Principal Scientist, Early Development ADSI

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:
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

Johnson & Johnson Innovative Medicine R&D is recruiting for a Principal Scientist, Early Development ASDI located in Malvern, PA.

The Principal Scientist, Early Development Analytical Development Scientific Integrator (ADSI) will be responsible for the following:


* Provide strategic and technical leadership in analytical development and lead a cross-functional scientific team consisting of members from each of the AD sub-functions.


* Represent AD on the CMC team and accountable for all AD project deliverables.


* Lead the execution of critical quality attribute (CQA) assessment, analytical control strategy, and product specifications for programs.


* Lead the analytical review of programs at governance meetings with support from subject matter experts.


* Accountable for submission of complete, consistent, and high-quality regulatory documents to health authorities.
Effectively communicate project status/overview, resources, budget, and issues to senior management.


* Accountable for project risk management including development of appropriate mitigation strategies and escalation to senior management.


* Interact with and influence various stakeholders outside of Discovery, Product Development and Supply (DPDS), including Manufacturing, Regulatory, Quality, Discovery, and external partners.

Qualifications:


* A minimum of a Master's degree in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline is r...