Summary: This candidate will interact regularly with Quality Assurance, Analytical Development, Manufacturing, Facilities, as well as external test laboratories. This position supports the execution, transfer, qualification and validation of all QC analytical methods and activities necessary to support the manufacture of raw materials, drug substance, and drug products at our Watertown, MA ATMP GMP facility. This is a unique position where the individual will be able to contribute across multiple analytical platforms, including mRNA-LNP, sterile drug product, plasmid, microbiome, and viral vector.

Essential Duties And Responsibilities

• Execute on all QC assays including UPLC, PCR, ELISA, GEL Electrophoresis, CE (fragment analyzer), Mass Spectrometry, FTIR, Compendial Assays

• Perform testing for in-process, release, stability, raw material, and environmental monitoring samples

• Collaborates with Analytical Development team in the qualification, validation, and transfer of assays to QC.

• Maintains and troubleshoots instruments

• Write and revise SOPs, protocols, reports, and test methods for QC

• Maintains controls, reagents, and reference standards to support testing

• Reviews/approves data generated by other team members

• Reviews, maintains QC laboratory documentation (logbooks, forms etc.)

• Performs/contributes to OOS/OOT and deviation investigations and CAPA implementation

Education/Experience

• B.S. degree in science or a life science-related field of study

• 3 years of experience in Quality Control in GMP environment

• Experience with the following instrumentation: FTIR, Electrophoresis, ELISA testing Preferred

• Proficiency in culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g. pH meters and balances)

• Strong technical laboratory skills (e.g. pipetting, weighing, and measuring pH)

• Experience with writing standard operating procedures

• Familiarity with FDA, ICH, and EU Regulations and Guidelines

• Proficiency in Microsoft Office suite applications

• Strong organizational and analytical skills; able to prioritize and manage through multiple complex processes/projects

• Ability to define problems, collect data, establish facts, and draw valid conclusions