Quality Control- Clinical Release & Stability (CRS) Analyst

Johnson & Johnson Innovative Medicine•Malvern, PA

16d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Malvern, Pennsylvania, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Quality Control- Clinical Release & Stability (CRS) Analyst to be in Malvern, PA, Purpose: 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. This available position will primarily focus on work supporting qPCR.

Requirements

Minimum of a Bachelor’s or equivalent degree in Biology, Biochemistry, Microbiology, Chemistry or related field is required
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)
Experience with the analytical technology of qPCR
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)
Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice outside of Monday-Friday 8:00AM to 4:30PM.
Requires the physical ability to lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting, and ability to perform visual inspections of materials (color, appearance, particles, etc.) and to document observations during laboratory testing
Requires up to 5% of domestic travel

Nice To Haves

CAR-T, Cell and Gene Therapy, or Biochemistry laboratory experience
Experience with analytical technologies used in the CRS Laboratory such as qPCR, cell culture, Flow cytometry, and/or ELISA
Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
Ability to complete equipment and software qualification protocols
Experience developing and setting long-term objectives
Experience working in Biosafety Level (BSL 2, BSL2+) lab or aseptic facility
Experience, training, or certification in Lean, Six Sigma, or Process Excellence tools & methodologies
Knowledge of EU/FDA guidance

Responsibilities

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