Schauer Biologics Consulting LLC. (SBC), provides strategic planning and tactical support for process development and manufacturing activities at startup and established recombinant protein biologics companies and at recombinant food companies.

Dr. Schauer, the Principal Consultant, is a versatile and accomplished executive scientist with a successful 30+ year record of innovative leadership, developing therapeutic biologic and recombinant food products. With a Ph.D. in Anaerobic Microbiology, Dr. Schauer also provides active consulting support for microbiome (live biotherapeutic) products. He is an expert on precision fermentation development.

At Avaxia Biologics, Dr. Schauer, was Senior VP of Technical Operations; where he was responsible for Process Development, Manufacturing, Quality and Program Management. In previous positions (Inspiration Biopharmaceuticals, Hospira, Millipore, Biogen Idec,  and Genetics Institute\Wyeth), Dr. Schauer held positions of increasing responsibility associated with biologics: technology, manufacturing, process development, research, and project\program\portfolio management.

Harmony Baby Nutrition - Chief Scientific Officer

• Oversight of scientific programs leading to the development of novel synthetic human breastmilk formulations, using recombinant DNA technology, precision fermentation, food grade processing, and product formulation technologies.

AVAXIA BIOLOGICS - SENIOR VICE PRESIDENT, TECHNICAL OPERATIONS

• Reported directly 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 Technical Operations within the company, which included all aspects of Process Development, Manufacturing, Quality and Program Management

• Responsible for developing and implementing the company’s proprietary antibody manufacturing technology platform for orally administered gut targeted therapies

  • 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  

• Responsible for ensuring CMC regulatory compliance

  • 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.

inspiration biopharmaceuticals - Vice President, Process Science

• 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

• Directly accountable for overall CMC leadership of the Phase III  recombinant porcine factor VIII product (OBI-1) 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 (IXinity) for treatment of 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.

hospira - Senior Director: Process Development, Global Biologics R&D

• 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, Adelaide Australia

• Directly responsible for all biologics process development associated with Hospira’s “One-2-One” Global Biologics contract manufacturing

MILLIPORE - Director: DOWN-STREAM PROCESSING (DSP) 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

• Innovative products such as Viresolve® Pro and Pro+, ChromaSorb™, ProResS, and ProSep® Ultra Plus were released to Manufacturing (RTM) during my tenure  

• New innovative\disruptive sterilizing filtration technologies based on “electrospin” nanofiber methodologies were initiated under my direction

MILLIPORE - Director: Technology and Pre-Development

• Responsible for scientific and managerial leadership of the Technology and Pre-development department (T&PD) with a $10M annual budget.  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  

• 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

BIOGEN IDEC - 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

BIOGEN IDEC -  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

• Project Manager: Research Operations

  • Responsible for managing numerous early-stage Neurobiology and Immunology oriented early research projects, including small molecule projects.  Responsibilities included project, resource and financial planning

  • Helped to guide and advised individual project leaders.  In addition, worked closely with members of Biogen Idec’s Research Management, Legal, Contract Management, Budget, and Finance groups

Genetics Institute\ Wyeth - Principal Scientist\Lab Head, Microbial Fermentation and Recovery

• Played a leadership role in strategic management of Product and Process Development at Genetics Institute (now Pfizer)

•  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

• Successfully devised methods used to overcome the physiological restraints associated with over-expression of heterologous gene products in recombinant microorganisms

• Invented generic procedures for the purification of inclusion bodies from recombinant microorganisms

• 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 group of up to ten A.S., B.S., M.S., and Ph.D. level Development Scientists and Engineers, as well as Manufacturing Personnel