Lenti Investigator

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function:
Supply Chain Manufacturing

Job Sub Function:
Manufacturing Pharmaceutical Process Operations

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

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

We are searching for the best talent for a Lenti Investigator to join our team in Raritan, NJ.

Summary:

The Investigator will lead cross-functional investigations teams to identify true root cause of investigations, conduct risk assessments, and assess the impact of nonconformances.

Key Responsibilities:


* Conduct root cause analysis investigations and author nonconformance reports.


* Coordinate discussion to identify process improvements related to safety, environmental, quality, compliance, efficiency, and yield.


* Recognize and act on potential compliance issues and opportunities for process changes/improvement.


* Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).


* Coordinate data collection and trend analysis in support of nonconformance management and/or audit activities

Qualifications:

Education:


* A minimum of a Bachelor's degree is required, focus degree in Engineering and/or Life Science is preferred.

Experience and Skills:

Required:


* Minimum 2 years of relevant work experience


* Ability to read, analyze, and interpret technical documents,SOPs, common scientific / technical journals, legal documents, and government regulations/guidance documents (EU GMPs, Annex 1, CFR, USP)


* Excellent written and oral communication skills


* Experience within cell/gene therapy, biopharmaceutical, or pharmaceutical industry

Preferred:


* Experience wi...