Senior Scientist, Biologics Analytical Development

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:
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 Senior Scientist, Biologics Analytical Development role to be in Malvern, PA.

You will be responsible for:


* developing, validating, and transferring biochemical methods in accordance with ICH Q2(R2) and Q14, focusing on capillary electrophoresis (CE) and HPLC methods for biopharmaceutical product characterization and quality control.


* serving as the analytical technical expert during method development, regulatory filings, and inspections.


* fostering strong collaborations while maintaining a focus on customer needs.


* innovating and implementing cutting-edge approaches for analytical method development.


* providing deep analytical expertise for programs from early-phase to late-phase clinical development and commercial manufacturing.


* analyzing and communicating complex data succinctly and clearly.


* leading continuous improvement initiatives for methods, processes, and scientific procedures.


* writing, reviewing and approving validation/transfer protocols, technical reports, SOPs and present data to peers and functional management.


* authoring/reviewing relevant sections of regulatory filings including INDs, IMPDs and BLAs, addressng inquiries from the health authorities


* contributing to laboratory operations improvements, enhancing efficiency and GMP compliance.


* serving as an Instrument owner and manage instrument maintenance and qualification

Qualifications / Requirements:

Education:


* a minimum of a Bachelor’s degree is required


* a PhD or Master’s degree is highly preferred

Required:


* a minimum of 2 years experience in the pharmaceutical/biotech industry or post-doctoral experience is required


* Proven scientific ex...