Principal Scientist, Bioanalytical Outsourcing

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

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmacokinetics & Pharmacometrics

Job Category:
Scientific/Technology

All Job Posting Locations:
Beerse, Antwerp, Belgium

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 Principal Scientist, Bioanalytical Outsourcing to be 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 small molecule 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.

You will be responsible for:


* Complete oversight of the bioanalytical assays (pharmacokinetics, immunogenicity and soluble target engagement)


* Oversight of all bioanalytical-related activities across assays and platforms for assigned programs at external partners.

Ensure smooth conduct from initiation to reporting.


* Review all proposed with key partners work prior to initiation


* Coordinate review process of the protocols/supply agreements/regulatory filings as appropriate


* Confirm all partners are satisfied with protocols/supply agreements/regulatory filing process.


* Implement contracts between J&J and external partners


* Ensure all appropriate legal approvals are obtained for planned studies


* Work with business operations, procurement and legal to settle study costs and ensure these are communicated and agreement with key partners


* Apply internal systems to submit work orders and change orders


* Record and track status of purchase orders and changes orders in planning system


* Update status of projects as landmarks are reached


* Lead regular meetings with CRO lab(s) t...