Senior Principal Scientist, Bioanalytical Outsourcing

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 .

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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:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmacokinetics & Pharmacometrics

Job Category:
Scientific/Technology

All Job Posting Locations:
Spring House, Pennsylvania, 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 Senior Principal Scientist, Bioanalytical Outsourcing, located in Spring House, PA.

Purpose: This is a scientific position within the Bioanalytical Discovery and Development Sciences (BDDS) group within the Preclinical Sciences and Translational Safety (PSTS) organization.

This group is responsible for developing, validating, and conducting bioanalytical methods to support preclinical and clinical development of synthetic and biologic-based drugs.

The primary focus for this position is to place and manage a set of assays at external organizations supporting GLP and clinical-stage programs, there may be some responsibility for discovery stage programs.

You will be responsible for:


* Comprehensive oversight of all bioanalytical assays-including drug quantitation, immunogenicity (ADA and Nab), and soluble target engagement-across assigned programs and analytical platforms at external partners, ensuring seamless execution of bioanalytical activities from initiation through reporting.


* Coordinate review process of the supply agreements, protocols, reports, regulatory filings as appropriate.



* Ensure that all contractual obligations with external partners are met, including closely monitoring deliverables, timelines, cost, and quality standards as outlined in contracts.

Submit and track status of work orders and change orders through internal business systems.


* Lead regular meetings with CRO labs to...