Experience

Harmony Baby Nutrition

• United States
• Food and Beverage Services
• 1 - 100 Employee

• Chief Scientific Officer

  • Jan 2018 - Present

  harmonybabynutrition.com Saving & improving babies lives around the world harmonybabynutrition.com Saving & improving babies lives around the world



SCHAUER BIOLOGICS CONSULTING, LLC

• United States
• Pharmaceutical Manufacturing

• Principal Consultant

  • May 2013 - Present

  • Strategic planning and tactical support for process development and manufacturing of: - Recombinant therapeutic protein products. - Recombinant food products. - LBP (live biotherapeutic) products. • Expert in precision fermentation development for recombinant foods. • Evaluation of internal manufacturing processes. • Evaluation and selection of external CMOs and CROs: - Authoring, issuing, and… Show more • Strategic planning and tactical support for process development and manufacturing of: - Recombinant therapeutic protein products. - Recombinant food products. - LBP (live biotherapeutic) products. • Expert in precision fermentation development for recombinant foods. • Evaluation of internal manufacturing processes. • Evaluation and selection of external CMOs and CROs: - Authoring, issuing, and tracking of Request for Proposals (RFPs). - Evaluation and selection of CMOs and CROs based on issued proposals. - CMO\CRO site selection audits. - Oversight and management of interactions with selected CMOs\CROs. • Leading of biologics: manufacturing, process development, research, and project\program\portfolio management teams. • Authoring of CMC reports, and CMC sections of regulatory filing. Show less • Strategic planning and tactical support for process development and manufacturing of: - Recombinant therapeutic protein products. - Recombinant food products. - LBP (live biotherapeutic) products. • Expert in precision fermentation development for recombinant foods. • Evaluation of internal manufacturing processes. • Evaluation and selection of external CMOs and CROs: - Authoring, issuing, and… Show more • Strategic planning and tactical support for process development and manufacturing of: - Recombinant therapeutic protein products. - Recombinant food products. - LBP (live biotherapeutic) products. • Expert in precision fermentation development for recombinant foods. • Evaluation of internal manufacturing processes. • Evaluation and selection of external CMOs and CROs: - Authoring, issuing, and tracking of Request for Proposals (RFPs). - Evaluation and selection of CMOs and CROs based on issued proposals. - CMO\CRO site selection audits. - Oversight and management of interactions with selected CMOs\CROs. • Leading of biologics: manufacturing, process development, research, and project\program\portfolio management teams. • Authoring of CMC reports, and CMC sections of regulatory filing. Show less



Avaxia Biologics

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Vice President, Technical Operations

