Patricia Johnson
30+ yrs pharmaceutical experience Strong Regulatory CMC knowledge Strong analytical chemistry background Experience overseeing contract manufacturing API and drug product Big pharma... | Princeton, New Jersey, United States
Patricia Johnson's Emails pj****@oy****.com
No phone number available.
Patricia Johnson's Location Princeton, New Jersey, United States
Patricia Johnson's Expertise 30+ yrs pharmaceutical experience Strong Regulatory CMC knowledge Strong analytical chemistry background Experience overseeing contract manufacturing API and drug product Big pharma and small biotech experience (including two IPOs) Wrote and compiled multiple INDs and NDA CMC sections for global regulatory applications Excellent working relationship with FDA Ophthalmology Experience: Prepared the CMC sections of INDs and NDAs as well as Clinical Trial Applications ex-US for ophthalmic products. Responsible for analytical method transfers, review of protocols, approval of methods for all non-clinical , clinical, API and finished drug product testing. Ensured conformance to ophthalmic specific criteria. Worked with manufacturing sites on process development and review of Batch Records for the manufacture of APIs and Finished Drug Products. Specialties: Analytical Chemistry, Manufacturing, Regulatory CMC, Regulatory Affairs,
Patricia Johnson's Current Industry Oyster Point Pharma
Patricia Johnson's Prior Industry Merck | Pharmasset | Regulatory Cmc Illumination | Ophthotech | Oyster Point Pharma
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FAQ About Patricia Johnson
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Patricia Johnson is located at
Princeton, New Jersey, United States -
Patricia Johnson is a
30+ yrs pharmaceutical experience Strong Regulatory CMC knowledge Strong analytical chemistry background Experience overseeing contract manufacturing API and drug product Big pharma and small biotech experience (including two IPOs) Wrote and compiled multiple INDs and NDA CMC sections for global regulatory applications Excellent working relationship with FDA Ophthalmology Experience: Prepared the CMC sections of INDs and NDAs as well as Clinical Trial Applications ex-US for ophthalmic products. Responsible for analytical method transfers, review of protocols, approval of methods for all non-clinical , clinical, API and finished drug product testing. Ensured conformance to ophthalmic specific criteria. Worked with manufacturing sites on process development and review of Batch Records for the manufacture of APIs and Finished Drug Products. Specialties: Analytical Chemistry, Manufacturing, Regulatory CMC, Regulatory Affairs, Oyster Point Pharma -
Patricia Johnson currently works in the
Oyster Point Pharma -
Patricia Johnson specializes in
30+ yrs pharmaceutical experience Strong Regulatory CMC knowledge Strong analytical chemistry background Experience overseeing contract manufacturing API and drug product Big pharma and small biotech experience (including two IPOs) Wrote and compiled multiple INDs and NDA CMC sections for global regulatory applications Excellent working relationship with FDA Ophthalmology Experience: Prepared the CMC sections of INDs and NDAs as well as Clinical Trial Applications ex-US for ophthalmic products. Responsible for analytical method transfers, review of protocols, approval of methods for all non-clinical , clinical, API and finished drug product testing. Ensured conformance to ophthalmic specific criteria. Worked with manufacturing sites on process development and review of Batch Records for the manufacture of APIs and Finished Drug Products. Specialties: Analytical Chemistry, Manufacturing, Regulatory CMC, Regulatory Affairs, -
Patricia Johnson speaks the following languages:
No languages available. -
Patricia Johnson has prior experience in the following industries:
Oyster Point Pharma , Ophthotech , Pharmasset , Merck , Merck -
Patricia Johnson has the following professional experience:
Oyster Point Pharma , Ophthotech , Regulatory Cmc Illumination , Pharmasset , Merck , Merck . -
You can view Patricia Johnson’s
LinkedIn profile at LinkedIn URL. -
Patricia Johnson’s work email addresses are
[email protected] . -
Patricia Johnson works at
Oyster Point Pharma
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