Neurocrine Biosciences
Scientist, Product Development Early Stage (#YC-1112)
Neurocrine Biosciences, San Diego, California, United States, 92101
About The Role
Work with the Chemistry, Manufacturing, and Controls (CMC) project team to contribute and participate in early discovery through Phase 2a. Provide formulation and analytical support for multiple preclinical programs. Execute pre-formulation and preclinical formation development studies to support product advancement from early discovery through commercial. Support the Product Development team through the following studies: thermodynamic and kinetic solubility, in-use stability, dose verification, toxicology formation development, high performance liquid chromatography (HPLC) method optimization and fit-for-purpose development, and other lead drug development candidates. Prepare and evaluate formulations for administration in preclinical studies. Perform chemical and physical stability studies focused on aqueous, organic, thermal and photo degradation. Present drug development updates during department meetings, prepare author memorandums/reports, and deliver pharmaceutical talks on current and new techniques in support of early product development. Source, procure, install, qualify, operate, and maintain instrumentation and pharmaceutical equipment required for pre-formulation and material science. Participate in weekly and bi-weekly Product Development team meetings and report drug development progress, resource gaps, and timelines. Design and conduct developability assessment of novel peptide therapeutics to enable the selection of a development compound. Support the PD-DDTC (Product Development
Drug Delivery Technology Center) and PD-LS (Product Development
Late Stage) teams in the formulation development and characterization of injectable/parenteral peptides. Design and conduct studies to support scale up during formulation development of peptides/mAbs. Collaborate with the Discovery team for batch characterization to release Gene Therapy test articles for non-GLP (Good Laboratory Practices) and GLP use. Requirements
Bachelor's degree or equivalent in Chemistry, Biochemistry, Chemical Engineering, or a related field. 2 years of experience in the field of pharmaceutical industry in a chemistry, analytical, or characterization laboratory setting. Employer will accept a Master's degree or equivalent in Chemistry, Biochemistry, Chemical Engineering, or a related field in lieu of a Bachelor's degree or equivalent and 2 years of experience in the field of pharmaceutical industry in a chemistry, analytical, or characterization laboratory setting. Work experience to include: (1) Scientific principles, methods, and techniques, including solubility determination, physiochemical characterization of small molecules and biologic modalities, and developability profiling for compound selection (small molecules and biologics). (2) Project management. (3) Current Good Manufacturing Practices (cGMPs) relating to early drug product manufacturing. (4) Physical and analytical techniques. (5) Developing and executing chemical and instrumental methods (including DLS, Viscometer, Osmometer, Endotoxin, HCP ELISA, dPCR, ddPCR, HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, and SEM) of analyses for development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials. 40 hrs./wk. Salary: $88,000 to $140,800/yr. Address of employment: Neurocrine Biosciences, Inc. located at 6027 Edgewood Bend Court, San Diego, CA 92130.
Work with the Chemistry, Manufacturing, and Controls (CMC) project team to contribute and participate in early discovery through Phase 2a. Provide formulation and analytical support for multiple preclinical programs. Execute pre-formulation and preclinical formation development studies to support product advancement from early discovery through commercial. Support the Product Development team through the following studies: thermodynamic and kinetic solubility, in-use stability, dose verification, toxicology formation development, high performance liquid chromatography (HPLC) method optimization and fit-for-purpose development, and other lead drug development candidates. Prepare and evaluate formulations for administration in preclinical studies. Perform chemical and physical stability studies focused on aqueous, organic, thermal and photo degradation. Present drug development updates during department meetings, prepare author memorandums/reports, and deliver pharmaceutical talks on current and new techniques in support of early product development. Source, procure, install, qualify, operate, and maintain instrumentation and pharmaceutical equipment required for pre-formulation and material science. Participate in weekly and bi-weekly Product Development team meetings and report drug development progress, resource gaps, and timelines. Design and conduct developability assessment of novel peptide therapeutics to enable the selection of a development compound. Support the PD-DDTC (Product Development
Drug Delivery Technology Center) and PD-LS (Product Development
Late Stage) teams in the formulation development and characterization of injectable/parenteral peptides. Design and conduct studies to support scale up during formulation development of peptides/mAbs. Collaborate with the Discovery team for batch characterization to release Gene Therapy test articles for non-GLP (Good Laboratory Practices) and GLP use. Requirements
Bachelor's degree or equivalent in Chemistry, Biochemistry, Chemical Engineering, or a related field. 2 years of experience in the field of pharmaceutical industry in a chemistry, analytical, or characterization laboratory setting. Employer will accept a Master's degree or equivalent in Chemistry, Biochemistry, Chemical Engineering, or a related field in lieu of a Bachelor's degree or equivalent and 2 years of experience in the field of pharmaceutical industry in a chemistry, analytical, or characterization laboratory setting. Work experience to include: (1) Scientific principles, methods, and techniques, including solubility determination, physiochemical characterization of small molecules and biologic modalities, and developability profiling for compound selection (small molecules and biologics). (2) Project management. (3) Current Good Manufacturing Practices (cGMPs) relating to early drug product manufacturing. (4) Physical and analytical techniques. (5) Developing and executing chemical and instrumental methods (including DLS, Viscometer, Osmometer, Endotoxin, HCP ELISA, dPCR, ddPCR, HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, and SEM) of analyses for development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials. 40 hrs./wk. Salary: $88,000 to $140,800/yr. Address of employment: Neurocrine Biosciences, Inc. located at 6027 Edgewood Bend Court, San Diego, CA 92130.