Experienced Scientist I

Experienced Scientist I Malvern, PA 4 DAYS AGO 22537358 Summary Malvern, PA In-Person Competitive Salary 2 Years Experience Bachelor's degree No Commission 40.00 hours per week / Day Shift / Full-Time

Description Employer:

Janssen Research & Development, LLC Job Title:

Experienced Scientist I Job Code:

A011.9674.6

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.

Apply online at https:

//www.careers.jnj.com/en/jobs/r-072679/experienced-scientist-i/ Additional Details How To Identify Potential Job Scams

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