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Company

Original Job Post

Johnson & Johnson · 3 days ago

CAR-T Manufacturing Batch Advocate Senior Analyst

Raritan, NJ

Full-time

Onsite

Senior Level

$90K/yr - $145K/yr

5+ years exp

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Health CareMedical Device

H1B Sponsorship

Comp. & Benefits

Insider Connection @Johnson & Johnson

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Collaborate with CAR-T manufacturing and Quality teams to identify early indications a batch may be delayed for any reason

Immediately assess and prioritize any issue for further alert, action or monitoring

Upon confirmation of a batch delay, populate a specialized batch monitoring platform

Provide a specialized level of care to every delayed batch of CAR-T material

Support onboarding and training of new country commercial launches for development of exceptional release process flows

Support development and future monitoring of new manufacturing facility workflows for batches that require delay

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Technical OperationsQuality ControlManufacturingCAR-T GMPAutomated Cell CountersQPCR MethodsMulti-color Flow CytometryELISA MethodsCell CultureBAC-T SterilitySOPsWork InstructionsBatch RecordsInterpersonal SkillsPositive MentalityCollaborative TeamworkComprehending CAR-T batch dataQuality InvestigationsQuality Management SystemsGermanJapaneseFrenchPortugueseDutchAvailability within 12 hours

Required

Minimum of a bachelor's or equivalent University Degree required; focused degree in Immunology, Molecular Biology, Bio-Pharmaceutical Manufacturing, or equivalent field preferred

Minimum 5 years of relevant work experience

Experience in Technical Operations, Quality Control or Manufacturing

Work experience in a CAR-T GMP manufacturing setting

Extensive knowledge and/or hands-on experience performing tests using and interpreting data from one or more of the following: Automated cell counters, qPCR Methods, Multi-color flow cytometry, ELISA methods for cytokines, Cell Culture, and/or BAC-T sterility

Experience in writing, implementing, or reviewing Operations manufacturing SOPs, Work Instructions, Batch Records, or Investigations

Strong interpersonal skills, positive mentality, and capability of working in a collaborative team environment to optimally relate to all aspects of the manufacturing teams

Preferred

Proficiency in comprehending CAR-T batch data and clearly communicating it to doctors for informed patient care decisions

Experience in Quality Investigations within a Manufacturing Operations or Quality Control setting

Experience in Quality Management Systems within a Manufacturing setting

Fluency in German, Japanese, French, Portuguese, and/or Dutch is preferred

Requires availability within 12 hours to connect with sites as needed, locally and globally

Requires up to 10% of domestic and/or international travel

Benefits

Medical

Dental

Vision

Life insurance

Short- and long-term disability

Business accident insurance

Group legal insurance

Pension

401(k)

Vacation

Sick time

Holiday pay

Work, Personal, and Family Time

Company

Johnson & Johnson

Glassdoor

4.2

Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.

Founded in 1886

New Brunswick, New Jersey, USA

10,001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (43)

2022 (55)

2021 (40)

2020 (30)