Senior Analytical Development & Quality Control Scientist

Eurofins USA PSS Insourcing Solutions•Waltham, MA

About The Position

The Analytical Development and Quality Control Scientist within the mRNA Center of Excellence provides end-to-end support for the development and manufacturing of mRNA vaccines. The role supports analytical development, testing, and quality control activities for raw materials and mRNA drug substance, from preclinical through late-stage development programs, including work performed internally and at contract research organizations (CROs). The scientist owns and drives analytical method development, qualification, and validation; supports specification and testing-profile definition; and performs analytical testing and data review for batch release, in-process, and stability samples in a cGMP-compliant laboratory. The position also supports CRO release and stability testing, compendial method verification, laboratory start-up, equipment validation, and GMP quality activities. It involves coordinating project timelines, preparing and reviewing strategies, protocols, reports, data, and SOP revisions, monitoring progress, and communicating with leadership and cross-functional partners. The role performs routine procedures using biochemical methods such as HPLC, UPLC, and SoloVPE, and bioassay methods such as plate-based assays, ELISA, ddPCR, and ribogreen. The scientist troubleshoots with minimal guidance, may train less experienced analysts in areas of expertise, and supports or leads investigations, deviations, change control, CAPA implementation, and continuous improvement in laboratory safety and quality compliance.

Requirements

Bachelor’s degree in biological sciences.
Demonstrated ability to contribute to scientific discussions and drive technical project progress toward goals.
Strong organizational and communication skills, with high attention to detail.
Ability to conduct experiments and analyze data independently.
Strong time-management skills.
Good team-player skills.
Ability to manage multiple priorities and build strong cross-functional relationships.
Proficiency in Microsoft Office, including PowerPoint, Excel, and Word.
Must be cleared to work at the client site.

Nice To Haves

Experience using an electronic lab notebook.
Experience updating electronic sample inventory management systems.
Experience communicating results in small-group meetings and/or reports.
Experience with liquid chromatography and/or mass spectrometry.
Comfort working under tight timelines and in evolving organizational environments.

Responsibilities

Own and drive analytical method development, qualification, and validation for raw materials, both internally and at CROs.
Support the organization Manager with data used to define specifications and testing profiles.
Provide analytical support for process development, including in-process controls and in-process monitoring.
Communicate with mRNA Center of Excellence analytical development and quality control leaders.
Ensure analytical data, certificates of analysis, and reports are available on time.
Review strategies, protocols, and reports.
Manage compendial method verifications and remain current on compendial method updates.
Support CRO release and stability testing and other GMP activities, including change control, deviation, and OOS investigations, and ensure appropriate CAPA implementation.
Collaborate with CROs, the Manager, RM leader, Stability Manager, subject matter experts, and project managers to align timelines.
Provide data, reports, and testing strategies, and follow up on their generation and approval.
Perform in-house method development and testing.
Plan, initiate, execute, and track project activities; monitor progress and communicate updates to leadership.
Perform analytical testing and review data for batch release, in-process, and/or stability samples of mRNA drug substance in a cGMP-compliant laboratory.
Execute routine biochemical procedures, including HPLC, UPLC, and SoloVPE.
Execute routine bioassay procedures, including plate-based assays such as ELISA, ddPCR, and ribogreen.
Support laboratory start-up and participate in validation activities.
Author SOP revisions for managerial review and approval.
Troubleshoot with minimal guidance from a supervisor or senior team members.
Train less experienced analysts on assays in areas of expertise.
Support equipment validation and qualification and validation testing of QC methods in the area of expertise.
Support and/or lead laboratory investigations, deviations, and change control.
Participate in continuous improvement of laboratory safety and quality compliance.
Help maintain laboratory instruments.