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CAR-T Manufacturing Batch Advocate, Senior Analyst - 2406180788W

Description

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Batch Advocate, Senior Analyst!

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/.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity!

The CAR-T Manufacturing Batch Advocate, Senior Analyst is responsible for directly providing hope for our CAR-T patients. As a team, we work directly with relevant patient batch partners at the manufacturing facility applying helpful specialized technical influence at any step within the manufacture or release process. The Lead serves as the ‘Voice of the Batch.’ The Batch Advocate team, Medical Affairs, and a specialized CAR-T site-facing team will speak with commercial sites providing technical insight to facilitate informed patient treatment decisions. The team directly influences and improves release time of all batches.

Key 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

• Responsibilities span receipt to release from the CAR-T manufacturing facility

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

• Collaborate with manufacturing team members to monitor and add influence to expedite resolution of any realized batch delays

• Maintain a digital case report for each patient batch requiring delay or release monitoring

• Support onboarding and training of new country commercial launches for outstanding release process flows

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

Qualifications

Education:

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

Experience and Skills:

Required:

• Minimum 4 years of relevant work experience

• GxP Technical Operations, Quality, or Manufacturing experience

• Shown work experience in a CAR-T GMP manufacturing setting

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

• Experience in writing, implementing, and reviewing Operations manufacturing SOPs, Work Instructions, and Batch Records

• Strong interpersonal skills, positive mentality, and capability of working in a collaborative team environment to effectively 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

Other:

• Fluency in English required to proficiently read/write/speak to conduct technical discussions; 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

The anticipated base pay range for this position is $ 90,000- $ 144,900 USD.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year

• Holiday pay, including Floating Holidays – up to 13 days per calendar year

• Work, Personal, and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits_ _.

This job posting is anticipated to close on April 23, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com_ _to accept additional applications.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-New Jersey-Raritan

Organization Janssen Pharmaceuticals, Inc. (6062)

Travel Yes, 10 % of the Time

Job Function Strategic Sourcing

Req ID: 2406180788W