Principal Scientist, External Analytical

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 https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Biotherapeutics R&D

Job Category:
Scientific/Technology

All Job Posting Locations:
Malvern, 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 Principal Scientist to be in Malvern, PA

Purpose:

Material Sciences is a technical, scientific department within the Therapeutics Development and Supply (TDS) organization.

We are expanding our team to strengthen our technical capability around raw materials used in our Biotherapeutics portfolio.

The Analytical Scientist will act as an analytical Subject Matter Expert (SME) and have various responsibilities centered around external analytical development activities.

You will be responsible for:


* Identifying, developing, qualifying, validating, implementing analytical methods for raw materials and related in-process samples (e.g., bioreactor samples and formulations).

Support Chemistry, Manufacturing and Controls (CMC) development studies, material qualification, Quality Control (QC) release testing, and investigations.


* Overseeing external method development activities at global network of contract labs (CROs).


* Designing and carrying out experiments in support of analytical characterization of raw materials.

Building analytical capability, including evaluation of new instruments and methods.

Supporting enhanced characterization and data analysis, including statistical modeling.


* Collaborating within TDS Material Sciences, Active Pharmaceutical Ingredient (API) Protein Upstream and Downstream teams on testing plans.

Establish raw materials controls in-process and formulation design.


* Leading method development projects and participate in scientific meetings to share knowledge and foster a culture of scientific thinking.

Ensure the accurate and timely preparation of technical reports.

Providing guidance toward development of specifications for various materials including cell culture media, resin...