Brenden H.
Director of Process Development
Experience
Aug 2024 - Present
1 year 4 monthsRockville, United States
Director of Process Development
On Demand Pharmaceuticals
- Lead the Process Development teams (Drug Substance and Drug Product) by providing leadership, guidance, and direction to scientific researchers e.g. professional development, experimental planning, experimental design, and data analysis
- Direct health-related research projects funded by Health and Human Services (HHS), Defense Advanced Research Projects Agency (DARPA) and the Office of Naval Research (ONR); responsible for staffing and budgeting considerations to complete milestones
- Sit on the R&D management team and provide strategic recommendations for ODP’s active pharmaceutical ingredient (API) portfolio
- Oversee development of chemical processes for the manufacture of regulatory starting materials, advanced intermediates, and APIs, including synthesis, purification and isolation using batch or continuous manufacturing platforms
- Oversee development of formulation/compounding processes for the manufacture of sterile injectables in compliance with 503a or 503b regulatory requirements
- Oversee technology transfer from process research and development group to manufacturing group for production of drug substance/drug product in compliance with cGMP requirements
- Develop project plans, while considering multiple scenarios, cost of goods, raw material availability, labor costs, capital expenditures, etc
- Author and review CMC sections of regulatory filings (including DMFs and ANDAs)
- Author and review scientific manuscripts for submission to peer-reviewed journals
- Identify and recommend intellectual property and/or trade secrets opportunities
- Present at national scientific meetings and conferences e.g. Commercializing Flow Chemistry Summit
Aug 2022 - Aug 2024
2 years 1 monthRockville, United States
Assoc. Director of Process Development
On Demand Pharmaceuticals
- Lead the Process Development teams (Drug Substance and Drug Product) by providing leadership, guidance, and direction to scientific researchers e.g. professional development, experimental planning, experimental design, and data analysis
- Direct health-related research projects funded by Health and Human Services (HHS), Defense Advanced Research Projects Agency (DARPA) and the Office of Naval Research (ONR); responsible for staffing and budgeting considerations to complete milestones
- Sit on the R&D management team and provide strategic recommendations for ODP’s active pharmaceutical ingredient (API) portfolio
- Oversee development of chemical processes for the manufacture of regulatory starting materials, advanced intermediates, and APIs, including synthesis, purification and isolation using batch or continuous manufacturing platforms
- Oversee development of formulation/compounding processes for the manufacture of sterile injectables in compliance with 503a or 503b regulatory requirements
- Oversee technology transfer from process research and development group to manufacturing group for production of drug substance/drug product in compliance with cGMP requirements
- Develop project plans, while considering multiple scenarios, cost of goods, raw material availability, labor costs, capital expenditures, etc
- Author and review CMC sections of regulatory filings (including DMFs and ANDAs)
- Author and review scientific manuscripts for submission to peer-reviewed journals
- Identify and recommend intellectual property and/or trade secrets opportunities
- Present at national scientific meetings and conferences e.g. Commercializing Flow Chemistry Summit
Aug 2021 - Aug 2022
1 year 1 monthRockville, United States
Principal Scientist
On Demand Pharmaceuticals
- Led the drug substance team – a five-person team comprising organic chemists and chemical engineers – in the development of chemical processes
- Provided technical guidance and professional development for four R&D team members
- Interfaced with Innovation team management (representatives from Analytical, Formulation, Engineering, and Integrated Analytics) to develop communication strategies, organizational plans, and technical plans
- Authored internal and external research reports for relevant stakeholders and government sponsors
- Managed relationships with external contractors and consultants
- Authored background and experimental claims for patent applications for the manufacture of cisatracurium besylate (WO2023086696A3) and midazolam (US20240109848A1)
Jul 2020 - Aug 2021
1 year 2 monthsRockville, United States
Senior Scientist
On Demand Pharmaceuticals
- Developed chemical processes, including synthesis, purification and isolation that can be translated from traditional batch chemistry to small form-factor modular continuous manufacturing platforms to produce kilogram quantities of material
- Characterized starting materials, intermediates, products, and process streams by UV-Vis, IR, Raman, DSC, TGA, TLC, HPLC, LC-MS, GC-MS, and/or NMR
- Assisted with regulatory submissions using ICH guidance, including drug master files and abbreviated new drug applications e.g. starting material risk assessments, specifications for key intermediates, impurity fate mapping studies, etc.
- Produced batch records and SOPs e.g. spill-response plan, chemical hygiene plan, etc.
- Trained scientists and junior scientists in experimental organic chemistry
Aug 2019 - Jul 2020
1 yearRichmond, United States
Post-Doctoral Fellow
Medicines for All Institute
- Responsible for the preparation and review of scientific research proposals, process development reports, and manuscripts
- Managed the preparation and distribution of stage gate materials for customer engagement
- Implemented organizational design and process improvements using project management tools to improve organization wide communication
- Collaborated closely with Chief Technical Officer and Senior Project Manager to provide daily project updates
- Assisted with the preparation of techno-economic analyses and cost of goods models
Aug 2014 - Aug 2019
5 years 1 monthAustin, United States
Graduate Research Assistant
The University of Texas at Austin
- Synthesized stereoisomeric sets of small molecules (e.g. both enantiomers of cis- and trans- diastereomers) via traditional organic methodologies and purified via standard purification methods (silica gel chromatography, preparative HPLC, crystallization, etc.)
- Performed stereoisomeric analyses (circular dichroism, UV-Vis, fluorescence spectroscopy, chiral chromatography, and NMR spectroscopy) for wide range of compounds to facilitate asymmetric reaction discovery
- Consulted and assisted in the development of the first commercial circular dichroism well-plate spectropolarimeter (in collaboration with Hinds Instruments Inc.)
Languages
English
NativeEducation
Aug 2014 - Aug 2019
The University of Texas at Austin
PhD · Chemistry · Austin, United States
The University of Texas at Austin
BS · Chemistry · Austin, United States
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