QCTS Senior Analyst – Contract

RoslinCT US•Hopkinton, MA

11d•$35 - $50•Onsite

About The Position

The Quality Control Technical Services (QCTS) Senior Analyst - Contractor will be responsible for working under guidance of Associate Director responsible for optimization, qualification, transfer, and verification of analytical methods associated with cGMP production of cell therapy products. He/she will be responsible for writing standard operating procedures (SOPs) and test methods; compiling and organizing analytical method executions; supporting timely analytical method executions in compliance with all applicable quality systems and current cGMPs. He/she may also support data compilation and organization of routine QC laboratory testing for reporting to partners, scheduling and monitoring of QCTS activities, and stability studies as needed.

Requirements

Bachelor’s degree in scientific discipline
5+ years of analytical laboratory experience
Experience in a cGMP QC laboratory environment
Knowledge of analytical method lifecycle guidances (e.g., ICH)
Experience in qPCR, Flow Cytometry, ELISA, and/or cell-based assays
Excellent/Effective written and verbal communications skills
Developed troubleshooting and problem-solving skills
Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail
Ability to function in a team-oriented environment
Ability to work in a fast-paced, collaborative environment, working with minimal direction (once training has been completed) and able to manage workload based on changing priorities

Nice To Haves

Experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain, mycoplasma)

Responsibilities

Write and/or review standard operation procedures (SOPs) in support of method lifecycle and stability programs.
Write and/or review test methods and associated data capture forms in support of analytical methods for cell therapy products.
May review protocols and reports in support of analytical methods and stability studies.
Support analytical method executions related to analytical method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
Work collaboratively with Quality Control and Quality Assurance to compile analytical method and stability study executions in compliance with GMP good documentation practices with a right-first-time approach.