33 applicants
Johnson & Johnson · 3 days ago
Senior Associate Scientist, Cell & Gene Therapy, Materials Sciences
Malvern, PA
Full-time
Onsite
Mid Level
2+ years exp
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Responsibilities
Perform lab studies in support of raw materials for cell and gene therapy (CGT) for the purposes of characterization, qualification, and investigations. NOTE: This role will require >50% lab-based work.
Collaborate with Contract Manufacturing Organizations (CMOs) to define appropriate controls for the qualification of raw materials, and support supplier and material qualification.
Partner with API Protein, API CGT, and Drug Product development teams to define relevant material selection, assessments, and control strategies.
Collaborate with Chemistry, Manufacturing, and Controls (CMC) teams to support internal manufacturing sites and external sites (CMOs).
Interpret and implement industry and regulatory guidance for raw materials, ensuring compliance with Good Manufacturing Practices (GMP), quality, and scientific principles.
Author, review, and approve raw material sections of regulatory documents for global filing of J&J Innovative Medicines biotherapeutics drugs as required.
Support raw material-related requests for internal and regulatory authority audits.
Qualification
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Required
Minimum of a Bachelor's degree in Chemistry, Biology, Materials Science and Engineering, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics, or related field with a minimum of 2-4 years of experience OR a Master's degree with at least 1 year of experience is required.
Demonstrated experience working effectively in a matrixed team environment is required.
Demonstrated lab experience using analytical instrumentation is required.
Proficiency in Microsoft Office tools (Excel, Word, PowerPoint).
Preferred
Analytical testing experience working with materials used for the production of cell and gene therapies.
Experience in API development activities for biotherapeutics.
Proficiency in knowledge of raw materials including cell culture media, chemicals, and excipients used in biotherapeutic products.
Proficiency and experience in quality investigations, change control, troubleshooting, and regulatory submissions.
Proficiency and experience in product/process (CMC) development, technology transfer, or investigations within the biopharmaceutical industry.
Company
Johnson & Johnson
Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.
10,001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (43)
2022 (55)
2021 (40)
2020 (30)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO· nyse:JNJ
Leadership Team
Alex Gorsky
Chairman & CEO
Dominic J. Caruso
Vice President, Finance and Chief Financial Officer
Recent News
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2024-05-24
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