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.
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: Employer: Janssen Research & Development, LLC
Job Duties: Perform lab studies to support raw materials for CGT, focusing on characterization, qualification, and investigations (>50% lab-based work). Collaborate with CMOs to define appropriate controls for raw material qualification and support supplier and material qualification processes. Partner with API Protein, API CGT, and Drug Product development teams to define relevant material selection, assessments, and control strategies. Collaborate with CMC teams to support both internal manufacturing sites and external CMOs. Interpret and implement industry and regulatory guidance for raw materials, ensuring compliance with GMP, quality standards, and scientific principles. Author, review, and approve raw material sections of regulatory documents for global filings of J&J IM biotherapeutic drugs, as required. Support raw material-related requests during internal and regulatory authority audits.
Requirements: Employer will accept a Bachelor degree in Medicinal Chemistry, Materials Science, Biomedical Engineering, Chemical Engineering, Pharmacy, or related field and 2 years of experience in the job offered or in an Experienced Scientist I-related occupation.
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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
For additional general information on Company benefits, please go to: – https://www.careers.jnj.com/employee-benefits
Tagged as: Life Sciences
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