Timothy Ingallinera

About Timothy Ingallinera

I enjoy working with all departments to ensure pharmaceutical products meet the needs of the market, its mechanism of action and toxicological profile. With over 20 years in the pharmaceutical industry, starting in the warehouse and working up to the head of formulation/biopharmaceutics at two small pharma company, I am driven to ensure the success of any project I am on. This usually means constant communication and staying approachable by anyone as to avoid delays and issues related to misunderstandings and miscommunication.This has lead me to work closely with people in systems and clinical pharmacology, biology, translational sciences, clinical, commercial, toxicology and marketing. I always like to find the end use of a formulation or product and ensure it is fit for purpose. I also have a lot of experience in analytical methods development and validation/qualification in GMP and GLP environments to support my CMC and non-CMC colleagues.I always ensure we are using the most up-to-date techniques, data analysis, and practices when I am on a project. This involves keeping up to date with guidances from all regulatory agencies, reading the newest journals, attending local and national meetings/workshops, and discussing with colleagues in the field. I am always looking to integrate novel approaches and data-driven decision making into my work.Key Skills:Formulation of solid dosage formsFormulation of sterile productsManufacturing and supply chainAnalytical developmentPhysical pharmacy/pre-formulationQuality controlIntellectual propertyRegulatory filingsPediatric medicationData analysis(programming, modelling and interpretation)

Experience

1. Director, Drug Product Development

   Scribe Therapeutics

   Oct 2023 — Present · Alameda, CA, US

   Leading a team to help develop novel gene therapies

Education

• University of South Carolina

  Bachelor of Science (BSc), Chemistry

Skills

• Physical Chemistry
• Solid State Characterization
• Due Diligence
• Validation
• Mass Spectrometry
• Regulatory Submissions
• Process Chemistry
• Pharmaceutics
• Analytical Chemistry
• Pharmaceutical Industry
• Pharmaceutical Development
• High-Performance Liquid Chromatography (Hplc)
• Data Visualization
• Gmp
• Ich Guidelines
• Biotechnology
• R
• Drug Development
• Statistical Data Analysis
• Electronic Common Technical Document (Ectd)
• Drug Delivery
• Hplc
• New Drug Application (Nda)
• Ind
• Formulation
• Product Development
• Technology Transfer
• Data Science
• Chemistry