Experience

NKA Bio

• United States
• Biotechnology Research
• 1 - 100 Employee

• Chief Technology Officer - NKA Bio

  • Feb 2023 - Present



Acurx Pharmaceuticals, Inc.

• Head Of Operations

  • 2012 - Present



CSSi LifeSciences

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Vice President of Quality and CMC

  • 2021 - Present

• Head of CMC

  • Apr 2018 - Present

  Got start up company going.



Shock Therapeutics Biotech

• United States
• Biotechnology Research
• 1 - 100 Employee

• Chief Technology Officer - Shock Therapeutics Biotech., Inc

  • 2018 - Present



Optimum Development Technologies, LLC

• CEO

  • Jun 2017 - Present

• Founder and General Manager

  • May 2017 - Sep 2019

  Vaccines; Protein Therapeutics; Synthetic Peptides; Cell Therapies; Reagents; Drugs; Parenterals; Enterics; Topicals; Sublinguals; Inhalents; Oculars; Veterinary ProductsCost Modeling; Process Modeling; Quality Systems Building and Management; Project Management; Process Validation; Fermentation; Cell Culture; Virus Production; Filtration; Chromatography; Extractions; Formulations; Packaging; Supply Management; Analytical Development; Analytical Validation; RISK Assessment; Deviation Resolution; CAPAs; Relocations; Disaster Recovery Show less



Acurx Pharmaceuticals Inc

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director of Manufacturing (CMC and Quality)

  • Jan 2013 - Present



AdvisoryCloud

• United States
• Business Consulting and Services
• 500 - 600 Employee

• Advisor

  • Dec 2019 - Present



RRD International

• Rockville, Maryland

• Senior Technical Advisor

  • Oct 2012 - 2017

  Senior position reporting to CEO. Provide leadership to project teams and partners in all areas of product development, especially: Planning and Logistics Chemistry, Manufacturing and Controls Quality Systems Quality Control Multi-National Regulations and Compliance Cost Control and Modeling Finance and Business Development Process and Regulatory Disaster Recovery Product and Process Design Contracting, Auditing and Budgeting Senior position reporting to CEO. Provide leadership to project teams and partners in all areas of product development, especially: Planning and Logistics Chemistry, Manufacturing and Controls Quality Systems Quality Control Multi-National Regulations and Compliance Cost Control and Modeling Finance and Business Development Process and Regulatory Disaster Recovery Product and Process Design Contracting, Auditing and Budgeting



Salamandra LLC

• Bethesda, Maryland

• Senior Consultant - Biologics, Operations and CMC

  • 2008 - Oct 2012

  Responsible for all biologics and cellular products contracts. Regulatory lead for several international projects. Provided embedded leadership in operations, manufacturing, quality and regulatory affairs to clients in various stages of product approval. Built Quality System for Salamandra and several clients, including several ASAMRIID sites. Brought several new clients to Salamandra generating significant income. See website at www.salamandra.net Responsible for all biologics and cellular products contracts. Regulatory lead for several international projects. Provided embedded leadership in operations, manufacturing, quality and regulatory affairs to clients in various stages of product approval. Built Quality System for Salamandra and several clients, including several ASAMRIID sites. Brought several new clients to Salamandra generating significant income. See website at www.salamandra.net



Celsis

• Vice President Product Operations

  • 2007 - 2008

  Responsible for all facets of manufacturing and product quality. Automated cellular products methods. Managed all personnel in products division. Brought new products to market. Developed marketing strategies and materials for products. Worked with sales team to close major deals and adjust production schedules to meet changing demands. Determined value of vast inventory and developed schemes for moving high-value products and deleting low-value products. Responsible for all facets of manufacturing and product quality. Automated cellular products methods. Managed all personnel in products division. Brought new products to market. Developed marketing strategies and materials for products. Worked with sales team to close major deals and adjust production schedules to meet changing demands. Determined value of vast inventory and developed schemes for moving high-value products and deleting low-value products.



Cambrex

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Head of Commercial Operation

  • 2006 - 2008

  Responsible for all contracts, project management, customer service, sales closing, resource planning, cost controls and client development. Coordinated all operational activities and responsible for bottom line. Worked with General Manager to prepare Bio site for acquisition and then stayed through turn-over to Lonza. Responsible for all contracts, project management, customer service, sales closing, resource planning, cost controls and client development. Coordinated all operational activities and responsible for bottom line. Worked with General Manager to prepare Bio site for acquisition and then stayed through turn-over to Lonza.



Hitachi Chemical Advanced Therapeutics Solutions, LLC

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director Manufacturing and Operations

  • 2004 - 2006

  In charge of all operations on East and West coast for T-cell and other cellular therapeutic products. Provided consulting services to other companies in cell therapy industry. In charge of all operations on East and West coast for T-cell and other cellular therapeutic products. Provided consulting services to other companies in cell therapy industry.



Biosynexus Incorporated

• Biotechnology
• 1 - 100 Employee

• Vice President Product Operations

  • 2002 - 2004

  Responsible for two recombinant therapies in vaccine/antibiotic area. Submitted INDs and updates. Managed all CMOs, CROs and CLOs. Negotiated sale of products. Responsible for two recombinant therapies in vaccine/antibiotic area. Submitted INDs and updates. Managed all CMOs, CROs and CLOs. Negotiated sale of products.



Biologics Consulting

• United States
• Biotechnology
• 1 - 100 Employee

• Consultant - Operations and CMC

  • 2001 - 2002

  Senior Consultant working on multi-national development and regulatory approval projects. This includes a major meningitis project for Gates Foundation (PATH) - qualifying, contracting and managing contractors and vendors on 5 continents. Senior Consultant working on multi-national development and regulatory approval projects. This includes a major meningitis project for Gates Foundation (PATH) - qualifying, contracting and managing contractors and vendors on 5 continents.



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Plant Manager

  • 1999 - 2001

  Vaccines manufacturing. Responsible for 9 departments over three sites. Member of Baxter Global Quality and Manufacturing Management Teams. Resolved very large number of 483 observations, then brought plant back through successful re-inspection and approval. Increased output by 50% while lowering unit costs 25%. Stopped high employee attrition rate. Acquired property for new campus. Vaccines manufacturing. Responsible for 9 departments over three sites. Member of Baxter Global Quality and Manufacturing Management Teams. Resolved very large number of 483 observations, then brought plant back through successful re-inspection and approval. Increased output by 50% while lowering unit costs 25%. Stopped high employee attrition rate. Acquired property for new campus.



Protein Polymer Technologies

• Director of Manufacturing

  • 1996 - 1999

  Responsible for all development, production, quality and CMC functions. Built compliant facility to manufacture clinical recombinant biomaterials with device designation. Managed significant growth in company then led effort to divest products. Responsible for all development, production, quality and CMC functions. Built compliant facility to manufacture clinical recombinant biomaterials with device designation. Managed significant growth in company then led effort to divest products.



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• Senior Development Scientist

  • 1991 - 1996

  Led Regulatory Teams Major Engineering and Process Project Management New Technology Development Deviation Resolution and CAPA Management Process Development Site Planning Led Regulatory Teams Major Engineering and Process Project Management New Technology Development Deviation Resolution and CAPA Management Process Development Site Planning



Berlex Biosciences

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Manager of Development

  • 1985 - 1989

  Formerly Codon Formerly Codon



Cetus

• Manager of Manufacturing

  • 1981 - 1985

  Lead upstream and downstream production operations for first approved biotech manufacturing facility. Established quality systems and trained all staff. Led all optimization and investigation teams. Lead upstream and downstream production operations for first approved biotech manufacturing facility. Established quality systems and trained all staff. Led all optimization and investigation teams.