  • Jun 2013 - Dec 2015

  • Successfully re-developed robust and cost effective Phase 2 ready manufacturing processes for a unique gut stable, orally delivered, polyclonal antibody product (AVX-470) used to treat ulcerative colitis and crohn's disease. - Required the successful implementation of creative food-grade intermediary processing of a natural product raw material. - Required the development of a creative, robust and cost effective affinity purification process. - Required the successful… Show more • Successfully re-developed robust and cost effective Phase 2 ready manufacturing processes for a unique gut stable, orally delivered, polyclonal antibody product (AVX-470) used to treat ulcerative colitis and crohn's disease. - Required the successful implementation of creative food-grade intermediary processing of a natural product raw material. - Required the development of a creative, robust and cost effective affinity purification process. - Required the successful development of a creative enterically coated microparticle Drug Product for oral drug delivery. • Successfully identified, selected, and oversaw natural product raw material suppliers. • Successfully identified and selected food grade intermediary processors, GMP Drug Substance and GMP Drug Product contract manufacturers. • Successfully obsoleted an internally focused quality system and implemented an externally focused quality system that was specifically designed to take advantage of and oversee vendor’s quality systems. • Responsible for Technical Operations within the company, which included all aspects of Process Development, Manufacturing, Quality and Program Management. • Reported to the CEO, and was a member of Avaxia’s senior management team, which was responsible for developing and implementing Avaxia’s overall strategic plan. • Responsible for developing and implementing the company’s proprietary antibody manufacturing technology platform for orally administered gut targeted therapies. • Responsible for ensuring CMC regulatory compliance. Show less • Successfully re-developed robust and cost effective Phase 2 ready manufacturing processes for a unique gut stable, orally delivered, polyclonal antibody product (AVX-470) used to treat ulcerative colitis and crohn's disease. - Required the successful implementation of creative food-grade intermediary processing of a natural product raw material. - Required the development of a creative, robust and cost effective affinity purification process. - Required the successful… Show more • Successfully re-developed robust and cost effective Phase 2 ready manufacturing processes for a unique gut stable, orally delivered, polyclonal antibody product (AVX-470) used to treat ulcerative colitis and crohn's disease. - Required the successful implementation of creative food-grade intermediary processing of a natural product raw material. - Required the development of a creative, robust and cost effective affinity purification process. - Required the successful development of a creative enterically coated microparticle Drug Product for oral drug delivery. • Successfully identified, selected, and oversaw natural product raw material suppliers. • Successfully identified and selected food grade intermediary processors, GMP Drug Substance and GMP Drug Product contract manufacturers. • Successfully obsoleted an internally focused quality system and implemented an externally focused quality system that was specifically designed to take advantage of and oversee vendor’s quality systems. • Responsible for Technical Operations within the company, which included all aspects of Process Development, Manufacturing, Quality and Program Management. • Reported to the CEO, and was a member of Avaxia’s senior management team, which was responsible for developing and implementing Avaxia’s overall strategic plan. • Responsible for developing and implementing the company’s proprietary antibody manufacturing technology platform for orally administered gut targeted therapies. • Responsible for ensuring CMC regulatory compliance. Show less



Inspiration Biopharmaceuticals

• Biotechnology Research

• Vice President, Process Sciences

  • Jun 2012 - Jun 2013

  • Directly accountable for overall CMC leadership of the Phase III OBI-1 program (recombinant porcine factor VIII product for the treatment of serious bleeding episodes in patients with acquired hemophilia-A), including all aspects of Drug Substance and Drug Product development necessary for commercialization of the product. - OBI-1 was successfully commercialized and is currently licensed to Baxalta under the brand name OBIZUR. - Directly accountable for the overall CMC… Show more • Directly accountable for overall CMC leadership of the Phase III OBI-1 program (recombinant porcine factor VIII product for the treatment of serious bleeding episodes in patients with acquired hemophilia-A), including all aspects of Drug Substance and Drug Product development necessary for commercialization of the product. - OBI-1 was successfully commercialized and is currently licensed to Baxalta under the brand name OBIZUR. - Directly accountable for the overall CMC leadership of a Phase III recombinant human factor IX product for congenital hemophilia-B, including all aspects of Drug Substance and Drug Product development necessary for commercialization of the product. - The Factor IX product was successfully commercialized and is currently licensed to Emergent BioSolutions under the brand name IXinity. • Reported to the CEO and was a member of Inspiration’s Executive Management Team, responsible and accountable for Inspiration’s technical challenges and accomplishments. • Responsible for evaluation of process development, protein manufacturing, characterization, optimization, and manufacturing technologies. • Responsible for the definition and implementation of process strategies in both clinical and commercial settings. Show less • Directly accountable for overall CMC leadership of the Phase III OBI-1 program (recombinant porcine factor VIII product for the treatment of serious bleeding episodes in patients with acquired hemophilia-A), including all aspects of Drug Substance and Drug Product development necessary for commercialization of the product. - OBI-1 was successfully commercialized and is currently licensed to Baxalta under the brand name OBIZUR. - Directly accountable for the overall CMC… Show more • Directly accountable for overall CMC leadership of the Phase III OBI-1 program (recombinant porcine factor VIII product for the treatment of serious bleeding episodes in patients with acquired hemophilia-A), including all aspects of Drug Substance and Drug Product development necessary for commercialization of the product. - OBI-1 was successfully commercialized and is currently licensed to Baxalta under the brand name OBIZUR. - Directly accountable for the overall CMC leadership of a Phase III recombinant human factor IX product for congenital hemophilia-B, including all aspects of Drug Substance and Drug Product development necessary for commercialization of the product. - The Factor IX product was successfully commercialized and is currently licensed to Emergent BioSolutions under the brand name IXinity. • Reported to the CEO and was a member of Inspiration’s Executive Management Team, responsible and accountable for Inspiration’s technical challenges and accomplishments. • Responsible for evaluation of process development, protein manufacturing, characterization, optimization, and manufacturing technologies. • Responsible for the definition and implementation of process strategies in both clinical and commercial settings. Show less



Hospira

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Director: Process Development, Global Biologics R&D

  • Mar 2011 - Jun 2012

  • Successfully managed Drug Substance and Drug Product process development activities associated with Hospira’s portfolio of biosimilar products. • Successfully provided strategic leadership to improve Global Biologics Process Development capabilities including enhancing CMC planning and execution competence. • Successfully provided direct Global oversight of Drug Substance and Drug Product technical organizations located in Lake Forest IL, Chennai India, and Adelaide Australia. •… Show more • Successfully managed Drug Substance and Drug Product process development activities associated with Hospira’s portfolio of biosimilar products. • Successfully provided strategic leadership to improve Global Biologics Process Development capabilities including enhancing CMC planning and execution competence. • Successfully provided direct Global oversight of Drug Substance and Drug Product technical organizations located in Lake Forest IL, Chennai India, and Adelaide Australia. • Directly responsible for all biologics process development associated with Hospira’s “One-2-One” Global Biologics contract manufacturing. Show less • Successfully managed Drug Substance and Drug Product process development activities associated with Hospira’s portfolio of biosimilar products. • Successfully provided strategic leadership to improve Global Biologics Process Development capabilities including enhancing CMC planning and execution competence. • Successfully provided direct Global oversight of Drug Substance and Drug Product technical organizations located in Lake Forest IL, Chennai India, and Adelaide Australia. •… Show more • Successfully managed Drug Substance and Drug Product process development activities associated with Hospira’s portfolio of biosimilar products. • Successfully provided strategic leadership to improve Global Biologics Process Development capabilities including enhancing CMC planning and execution competence. • Successfully provided direct Global oversight of Drug Substance and Drug Product technical organizations located in Lake Forest IL, Chennai India, and Adelaide Australia. • Directly responsible for all biologics process development associated with Hospira’s “One-2-One” Global Biologics contract manufacturing. Show less



Millipore

• India
• Appliances, Electrical, and Electronics Manufacturing

• Director: DSP R&D

  • Oct 2006 - Mar 2011

  Director, DSP (down-stream processing) Research and Development: • Responsible for scientific and managerial leadership of a 120 person R&D organization with a $20M annual budget. The DSP R&D Department was organized into four independent functional areas consisting of Purification Development, BioSafety Development, Mobius (disposables) Development, and DSP Research. • Among others, innovative products such as Viresolve® Pro and Pro+, ChromaSorb™, ProResS, and ProSep® Ultra Plus… Show more Director, DSP (down-stream processing) Research and Development: • Responsible for scientific and managerial leadership of a 120 person R&D organization with a $20M annual budget. The DSP R&D Department was organized into four independent functional areas consisting of Purification Development, BioSafety Development, Mobius (disposables) Development, and DSP Research. • Among others, innovative products such as Viresolve® Pro and Pro+, ChromaSorb™, ProResS, and ProSep® Ultra Plus were released to Manufacturing (RTM) during my tenure. In addition, new innovative\disruptive sterilizing filtration technologies based on “electrospin” nanofiber methodologies were initiated under my direction. Director, Technology and Pre-Development: • Responsible for scientific and managerial leadership of the Technology and Pre-development department (T&PD). This Creativity\Innovation based group consisted of approximately 50 free thinking A.S., B.S., M.S., and Ph.D. level Scientists and Engineers organized into three independent innovation groups: Expression Technologies, Separation Technologies, and Process Analytical Technologies ($10M annual budget). • Responsible for identifying\developing innovative and creative new technologies and for providing the entry point of projects and products into the product development pipeline. “Smart Polymer” development was initiated during my direction of the T&PD group. • Actively involved in redefinition of the stage gate process used to monitor and regulate the progress of innovation projects in the pre-development pipeline. • Successfully played an active role in defining the technology innovation strategy of the Bioprocess division. Show less Director, DSP (down-stream processing) Research and Development: • Responsible for scientific and managerial leadership of a 120 person R&D organization with a $20M annual budget. The DSP R&D Department was organized into four independent functional areas consisting of Purification Development, BioSafety Development, Mobius (disposables) Development, and DSP Research. • Among others, innovative products such as Viresolve® Pro and Pro+, ChromaSorb™, ProResS, and ProSep® Ultra Plus… Show more Director, DSP (down-stream processing) Research and Development: • Responsible for scientific and managerial leadership of a 120 person R&D organization with a $20M annual budget. The DSP R&D Department was organized into four independent functional areas consisting of Purification Development, BioSafety Development, Mobius (disposables) Development, and DSP Research. • Among others, innovative products such as Viresolve® Pro and Pro+, ChromaSorb™, ProResS, and ProSep® Ultra Plus were released to Manufacturing (RTM) during my tenure. In addition, new innovative\disruptive sterilizing filtration technologies based on “electrospin” nanofiber methodologies were initiated under my direction. Director, Technology and Pre-Development: • Responsible for scientific and managerial leadership of the Technology and Pre-development department (T&PD). This Creativity\Innovation based group consisted of approximately 50 free thinking A.S., B.S., M.S., and Ph.D. level Scientists and Engineers organized into three independent innovation groups: Expression Technologies, Separation Technologies, and Process Analytical Technologies ($10M annual budget). • Responsible for identifying\developing innovative and creative new technologies and for providing the entry point of projects and products into the product development pipeline. “Smart Polymer” development was initiated during my direction of the T&PD group. • Actively involved in redefinition of the stage gate process used to monitor and regulate the progress of innovation projects in the pre-development pipeline. • Successfully played an active role in defining the technology innovation strategy of the Bioprocess division. Show less



