Go to Website
  • en
  • de

Brenden H.

Director of Process Development

Washington, United States

Experience

Aug 2024 - Present
1 year 5 months
Rockville, 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 month
Rockville, 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 month
Rockville, 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 months
Rockville, 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 year
Richmond, 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 month
Austin, 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
Native

Education

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

Need a freelancer? Find your match in seconds.
Try FRATCH GPT
More actions

Similar Freelancers

Discover other experts with similar qualifications and experience

Thomas F.

Operational Excellence Consultant

View Profile
Jovan J.

CSV Manager, Technical Engineering

View Profile
Mehrdad S.

Supervisor of Formulation and Manufacturing

View Profile
Norbert H.

Interim Project Manager Ramp Up Pilot Facility

View Profile
Juergen S.

Manager Manufacturing Operations USP

View Profile
Oliver W.

Project Manager & Lead Auditor

View Profile
Marcel P.

interim Head of Production, CAPA-Manager, Expert in Process Optimization

View Profile
Timur G.

Senior Quality Project Expert and Consultant in the Pharmaceutical Industry

View Profile
Anja Ż.

Senior Project Manager & Consultant for Quality, Processes and Transformation

View Profile
Hans S.

interim Manager & Medical Device Expert

View Profile
Dana G.

Managing Director & Consultant

View Profile
Mac C.

CTO / Retired

View Profile
Olaf S.

Interim Manager and Consultant for Purchasing/Supply Chain Management

View Profile
Salome L.

Senior Program Manager Transformation Office & Consultant

View Profile
Martin S.

Senior Quality Executive, Consultant & Interim Manager in Technology companies

View Profile
Andreas S.

Interim Head of Risk Management and Usability

View Profile
Jefferson S.

QA Specialist

View Profile
Merve G.

Qualified Person

View Profile
Burcu P.

QA Validation/Qualification

View Profile
Ananda J.

Assistant Professor

View Profile
Dieudonné M.

PRRC, Quality and Regulatory Representative

View Profile
Dan C.

Delivery Director for Global Delivery Management Team

View Profile
Monika W.

Quality Specialist

View Profile
Ralf S.

Interim Manager, General Manager

View Profile
Erik Z.

Quality Management Consultant

View Profile
Klaus-dieter B.

Project Manager / E-Mobility Division

View Profile
Joseph A.

intacs Provisional Assessor AUTOMOTIVE SPICE®

View Profile
Rüdiger S.

Process optimization

View Profile
Lars O.

Founding Partner

View Profile
Seongdo C.

Freelance Data Annotater

View Profile
fratch Part of Bitkom logo
linkedIncrunchbaseyoutube
  • English
  • Deutsch

2025 © FRATCH.IO GmbH. All rights reserved.