Analyst QC CRS

<p style="text-align:left !important">At Johnson &amp; 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 <a target="_blank" href="https://www.jnj.com"><span style="color:#0000ff"><u>jnj.com</u></span></a></p><p></p><p>As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span><span>Job Function: </span></span></b></p>Quality<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Quality Control<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Category:</b></p>Professional<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>All Job Posting Locations:</b></p>Malvern, Pennsylvania, United States of America<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Description:</b></p><p>About Innovative Medicine</p><p>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.</p><p>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</p><p>The QC CRS Experienced 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. This role is responsible for performing and overseeing analytical release, maintaining GMP-compliant documentation, supporting method qualification/validation, and partnering with manufacturing, QA, and regulatory teams to ensure the safety, identity, purity, potency, and stability of clinical cell therapy materials. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. The position requires analytical testing to be completed in compliance with all applicable procedures, standards and GMP regulations. This position requires high attention to detail, organizational leadership, interpersonal skills, a quality mindset, and critical thinking, and technical writing skills.</p><p></p><p><b>Key Responsibilities:</b></p><ul><li>Perform analytical testing in compliance with applicable GMP regulations while maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations.</li><li>Maintain individual training completion in a compliant state</li><li>Conduct analytical biological testing (ELISAs, qPCR, Flow Cytometry, Cell-based assays, etc.) of clinical drug substance, drug product, characterization, and/or critical reagent samples</li><li>Review and approve QC data, test records; escalate out-of-specification (OOS) results and support investigations.</li><li>Execute and document sample receipt, chain-of-custody, sample preparation, testing, and data review in accordance with SOPs and GMP.</li><li>Experience with viral vector handling and manufacturing (lentiviral/retroviral) and understanding of biosafety requirements.</li><li>On-site laboratory work in a controlled environment with BSL-2/2&#43; practices</li><li>Use electronic systems (eLIMS, MES, Empower, etc.) for execution and documentation of testing</li><li>Support of New Product Introductions (NPI)</li><li>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</li><li>Perform Instrument Calibration and/or Preventative Maintenance, as needed</li><li>Order/receive supplies and manage inventory</li><li>Update CRS-owned documents using the Electronic Document Management System (EDMS)</li><li>Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight</li><li>Complete invalid assay and support laboratory investigation records</li><li>Complete corrective and preventative actions (ACTs), as assigned</li><li>Assist in the execution of internal audits or inspections</li><li>Maintain Laboratory in audit ready state and participate in internal and Health Authority inspections</li><li>Provide input to functional laboratory meetings</li></ul><p></p><p><b>Qualifications:</b></p><p>Education:</p><p>Minimum of a Bachelor’s or equivalent degree in Biology, Biochemistry, Microbiology, Chemistry or related field is required</p><p></p><p>Required:</p><ul><li>Minimum 4–6 years of hands-on experience in cell therapy or biologics laboratories; direct CAR-T or T-cell processing experience strongly preferred.</li><li>Demonstrated experience with flow cytometry, qPCR/ddPCR, and cell-based assays used for release and characterization.</li><li>Working knowledge of microbiological assays relevant to GMP (sterility, mycoplasma, endotoxin) and environmental monitoring practices.</li><li>Strong understanding of GMP/GLP principles and experience working in or supporting GMP manufacturing laboratories.</li><li>Experience with QC documentation practices: SOPs, batch records, test reports, deviation/CAPA processes, and audit readiness.</li><li>Familiarity with LIMS, ELN, or comparable laboratory data management systems; solid computer skills and basic data analysis capability.</li><li>Excellent attention to detail, organizational skills, and ability to prioritize under time pressure.</li><li>Strong written and verbal communication skills; ability to interact effectively with cross functional teams and regulators.</li><li>Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)</li><li>Excellent troubleshooting, organizational, and record-keeping skills</li></ul><p>Preferred:</p><ul><li>CAR-T, Cell and Gene Therapy, or Biochemistry laboratory experience</li><li>Experience with analytical technologies used in the CRS Laboratory such as qPCR, cell culture and maintenance, Flow cytometry, and/or ELISA</li><li>Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC</li><li>Experience developing and setting long-term objectives</li><li>Knowledge of EU/FDA guidance</li><li>Detailed knowledge and experience in applying statistical concepts to laboratory data</li><li>Familiarity with stability study design and accelerated/real time stability testing for cell therapy products.</li><li>Experience in implementing continuous improvement or lean practices in a QC setting.</li></ul><p></p><p>Other:</p><ul><li>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.</li><li>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</li></ul><p></p><p>Requires up to 5% of domestic travel</p><p></p><p><span>Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.</span></p><p></p><p><span>Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.</span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p><b>Required Skills:</b></p><p> </p><p> </p><p><b>Preferred Skills:</b></p>Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy<p> </p><p> </p><p><b><span>The anticipated base pay range for this position is :</span></b></p>$79,000.00 - $127,650.00<p></p><p></p><p><u>Additional Description for Pay Transparency:</u></p>ubject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).<br><br><br><br><br>This position is eligible to participate in the Company’s long-term incentive program.<br><br><br><br>Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:<br><br>Vacation –120 hours per calendar year<br><br>Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year<br><br>Holiday pay, including Floating Holidays –13 days per calendar year<br><br>Work, Personal and Family Time - up to 40 hours per calendar year<br><br>Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child<br><br>Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year<br><br>Caregiver Leave – 80 hours in a 52-week rolling period10 days<br><br>Volunteer Leave – 32 hours per calendar year<br><br>Military Spouse Time-Off – 80 hours per calendar year<br><br>For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits