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 expertise with extensive hands-on experience in protein isolation and separation techniques, including electrophoresis and chromatography is required
• First-author publication is required
• Exceptional planning and tracking abilities with a results-oriented mindset, adept at managing multiple projects while respecting priorities and resources is required
• Excellent organizational, communication, and presentation skills, combined with strong scientific and technical writing abilities are required
• Demonstrated ability to collaborate effectively in a fast-paced team environment and quickly acquire new technical skills is required

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.