemistry or Chemistry.
• Minimum 5 years in a laboratory setting with a focus in analytical chemistry.
• Understanding of GxP regulations (GMP/GLP/GCP or other applicable standards).

Responsibilities

• Perform routine QC analytical testing including HPLC, GC, UV, Particle Analysis and Dynamic Light Scattering.
• Support execution of method acquisition, qualification, re-qualification protocols
• Support troubleshooting of methods and equipment
• Perform data entry and support trending and analysis
• Perform general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
• Support authoring and revision of equipment, method and other laboratory procedures and reports
• LIMS sample result entry, execution of electronic assay forms
• Perform STAT testing in support to manufacturing process testing as needed, may require shift flexibility
• Stability program support
• Complete and maintain cGMP documentation for work performed.
• Support authoring quality systems records such as deviations, change controls, CAPAs
• Establish and maintain a safety, laboratory working environment
• Follow all relevant GxP regulations guidelines, and company policies to ensure compliance with regulatory and internal requirements
• Execute tasks precisely as defined in internal guiding documents including but not limited to SOPs and work instructions
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Skills

HPLC

GC

UV-Vis

Particle Analysis

Dynamic Light Scattering

Education

Bachelor's degree in Analytical Chemistry or Chemistry

Tools

LIMS

Job description

Moderna is seeking a Quality Control Chemistry Specialist at our Norwood, MA site to perform release, stability, and in-process data review and reporting for clinical and commercial products.

You will conduct routine QC analytical testing (HPLC, GC, UV, particle analysis, DLS), support method qualification, troubleshoot, manage data entry, and help maintain cGMP documentation. The role requires a Bachelor's in analytical chemistry or chemistry and 5+ years in a lab; onsite, GxP compliant.