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 Title: Experienced Scientist I
Job Location: Malvern, PA
Job Type: Full-Time
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.
This job posting is anticipated to close on 6/10/2026.
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:
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• 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
Required Skills:
Preferred Skills:
