Joseph P. B.

Joseph P. B. Email and Phone Number

Product Development Scientist @ Lifecycle Biotechnologies, LP
fort worth, texas, united states
Joseph P. B.'s Location
Cleburne, Texas, United States, United States
Joseph P. B.'s Contact Details

Joseph P. B. personal email

About Joseph P. B.

Experienced formulation scientist and project lead with proven track record spanning more than twenty five years in the pharmaceutical industry. Extensive experience in pharmaceutical research and development, ranging from physicochemical characterization of early drug candidates, preformulation and formulation research and development of early and late stage ophthalmic, otic and nasal drug products and ocular surgical medical devices, through technical transfers for clinical and commercial manufacture, regulatory submissions and post-approval product support. Broad technical knowledge and skills and strong program and project management skills.

Joseph P. B.'s Current Company Details
Lifecycle Biotechnologies, LP

Lifecycle Biotechnologies, Lp

View
Product Development Scientist
fort worth, texas, united states
Website:
lifecyclebio.com
Employees:
12
Joseph P. B. Work Experience Details
  • Lifecycle Biotechnologies, Lp
    Product Development Scientist
    Lifecycle Biotechnologies, Lp Dec 2022 - Present
    Cleburne, Texas, United States
  • Freelance
    Pharmaceutical Consultant
    Freelance Jun 2021 - Dec 2022
  • Novartis
    Formulation Project Lead
    Novartis Nov 2016 - Jun 2021
    Fort Worth, Texas
    Formulation and Process Development,Parenteral, Topical and Ophthalmic Pharmaceutical Development Unit,Technical Research and Development,Global Drug DevelopmentPlan, coordinate and supervise Formulation and Process Development activities with Drug Product Project Leads and Formulation Scientists in FPD, Analytical Project Leads and Analytical Scientists in Analytical Research and Development and personnel from other functional groups in the early and late phase development of parenteral, topical and ophthalmic drug products.Plan, coordinate, supervise and monitor the manufacture of drug formulations for preformulation, formulation optimization and exploratory stability studies, preclinical pharmacokinetics, toxicology and pharmacology studies and analytical and microbiological method suitability studies and validations.Author, co-author, review and/or approve Technical Development Plans, Technical Reports, Standard Operating Procedures, Feasibility Evaluation Reports, Clinical Service Form Development Reports, Final Market Image Feasibility Assessment Reports, Technology Transfers, Manufacturing Instructions and Manufacturing Process Transfer Protocols.Author, co-author, review and approve CMC sections of regulatory submission documents, regulatory responses, briefing packages, amendments and supplements.Provide product support for drug products from early stage research through development, approval and post-approval.
  • Alcon
    Senior Scientist - Ophthalmic Formulation Development
    Alcon 2011 - Nov 2016
    Fort Worth, Texas
    R&D Pharmaceutical Products and Technology DevelopmentPlanned, conducted and monitored formulation research and development activities and represented PPTD Pharmaceutics on project teams in the development of topical ophthalmic drug products.Manufactured drug formulations for exploratory preformulation, formulation optimization and stability studies, preclinical pharmacokinetics, toxicology and pharmacology screening and analytical and microbiological method suitability studies and validations.Utilized solid state and other analytical techniques including XRPD, TGA, DSC, Raman spectroscopy, particle size analysis, viscometry, rheology, HPLC and UPLC to characterize new drug candidates and drug products. Wrote technical reports, SOPs and technical transfers and authored relevant sections of regulatory submission documents, regulatory responses, briefing packages, amendments and supplements in support of project elevation from the candidate selection process to proof of concept studies and regulatory submissions.Provided product support for drug products from early stage research through development, approval and post-approval.
  • Alcon
    Senior Scientist - Glaucoma Formulation Research
    Alcon 2010 - 2011
    Fort Worth, Texas
    Alcon Research, Ltd.R&D PharmaceuticsPlanned, conducted and monitored formulation research activities and represented Pharmaceutics on Glaucoma Research project team in support of glaucoma research testing funnels for topical ophthalmic drug products.Manufactured drug formulations for exploratory preformulation and stability studies, preclinical Pharmacokinetics, Toxicology and Pharmacology screening and Analytical Chemistry and Microbiology method validations.Utilized physical and chemical analytical techniques to characterize new drug candidates and drug products.Wrote technical reports in support of material transfer agreements and project elevation from the candidate selection process to proof of concept studies.
  • Alcon
    Senior Scientist - Surgical Therapeutics Formulation Development
    Alcon 2004 - 2010
    Fort Worth, Texas
    Alcon Research, Ltd.R&D Formulation Development Surgical TherapeuticsPlanned, conducted and monitored formulation research activities and represented Formulation Development Surgical Therapeutics on project teams in the development of ophthalmic surgical drug products and medical devices (ophthalmic irrigating solutions and ophthalmic viscoelastic devices) and topical ophthalmic and otic drug products.Manufactured drug formulations for exploratory preformulation, formulation optimization and stability studies, preclinical Toxicology screening and Analytical Chemistry and Microbiology method validations.Wrote technical reports, SOPs and technical transfers and authored relevant CMC sections of regulatory submission documents, regulatory responses, briefing packages, amendments and supplements in support of new product registrations and product lifecycle management.Provided product support for drug products from early stage research through development, approval and post-approval.
  • Alcon
    Senior Scientist - Ophthalmic, Otic And Nasal Formulation Development
    Alcon Oct 2000 - 2004
    Fort Worth, Texas
    Alcon Research, Ltd.R&D Pharmaceutical SciencesPlanned, conducted and monitored formulation research activities and represented Pharmaceutical Sciences on project teams in the development of topical ophthalmic, otic and nasal drug products.Manufactured drug formulations for exploratory preformulation, formulation optimization and stability studies, preclinical Pharmacokinetics, Toxicology and Pharmacology screening and Analytical Chemistry and Microbiology method validations.Wrote technical reports, SOPs and technical transfers and authored relevant CMC sections of regulatory submission documents, regulatory responses, briefing packages, amendments and supplements in support of new product registration and product lifecycle management.Provided product support for drug products from early stage research through development, approval and post-approval.
  • Colorado State University
    Graduate Research Assistant
    Colorado State University 1996 - 2000
    Fort Collins, Colorado
    Department of ChemistryConducted research in synthetic organic and organometallic chemistry.Conducted computational and in vitro studies of the interactions of DNA with novel synthetic compounds.
  • Colorado State University
    Graduate Teaching Assistant
    Colorado State University 1994 - 1995
    Fort Collins, Colorado
    Department of ChemistryTaught undergraduate organic chemistry laboratory sections.Proctored and graded examinations and tutored undergraduate chemistry students.
  • Alcon
    Associate Scientist/Scientist
    Alcon 1989 - 1994
    Fort Worth, Texas
    Alcon Laboratories, Inc.R&D Pharmaceutics Research SupportPlanned, conducted and monitored preformulation research activities in the development of potential new drug candidates for the treatment of glaucoma, allergic conjunctivitis and inflammation.Conducted studies of the kinetics of degradation of potential new drug candidates.Manufactured drug formulations for exploratory preformulation and stability studies and preclinical Pharmacokinetics, Toxicology and Pharmacology screening.Developed exploratory analytical HPLC methods and performed chemical and physical analyses to characterize new drug candidates and drug products. Wrote technical reports and SOPs and authored relevant sections of IND submissions.

