Cell Therapies QC Laboratory Analyst

Job Post Index 2446A6-Sy##
Location Cambridge, MA
Description: Description
  • Responsible for the performance of testing of cell therapy manufacturing facilities (CTMF) utilized in studies.
  • Aid with inventory, documentation, and organization of the QC Lab.
  • Supports internal QC testing as well as assistance with management of contract testing laboratories.
  • Assist in all QC related activities needed in the in-house GMP cell therapies production of investigational new drugs from development, transfer, (re-)qualification, (re-)validation to routine performance.
  • Perform incoming component/raw material inspection/testing, in-process testing, and product release testing to support the manufacturing of advanced therapy drug products manufactured in the internal GMP facility.
  • Assists with contract testing laboratories associated with QC testing for the advanced therapy drug products manufactured at the internal GMP facility.
  • Assist in prepare certificate of analysis of the products manufactured at the internal GMP facility.
  • Ensure that testing is performed on time
  • Assist in stability testing
  • Assist in reserve/retention sample and reference sample management.
  • Author, edit, and review SOPs, job aids, reports etc
  • Assist in maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
  • Assist in the investigation into any non-conformance, OOS, OOT, instrument malfunction, accident or other abnormal occurrence per SOPs.
  • Assist in method transfer and method validation
  • Assist in testing, managing, data trending and report writing related to stability
  • Assist in maintenance, calibration, validation and cleaning of QC equipment and instruments
  • Initiate and own deviations, Lab Investigations, CAPAs and change controls within the electronic Quality Management System
  • Assist in diverse qualification activities (facility, cleaning, software etc)
  • Assist in the Microbiology laboratory
  • Keep the QC lab clean, safe and tidy all the times.
  • Work closely and collaboratively with cross-functional team members from QA, QC, production, facility and development.
  • Help with inventory activities, receive and create materials in electronic system.
  • Support the lab with stock and maintain all the materials in stock.
  • Help with ordering activities.
Skills: Qualifications
  • Bachelor’s or Master’s Degree in any Life Sciences with relevant laboratory coursework and 3+ years of relevant experience.
  • Experience with aseptic gowning techniques.
  • Experience in Flow cytometry a must
  • Previous industry experience in a regulated environment highly desired.
  • Ability to handle multiple tasks concurrently, and in a timely fashion.
  • Must have basic understanding of laboratory instrumentation.
  • Must be able to communicate effectively with supervisors and peers.
  • Must be able to read, write and converse in English.
  • Must be computer literate.
  • Able to navigate, conduct searches, and complete online forms on Personal
  • Computer for the purposes of training, performance management, and self service applications.
  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.
  • Knowledge of cGMP manufacturing preferred.
  • Knowledge of basic chemical and biological safety procedures.
  • Must display eagerness to learn and continuously improve.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs.
  • Flow cytometry in BDLyrics (preferred).

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