Biogen Idec

• Director: Cambridge Manufacturing Sciences

  • Apr 2002 - Oct 2006

  Director, Cambridge Manufacturing Sciences: • Responsible for scientific and managerial leadership of approximately 20 A.S., B.S., M.S., and Ph.D. level Scientists and Engineers organized into three independent groups: Cell Culture and Cell Banking, Purification and AFO, Data Systems and Analysis. This group oversaw the tech transfer of manufacturing processes into Biogen Idec’s Cambridge Manufacturing facility (Drug Substance) and AFO facility (Drug Product). Tech Transfer is a matrix… Show more Director, Cambridge Manufacturing Sciences: • Responsible for scientific and managerial leadership of approximately 20 A.S., B.S., M.S., and Ph.D. level Scientists and Engineers organized into three independent groups: Cell Culture and Cell Banking, Purification and AFO, Data Systems and Analysis. This group oversaw the tech transfer of manufacturing processes into Biogen Idec’s Cambridge Manufacturing facility (Drug Substance) and AFO facility (Drug Product). Tech Transfer is a matrix management oriented function that requires integration of numerous disciplines including: Process Development, QC, QA, Regulatory, Documentation, Facilities, Manufacturing, and many others. • Responsible for oversight of formal investigations associated with major deviations encountered during commercial and clinical manufacturing campaigns (both drug substance and drug product). Responsibilities include presentation of investigation results to global regulatory inspectors and auditors. • Responsible for data mining and analysis of manufacturing data for assessment of process conformity. Senior Program Manager, Program and Alliance Management: • Program Manager for four early Development Programs, including one alliance program. • Responsible for coordination of program related interdepartmental activities, development of integrated timelines and integrated development plans. Show less Director, Cambridge Manufacturing Sciences: • Responsible for scientific and managerial leadership of approximately 20 A.S., B.S., M.S., and Ph.D. level Scientists and Engineers organized into three independent groups: Cell Culture and Cell Banking, Purification and AFO, Data Systems and Analysis. This group oversaw the tech transfer of manufacturing processes into Biogen Idec’s Cambridge Manufacturing facility (Drug Substance) and AFO facility (Drug Product). Tech Transfer is a matrix… Show more Director, Cambridge Manufacturing Sciences: • Responsible for scientific and managerial leadership of approximately 20 A.S., B.S., M.S., and Ph.D. level Scientists and Engineers organized into three independent groups: Cell Culture and Cell Banking, Purification and AFO, Data Systems and Analysis. This group oversaw the tech transfer of manufacturing processes into Biogen Idec’s Cambridge Manufacturing facility (Drug Substance) and AFO facility (Drug Product). Tech Transfer is a matrix management oriented function that requires integration of numerous disciplines including: Process Development, QC, QA, Regulatory, Documentation, Facilities, Manufacturing, and many others. • Responsible for oversight of formal investigations associated with major deviations encountered during commercial and clinical manufacturing campaigns (both drug substance and drug product). Responsibilities include presentation of investigation results to global regulatory inspectors and auditors. • Responsible for data mining and analysis of manufacturing data for assessment of process conformity. Senior Program Manager, Program and Alliance Management: • Program Manager for four early Development Programs, including one alliance program. • Responsible for coordination of program related interdepartmental activities, development of integrated timelines and integrated development plans. Show less



EMD Pharmaceuticals

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Manager

  • Oct 1999 - Apr 2002

  EMD/LEXIGEN PHARMACEUTICALS, Lexington, MA (a subsidiary of E MERCK, KGaA, Darmstadt ) • Global CMC Team Leader, responsible for matrix management of an international group, which oversaw all process development and manufacturing activities, associated with the company’s two biologics programs (KS-IL2 and 1418-IL2). • Successfully managed interactions with Contract Manufacturing Organizations. • Helped establish QC operations within Lexigen, and played a leadership role in coordinating… Show more EMD/LEXIGEN PHARMACEUTICALS, Lexington, MA (a subsidiary of E MERCK, KGaA, Darmstadt ) • Global CMC Team Leader, responsible for matrix management of an international group, which oversaw all process development and manufacturing activities, associated with the company’s two biologics programs (KS-IL2 and 1418-IL2). • Successfully managed interactions with Contract Manufacturing Organizations. • Helped establish QC operations within Lexigen, and played a leadership role in coordinating QC functions with E Merck. Show less EMD/LEXIGEN PHARMACEUTICALS, Lexington, MA (a subsidiary of E MERCK, KGaA, Darmstadt ) • Global CMC Team Leader, responsible for matrix management of an international group, which oversaw all process development and manufacturing activities, associated with the company’s two biologics programs (KS-IL2 and 1418-IL2). • Successfully managed interactions with Contract Manufacturing Organizations. • Helped establish QC operations within Lexigen, and played a leadership role in coordinating… Show more EMD/LEXIGEN PHARMACEUTICALS, Lexington, MA (a subsidiary of E MERCK, KGaA, Darmstadt ) • Global CMC Team Leader, responsible for matrix management of an international group, which oversaw all process development and manufacturing activities, associated with the company’s two biologics programs (KS-IL2 and 1418-IL2). • Successfully managed interactions with Contract Manufacturing Organizations. • Helped establish QC operations within Lexigen, and played a leadership role in coordinating QC functions with E Merck. Show less



