Joseph Kutza
Senior Director, Regulatory CMC Policy at Eli Lilly
- Role
- Senior Director, Regulatory Cmc Policy at Eli Lilly at Eli Lilly and Company
- Location
- Germantown, MD, US
- LinkedIn followers
- 500 followers
About Joseph Kutza
CMC Regulatory Affairs Professional within a well-established Pharmaceutical Company; Experience with US and International post-approval CMC submissions, MAA\'s, advocacy and intelligence for biologic products- FDA Product Reviewer for monoclonal antibodies including clinical products, licensed products and inspection experience (US, International, Drug Substance and Drug Product)- HIV Research with emphasis on the role of macrophages and cytokines in the infection process- Goal: To understand the biotechnology product development and review lifecycle from the perspective of both the regulators and the regulated.Specialties: Monoclonal antibodies; CMC Regulatory Affairs; US and ICH Guidance documents for Biotechnology Products, US Regulations for Biotechnology Products
Experience
Senior Director, Regulatory Cmc Policy at Eli Lilly
Apr 2023 — Present · MD, US
Education
Misericordia University
B.S., Biology/Chemistry
1984 — 1988
Drexel University College of Medicine
Ph.D., Immunology
1989 — 1995
Medical College of Pennsylvania
Ph.D., Immunology
1989 — 1995
Skills
- Regulatory Affairs
- Lifesciences
- Clinical Research
- Protein Chemistry
- Cmc
- Gmp
- Ind
- Drug Development
- Biopharmaceuticals
- Monoclonal Antibodies
- Immunology
- Product Development
- Technology Transfer
- Fda Gmp
- Biotechnology
- Pharmaceutical Industry
- Fda
- Strategy
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