Job Description

Compensation & Details:

• 2 Openings
• Fully onsite role in Malvern, PA - in the laboratory
• $34-$38/hr - exact rate is based on several factors, including skills, experience, and education.
• Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law
• 10 PTO Days & 6 Sick Days
• 12 month extending contract

Requirements:

• Minimum two (2) years of relevant work experience
• Experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry
• Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)
• Must have experience in the following: qPCR, cell culture, Flow Cytometry, and/or ELISA
• Ability to read/interpret technical documents such as SOPs, work instructions, test methods and protocols
• Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)

Day to Day: The QC CRS Analyst is responsible for conducting biochemical and testing of drug substance, final product release and characterization samples, and critical reagent qualifications of cell and gene therapy products, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 10 – 15 other Analysts within a functional Clinical Release and Stability (CRS) Laboratory and report to one of two QC CRS Supervisors. Key Responsibilities:

• Conduct analytical biological testing (ELISAs, qPCR, Flow Cytometry, Cell-based assays, etc.) of clinical and commercial drug product/drug substance samples
• Perform peer reviews and approvals of laboratory data
• Use electronic systems (LIMS, MES, Empower, etc.) for execution and documentation of laboratory data
• Support of New Product Initiatives (NPI) in groups of 3-6 analysts
• Perform Instrument Calibration and/or Preventative Maintenance, as needed
• Update CRS-owned documents using the Electronic Document Management System (EDMS)
• Order/receive supplies and manage inventory
• Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities
• Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight
• Complete invalid assay and general laboratory investigation records
• Complete corrective and preventative actions (CAPA) as assigned
• Assist in the execution of internal audits

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