Wyeth Biotech

• Principal Scientist/Lab Head, Microbial Fermentation and Recovery

  • May 1986 - Jun 1999

  GENETICS INSTITUTE/ WYETH, Cambridge/Andover, MA Manager, DiscoverEase™ Gene Expression: • Played a leadership role in strategic management of the DiscoverEase™ functional genomics program. • Successfully managed a high-throughput mammalian gene expression group responsible for production of the DiscoverEase™ protein and cDNA commercial products. • Successfully established a functional GLP production suite. Successfully introduced compliance appropriate documentation… Show more GENETICS INSTITUTE/ WYETH, Cambridge/Andover, MA Manager, DiscoverEase™ Gene Expression: • Played a leadership role in strategic management of the DiscoverEase™ functional genomics program. • Successfully managed a high-throughput mammalian gene expression group responsible for production of the DiscoverEase™ protein and cDNA commercial products. • Successfully established a functional GLP production suite. Successfully introduced compliance appropriate documentation procedures including batch records, SOP’s, and material transfer records. Principal Scientist\Lab Head, Microbial Fermentation and Recovery: • Successfully established and validated numerous master and working cell banks. • Successfully developed and optimized numerous fermentation processes resulting in high expression levels at high cell densities. Many of these processes were used to produce human pharmaceuticals under "cGMP" conditions for phase I, phase II and phase III clinical studies and for production of commercial drug substance (rhIL-11, Neumega). • Successfully developed downstream processing steps including cell harvest, product release, clarification and refolding. • Responsible for scale up of fermentation and downstream processes, to the appropriate manufacturing scales. • Responsible for transfer of fully developed processes to Clinical and Commercial Manufacturing. • Developed procedures for large scale protein refolding. • Successfully established, qualified, and validated fermentation and recovery specific assays, including quantitative protein assays from complex mixtures such as whole cell lysates. • Successfully generated research quantities of recombinant proteins to internal and external groups. These ranged from crude cell lysates to gram quantities of homogeneous refolded proteins. • Successfully managed A.S., B.S., M.S., and Ph.D. level Development Scientists and Engineers, as well as Manufacturing Personnel Show less GENETICS INSTITUTE/ WYETH, Cambridge/Andover, MA Manager, DiscoverEase™ Gene Expression: • Played a leadership role in strategic management of the DiscoverEase™ functional genomics program. • Successfully managed a high-throughput mammalian gene expression group responsible for production of the DiscoverEase™ protein and cDNA commercial products. • Successfully established a functional GLP production suite. Successfully introduced compliance appropriate documentation… Show more GENETICS INSTITUTE/ WYETH, Cambridge/Andover, MA Manager, DiscoverEase™ Gene Expression: • Played a leadership role in strategic management of the DiscoverEase™ functional genomics program. • Successfully managed a high-throughput mammalian gene expression group responsible for production of the DiscoverEase™ protein and cDNA commercial products. • Successfully established a functional GLP production suite. Successfully introduced compliance appropriate documentation procedures including batch records, SOP’s, and material transfer records. Principal Scientist\Lab Head, Microbial Fermentation and Recovery: • Successfully established and validated numerous master and working cell banks. • Successfully developed and optimized numerous fermentation processes resulting in high expression levels at high cell densities. Many of these processes were used to produce human pharmaceuticals under "cGMP" conditions for phase I, phase II and phase III clinical studies and for production of commercial drug substance (rhIL-11, Neumega). • Successfully developed downstream processing steps including cell harvest, product release, clarification and refolding. • Responsible for scale up of fermentation and downstream processes, to the appropriate manufacturing scales. • Responsible for transfer of fully developed processes to Clinical and Commercial Manufacturing. • Developed procedures for large scale protein refolding. • Successfully established, qualified, and validated fermentation and recovery specific assays, including quantitative protein assays from complex mixtures such as whole cell lysates. • Successfully generated research quantities of recombinant proteins to internal and external groups. These ranged from crude cell lysates to gram quantities of homogeneous refolded proteins. • Successfully managed A.S., B.S., M.S., and Ph.D. level Development Scientists and Engineers, as well as Manufacturing Personnel Show less