Analyst Quality Control, Analytics

Biopharma Asia; Raritan (NJ); On-site; USD 66,000 - 107,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Raritan, NJ is seeking an Analyst, Quality Control Analytics - CAR-T to support biochemical, microbiological, and general testing of final product samples within a GMP environment.

The role requires 2+ years of relevant experience with qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays, plus knowledge of cGMP/GDP. Occasional weekend support and collaboration with an 5–15 person team are expected.

Qualifications

• Minimum of two (2) years of relevant work experience.
• Techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays.
• Experience in Biopharmaceutical or Pharmaceutical industry.
• Aseptic processing in biosafety cabinets and/or ISO 5 clean room.
• GDP and cGMP knowledge.
• Quality Control document reviews and regulatory inspection processes.
• Proficient in technical writing of test methods and SOPs.
• Excellent written and verbal communication skills.

Responsibilities

• Perform analytical testing and maintain a safe work environment in compliance with all applicable procedures, EHS, and GMP regulations
• Perform peer review/approval of laboratory data and logbooks
• Use electronic systems (e.g., LIMS, iLAB) for execution and documentation of testing
• Build, review, and approve relevant QC documents, SOPs, and WIs
• Complete invalid assay and general laboratory investigation records, CAPAs, change controls
• Support Health Authority inspections
• Provide input to functional laboratory meetings

Skills

qPCR

Flow Cytometry

ELISA

Cell Culture

Potency assays

cGMP

GDP

Technical writing

Communication

Education

Bachelor's degree

MSc/PhD preferred

Tools

LIMS

iLAB

SAP

Job description

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - CAR-T in Raritan, NJ! This shift is going to be scheduled 8:00am - 6:00pm through Sunday - Wednesday.

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/.

The QC Analyst is responsible for conducting biochemical, microbiological, and/or general testing of final product samples submitted to the QC laboratories. 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 5 – 15 other Analysts within the functional laboratory of the Quality Control department.

Key Responsibilities:

• Perform analytical testing and maintain a safe work environment in compliance with all applicable procedures, EHS, and GMP regulations
• Perform peer review/approval of laboratory data and logbooks
• Use electronic systems (e.g., LIMS, iLAB) for execution and documentation of testing
• Build, review, and approve relevant QC documents, SOPs, and WIs
• Complete invalid assay and general laboratory investigation records, CAPAs, change controls
• Support Health Authority inspections
• Provide input to functional laboratory meetings

Qualifications:

Education:

Minimum of a Bachelor’s or equivalent University Degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, Chemistry, or related scientific field is preferred

Experience and Skills:

Required:

• Minimum of two (2) years of relevant work experience
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Experience within Biopharmaceutical or Pharmaceutical industry
• Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room
• Demonstrated experience successfully working in an analyst role/level and proficiency using analytical methodologies within a functional laboratory
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Experience with Quality Control document reviews and regulatory inspection processes
• Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
• Excellent written and verbal communication skills

Preferred:

• Work experience in Cell and/or Gene Therapy or Biologics
• Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
• Experience with LIMs and SAP or equivalent systems
• Experience, training, or certification with Process Excellence tools and methodologies

Other:

• Requires ability and flexibility to work 10-hour shifts between the operational hours of 8:00am - 6:00pm (Sunday - Wednesday), and provide occasional support on the weekends or other shifts
• Requires the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing
• Requires up to 5% domestic travel to other sites/locations

Johnson & 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.

Johnson & J & 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.

#car-t

The anticipated base pay range for this position is :

$66,000.00 - $106,950.00

Additional Description for Pay Transparency:

Subject 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)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits