Experience

DiaMedica Therapeutics Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Chief Technology Officer

  • Oct 2023 - Present

  DiaMedica Therapeutics is a clinical-stage biopharmaceutical company that is developing innovative treatments where there is significant unmet clinical need or where no current therapies are available with the focus on neurological and kidney diseases.



AmbarK Biopharma Consulting

• President

  • Feb 2023 - Present

  Germantown, Maryland, United States Trusted biopharma expert and business leader who builds and leads organizations focused on CMC development, with particular emphasis on Drug Product & Process Development and Delivery. Distinguished record of building cutting edge scientific capabilities, establishing and managing talented organizations, and nurturing vibrant cultures focused on innovation, collaboration and scientific problem solving. Establishes strategy and oversees development activities, ensuring they meet project… Show more Trusted biopharma expert and business leader who builds and leads organizations focused on CMC development, with particular emphasis on Drug Product & Process Development and Delivery. Distinguished record of building cutting edge scientific capabilities, establishing and managing talented organizations, and nurturing vibrant cultures focused on innovation, collaboration and scientific problem solving. Establishes strategy and oversees development activities, ensuring they meet project, business and budget targets. Brings deep insights and decision making experience gained from successful global licensure and life cycle management of life altering medicines and vaccines including ReblozylTM, BlincytoTM, ImfinziTM, LumoxitiTM, FlucelvaxTM, FluAdTM, and several other important medicines. - Strategy and oversight of CMC development for proteins, mRNA and sub-unit vaccine products - Inspire and lead top-performing teams and develop talent and culture. - Analyze and make high-stakes decisions in consultative manner with key executive stakeholders - Guide investment and business strategy and execution for in-house or partnered Development CMC Development | Biopharmaceuticals | Vaccines | mRNA | Technology Transfer | Innovation | Leader Show less



CSL

• Australia
• Biotechnology Research
• 700 & Above Employee

• VP, Head of Global Technical Development

  • Jul 2020 - Feb 2023

  North Carolina, United States Accountable leader for end-to-end CMC vaccine development activities for entire portfolio across 3 platforms: egg, cell culture and mRNA at 3 global locations. Lead a department of 150+ scientists and associates within the following functions: -Virology -Cell Culture & Purification Process Development -Formulation & Drug Product Development -Analytical Development & Stability -CMC Project Management -Lab Operations -Technology Transfer -Virus Manufacturing Pilot… Show more Accountable leader for end-to-end CMC vaccine development activities for entire portfolio across 3 platforms: egg, cell culture and mRNA at 3 global locations. Lead a department of 150+ scientists and associates within the following functions: -Virology -Cell Culture & Purification Process Development -Formulation & Drug Product Development -Analytical Development & Stability -CMC Project Management -Lab Operations -Technology Transfer -Virus Manufacturing Pilot Plant. Show less



Celgene

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Executive Director, Head of Biologics Drug Product Development

  • Jan 2018 - Jul 2020

  Summit, NJ Accountable for end-to-end Drug Product (DP) Development including formulation, DP process development, and technology transfer for the Celgene biologics portfolio -Responsible for the DP development function -Established two fully functioning development laboratories in NJ and CA. -Accelerated Development of ReblozylTM, culminating in successful licensure.



MedImmune

• United States
• Biotechnology Research
• 700 & Above Employee

• Director R&D

  • 2004 - Jan 2018

  Gaithersburg, Maryland, United States Responsible for Drug Product development including developability, formulation development, analytics, and combination product development. -Managed DP Development for over 25 proteins (antibodies, conjugates, novel molecules, multimeric proteins, biologic fixed dose combinations) from early stage to late stage, combination products in PFS and large volume infusion devices, lyophilized products. -Significant contributions to product development and troubleshooting resulting in… Show more Responsible for Drug Product development including developability, formulation development, analytics, and combination product development. -Managed DP Development for over 25 proteins (antibodies, conjugates, novel molecules, multimeric proteins, biologic fixed dose combinations) from early stage to late stage, combination products in PFS and large volume infusion devices, lyophilized products. -Significant contributions to product development and troubleshooting resulting in successful licensure of BlincytoTM, ImfinziTM, and LumoxitiTM Show less



Human Genome Sciences

• United States
• Biotechnology
• 400 - 500 Employee

• Section Head, Formulation & Analytical Development

  • 2001 - 2004

  Rockville, Maryland, United States Established a unit responsible for Formulation and Analytical Development for novel protein therapeutics and was responsible for Drug Product Development and supporting In-process analytics and stability



Wyeth BioPharma

• 1 - 100 Employee

• Sr Scientist, Analyical R&D

  • 1998 - 2001

  Pearl River, New York, United States - Bench scientist responsible for developing analytical methods for biopharmaceutical and small molecule drugs delivered using non conventional drug delivery systems - Lead investigator on clinical failures and FDA-mandated product recall of NorplantTM controlled delivery system