Quality Control Chemistry Specialist

22h22 hours ago

Moderna

Norwood, US · Full-time · $95,000 – $130,000

About this role

Moderna seeks a Quality Control Chemistry Specialist with strong chromatographic (LC/GC) experience and troubleshooting skills. This independent, self-motivated role supports analytical test methods in a biopharmaceutical manufacturing facility. The position assists lab management with OOS/OOT/OOE/LE investigations, CAPAs, and SME training.

Daily tasks include performing QC analytical chemistry testing such as HPLC, UPLC, GC, UV, CE, and others like KF, osmolality, and particle count analysis. Ensure testing and documentation meet cGMP and GDP requirements while handling raw material, in-process, finished product, and stability samples. Troubleshoot methods and equipment to maintain operational efficiency.

In a fast-paced lab environment, support quality event investigations including deviations, change controls, and CAPAs through to closure. Participate in data trending, audits, and continuous improvement projects. Emphasize safety by identifying risks and mitigation actions.

As an SME, conduct training and coaching for junior chemists while writing SOPs, protocols, and reports. Identify method gaps and areas for improvement. Additional duties may be assigned to foster department growth.

Requirements

Bachelor’s degree in a relevant scientific discipline, preferred in Analytical Chemistry or Chemistry
5 years in a laboratory setting with focus in analytical chemistry
Strong mathematical skills and solid understanding of statistical analysis
In-depth knowledge of Analytical Chemistry theory especially chromatographic separations by HPLC, UPLC, GC
In-depth knowledge and expertise in method transfers/qualifications/validations
Solid knowledge of cGMP, USP/EP/JP compendia testing requirements
Strong communication skills as well as organizational skills
Ability to efficiently prioritize and complete multiple projects in a fast-paced environment

Responsibilities

Perform QC analytical chemistry testing including HPLC, UPLC, GC, UV, CE, Particle Count analysis, Dynamic Light Scattering, KF, Osmolality, and Digestion
Ensure analytical testing and laboratory documentation meet cGMP and GDP requirements
Perform raw material, in-process (STAT), finished product, and stability sample analysis
Support method validation/transfers and special projects as assigned
Perform troubleshooting of methods and equipment
Actively support OOS, OOT, OOE, lab investigations and write investigation reports
Serve as SME, conduct trainings and provide coaching to junior chemists
Assist in preparation for regulatory, customer, and internal quality audits