QC Analyst II, Cell Therapies Laboratory (t375)

  • Contract Duration: 6++ months, Onsite
  • Research & Development
  • Cambridge, MA

Website Lenox Executive Search

Lenox Executive Search is seeking an experienced Quality Control Analyst, to fill a 6++ month Cell Therapies related onsite contractual role, with a leading global pharmaceutical company in Cambridge, MA.

*This role requires full vaccination against COVID-19 as a condition of assignment, subject to a valid and approved medical or religious accommodation.

OBJECTIVES:

•       The Analyst, Cell Therapies QC Laboratory is 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.
•       This position supports internal QC testing as well as assistance with management of contract testing laboratories.
•       This position is responsible to 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.

RESPONSIBILITIES:

•       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 work 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 and as needed.
•       Assist in stability testing as needed.
•       Assist in reserve/retention sample and reference sample management.
•       Author, edit, and review SOPs, job aids, reports etc. as assigned.
•       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 as needed.
•       Assist in testing, managing, data trending and report writing related to stability as needed.
•       Assist in maintenance, calibration, validation and cleaning of QC equipment and instruments as needed.
•       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) as needed.
•       Assist in the Microbiology laboratory as needed.
•       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.
•       Experience with aseptic gowning techniques.
•       Additional duties as assigned.

REQUIREMENTS:
• Bachelor’s or Master’s Degree in any Life Sciences with relevant laboratory coursework and 3+ years of relevant experience.
• 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.
• In general, the position requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs.

PHYSICAL DEMANDS:
•       In general, the position requires a standing for extended periods of time in the Quality Control laboratory.
•       This role supports pharmaceutical production operations therefore the work environment includes exposure to production and cell processing facilities, packaging, component printing and analytical laboratories (this list is not exhaustive).

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