Analyst QC CRS

Johnson & Johnson Innovative Medicine•Malvern, PA

5d•$79,000 - $127,650•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 jnj.com As guided by Our Credo, Johnson & 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 & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 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.

Requirements

Minimum of a Bachelor’s or equivalent degree in Biology, Biochemistry, Microbiology, Chemistry or related field is required
Minimum 4–6 years of hands-on experience in cell therapy or biologics laboratories; direct CAR-T or T-cell processing experience strongly preferred.
Demonstrated experience with flow cytometry, qPCR/ddPCR, and cell-based assays used for release and characterization.
Working knowledge of microbiological assays relevant to GMP (sterility, mycoplasma, endotoxin) and environmental monitoring practices.
Strong understanding of GMP/GLP principles and experience working in or supporting GMP manufacturing laboratories.
Experience with QC documentation practices: SOPs, batch records, test reports, deviation/CAPA processes, and audit readiness.
Familiarity with LIMS, ELN, or comparable laboratory data management systems; solid computer skills and basic data analysis capability.
Excellent attention to detail, organizational skills, and ability to prioritize under time pressure.
Strong written and verbal communication skills; ability to interact effectively with cross functional teams and regulators.
Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)
Excellent troubleshooting, organizational, and record-keeping skills
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 and maintenance, Flow cytometry, and/or ELISA
Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
Experience developing and setting long-term objectives
Knowledge of EU/FDA guidance
Detailed knowledge and experience in applying statistical concepts to laboratory data
Familiarity with stability study design and accelerated/real time stability testing for cell therapy products.
Experience in implementing continuous improvement or lean practices in a QC setting.

Responsibilities

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.
Maintain individual training completion in a compliant state
Conduct analytical biological testing (ELISAs, qPCR, Flow Cytometry, Cell-based assays, etc.) of clinical drug substance, drug product, characterization, and/or critical reagent samples
Review and approve QC data, test records; escalate out-of-specification (OOS) results and support investigations.
Execute and document sample receipt, chain-of-custody, sample preparation, testing, and data review in accordance with SOPs and GMP.
Experience with viral vector handling and manufacturing (lentiviral/retroviral) and understanding of biosafety requirements.
On-site laboratory work in a controlled environment with BSL-2/2+ practices
Use electronic systems (eLIMS, MES, Empower, etc.) for execution and documentation of testing
Support of New Product Introductions (NPI)
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
Maintain Laboratory in audit ready state and participate in internal and Health Authority inspections
Provide input to functional laboratory meetings

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
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
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year