Sr Principal Scientist, Process Develop

Location: Malvern

This job is with Johnson & Johnson, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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 Med Tech, 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
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
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Malvern, PA, USA

- Requisition Number: R - 057858
Schaffhausen, Switzerland

- Requisition Number: R - 058708
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Description
We are searching for the best talent for a Senior Principal Scientist, Global Process Development, Drug Product Development & Delivery to be onsite in Malvern, PA or Schaffhausen, CH.

Purpose:

The  Senior Principal Scientist, Global Process Development (GPD), Drug Product Development & Delivery (DPDD) , within Therapeutic Development and Supply (TDS), serves as a  scientific individual contributor and Drug Product process subject-matter expert . The successful candidate will guide and influence the GPD team and the broader DPDD organization on process development, scale-up, and technology transfer for parenteral fill-finish manufacturing; criticality analyses and control strategies;

regulatory strategies; and other topics relevant to various biologics assets (proteins). They will partner with Supply Chain, Quality, Regulatory, and other functions to implement manufacturing processes that meet quality, regulatory, and commercial requirements.
You will be responsible for:
Working independently across GPD, DPDD, TDS, IMSC, and other groups to shape and influence the drug product (DP) process landscape and build a portfolio of value-generating DP process opportunities.
Coaching and mentoring junior scientists on DP process topics.
Establishing and maintaining internal capabilities for biologics DP process development, scale-up, and technology transfer consistent with industry standards and best practices.
Serving as strategist, author, contributor, reviewer, and approver of DP process sections in health authority submissions for biologics.
Partnering with Supply Chain, manufacturing site leads, Quality, Regulatory, and GPD to ensure smooth transfer and introduction of manufacturing processes into production sites in compliance with regulatory requirements.
Designing experiments to identify critical process parameters and proposing detailed control strategies aligned with regulatory expectations and sound business practices.
Interpreting scientific data and conducting critical reviews of global process development study reports.
Leading initiatives for best product/process readiness at launch (right-first-time) and for harmonization and optimization of process development and technology transfer.
Participating in issue-resolution teams by engaging in…