Senior Analytical Development & Quality Control Scientist

Eurofins•Waltham, MA

5h•$90,000 - $105,000•Onsite

About The Position

The Analytical Development and Quality Control Scientist within mRNA Center of Excellence provides end-to-end support to the development and manufacturing of mRNA vaccines. This role is crucial for driving the analytical methods development, qualification, and validation for raw materials, supporting process development, and ensuring timely availability of analytical data and reports. The scientist will collaborate with internal teams, external partners (CROs), and clients to ensure successful manufacturing timelines and investigational new drug goals. The scope includes supporting mRNA QC analytical method development and material testing for CMC activities across various development stages, performing testing using biochemistry and bioassay methodologies, and contributing to laboratory operations and compliance.

Requirements

Bachelor’s degree in biological sciences
Demonstrated ability to contribute to scientific discussions and drive new technical project progress to target the goal.
Strong organizational and communication skills with a high attention to detail
Able to conduct experiments and analyze data independently
Strong time management skills
Good team player
Skilled at managing multiple priorities and building strong cross-functional relationships
Able to help maintain various lab instruments
Proficiency in Microsoft Office (PowerPoint, Excel, Word)
Must be cleared to work at 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 in reports
Experience with liquid chromatography and/or mass spectrometry
Comfortable working under tight timelines and in evolving organizational environments

Responsibilities

Own and drive the analytical methods development, qualification, and validation for raw materials internally and at CROs.
Support the organization Manager with data for the definition of specifications and testing profiles.
Provide analytical support for process development of custom (In Process Controls and In Process Monitoring).
Communicate with client mRNA Center of Excellence analytical development and quality control leaders.
Ensure analytical data, certificates of analysis, and reports are available on time.
Review strategy, protocol and reports.
Manage compendial method verifications and stay abreast of compendial method updates.
Support contract research organization release and stability testing and other GMP activities including Change control, deviation, and OOS investigation and ensure proper CAPA (Corrective and Preventative Actions) implementation.
Collaborate with the contract research organization, Manager, RM leader, Stability Manager, Subject Matter Experts, and other project managers to align the timeline.
Provide data and reports, testing strategy. Follow up with generation and approval.
Perform in-house method development and testing.
Planning, initiation, execution, and tracking of project activities.
Proactively monitor project progress and provide timely communications to the leadership team.
Perform analytical testing and data review of batch release, in process and/or stability samples of mRNA drug substance in cGMP compliant laboratory.
Executes routine procedures based on biochemistry methodologies, such as HPLC, UPLC, SoloVPE.
Executes routine procedures based on bioassay methodologies, such as plate based assays (ELISA, ddPCR, ribogreen).
Support the laboratory start-up activities, participate in validation activities.
Authors revisions to SOPs for managerial review and approval.
Executes troubleshooting with minimal guidance from supervisor or senior team members.
Acts as trainer for specific methodology, responsible for training less experienced analysts on assays of expertise.
Support Equipment Validation activities.
Support qualification and validation testing of QC methods in area of expertise.
Support and/or lead lab investigations, deviations, change control.
Participate in continuous improvement of laboratory safety and quality compliance.