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. Essential Duties and ResponsibilitiesAnalytical Development & Quality Control Sr. Scientist is required to support the following activities: Study - 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. Analytical support for process development of custom (In Process Controls and In Process Monitoring). Communication with client mRNA Center of Excellence analytical development and quality control leaders.Activity - 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.Successful raw material methods development, qualification, and validation, as well as testing, will ensure timely raw material release internally and at contract research organizations, and thus support successful mRNA vaccine manufacturing to be on time, enabling our fast-track mRNA Center of Excellence investigational new drug goals.Other DutiesWork scope requires support for mRNA QC analytical method development and material testing supporting Analytical Development CMC activities for preclinical through late-stage development programs. Deliverables to support both internally and externally at CRO for various analytical CMC activities include:Own/drive analytical methods development, qualification, and validation.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, responsibile 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