Joseph P. B. Skills

Ctms Biotechnology Drug Delivery Cro Drug Discovery Capa Chromatography Analytical Chemistry Clinical Development 21 Cfr Part 11 Drug Development Pharmaceutical Industry Fda Gmp Glp Sop Regulatory Affairs Regulatory Submissions Technology Transfer Validation Lc Ms Medical Devices Lims Life Sciences Hplc Lifesciences R&d

Joseph P. B. Education Details

Frequently Asked Questions about Joseph P. B.

What company does Joseph P. B. work for?

Joseph P. B. works for Lifecycle Biotechnologies, Lp

What is Joseph P. B.'s role at the current company?

Joseph P. B.'s current role is Product Development Scientist.

What is Joseph P. B.'s email address?

Joseph P. B.'s email address is jo****@****ail.com

What schools did Joseph P. B. attend?

Joseph P. B. attended University Of Florida, Colorado State University, University Of North Texas, Centre College.

What skills is Joseph P. B. known for?

Joseph P. B. has skills like Ctms, Biotechnology, Drug Delivery, Cro, Drug Discovery, Capa, Chromatography, Analytical Chemistry, Clinical Development, 21 Cfr Part 11, Drug Development, Pharmaceutical Industry.

Who are Joseph P. B.'s colleagues?

Joseph P. B.'s colleagues are Michelle Stahla-Quintana, Marissa Mattos, Anna Highsmith, Ronald Gohdes, Jarod Adcock, Logan N., Rachel Mitchell, Mba.

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