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 Scientist, Process Analytical Sciences - Bioassay, Cell & Gene Therapy to be located in Malvern, PA.

Purpose: Within Johnson and Johnson, the Therapeutics Development & Supply (TDS) organization is responsible for the development, clinical supply, marketed product support, and life cycle management of Biotherapeutics. Within TDS, the Analytical Development (AD) group supports method development and validation, release, and stability analysis. The Process Analytical Sciences – Bioassay, Cell and Gene Therapy group within AD is seeking a Scientist to provide analytical bioassay testing for early and late-stage development samples supporting the biologics (Mabs, Bi-specific’s, Tri-specific’s), cell and gene therapy portfolios.

The successful candidate will be responsible for non-GMP and GMP analytical testing and data review as well as participating in method qualifications and validations.

You will be responsible for:

• Conducting Bioassay testing to support the biologics, cell and gene therapy portfolios and perform data review according to GXP standards, SOPs, and protocols.
• Planning, conducting, and advising on analytical characterization of development projects; support method development, qualification, validation, and transfer activities.
• Demonstrating excellent oral and written communication and interpersonal skills; act as liaison and point of contact for local teams and global operations; serve as representative on cross-functional teams.
• Engaging in a dynamic team environment and provide mentorship and training to scientific staff.
• Exhibiting strong technical, writing, and organizational skills combined with great attention to detail to ensure adherence to department and industry regulatory standards.
• Addressing complex problems through data analysis requiring strong process knowledge and in-depth evaluation of multiple variables; use project metrics and lessons learned to improve business results and product launch processes in the region.

Qualifications / Requirements:

Education:

• A minimum of a Bachelor's degree is required, preferably in Chemistry, Biochemistry or a related field. An advanced degree (Master's) is preferred.

Experience and Skills:

• 2+ years of Pharma/Biotech industry experience is required.
• Experience with combination of some of the following techniques, including ELISA, qPCR, Flow Cytometry, cell-based potency assays, or plate-based biochemical assays is required.
• Experience working in a cGMP environment is preferred.
• Experience with electronic laboratory notebook, programming, database structures, data trending, and forecasting is preferred.
• Excellence in bioassay troubleshooting and routine instrument maintenance is preferred.
• Excellent interpersonal skills (written and oral) and the ability to work in a cross-functional customer-focused environment is preferred.
• Ability to work with limited guidance to plan, complete, and follow through with studies is preferred.

Other:

• This role is based in Malvern and may require up to 5% of domestic and international travel.

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.

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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.