Expertise

• More than eight years in biopharmaceutical cGMP process development and manufacturing.
• cGMP production of recombinant proteins and monoclonal antibodies with cell cultures at large scale.
• cGMP production of biopharmaceuticals with microbial cultures at large scale bioreactors:
• Responsible for up and mid-stream process development (microbial, yeast, insect and mammalian cells) for the cGMP production of APIs (recombinant proteins, monoclonal antibodies and others).
• In depth experience in biotechnology transfer, bio-process development, process scale-up, process optimization and implementation for cGMP manufacturing within the highly regulated GMP manufacturing environment.
• Scientific and technical lead of multiple bio-therapeutic manufacturing and development programs (Phase I to commercial) for international clients according to established guidelines (ICH, FDA, EMEA, Health Canada).
• Up-stream and Mid-stream process development (microbial and mammalian), optimization and implementation; batch, fed-batch and perfusion processes; fermentation development.
• Bio process experience with stirred tank, airlift, multi vessel systems and disposable technology such as (Wave-bag and SUBs).
• Skilled with various cell retention devices for perfusion processes (internal spin filter, ATF, acoustic filter, settler).
• Experienced with mid-stream technology such as homogenization, filtration (TFF and dead-end), continuous centrifugation.
• cGMP Production of recombinant proteins and virae (Insect cells / baculovirus) at high-cell densities.
• Hands-on experience with bacteria, yeast, fungi and higher cells from cryo-vial to bioreactor.
• Pattern recognition; metabolic flux analysis; acquisition, evaluation, archiving of on- and off-line data.

Experience

Independent Consultant, Cambridge MA, Present

• Upstream consulting and technology transfer for a development stage biotechnology company.
• Provide scientific support to their cGMP production program for clinical trials.

QSV Biologics Ltd., Edmonton, Alberta, Canada, Senior Scientist, 2006 - 2009

• Process development upstream of an international GMP biologics contract manufacturer.
• Focus on mammalian cell culture and microbial fermentation services for the production of protein therapeutics for pre-clinical to Phase III human trials and early commercial supply.
• Up-mid-stream support for projects that covered the entire spectrum from microbial to mammalian processes (E.coli, Pichia pastoris, Insect cells, Hybridoma and CHO).
• Scientific and technical lead and troubleshooting during development phase, scale-up, engineering runs and cGMP manufacturing at scale, including cGMP preparation and documentation.
• Hands-on work with bioreactors and different cultures; training of junior personnel; selection and implementation of new methods and equipment.
• Contributed to planning and designing of a new multi-project facility with mammalian and microbial process capability at 2000-L scale.
• Brought a Pichia fermention to QSV and led process development and scale-up to cGMP manufacturing readiness within six month. Project was firm's first successful project from process development to manufacturing of Phase I material.
• Lead a cross-functional team to establish mammalian cell culture capability at QSV. This task entailed upgrading the upstream lab areas in process development, launching of manufacturing suites (upstream, pre- and post-viral MCC suites), sourcing process equipment.

DSM Biologics, Montreal, Quebec, Canada, Senior Scientist, Cell Culture, 2001 - 2006

• Senior scientist for a multi-national contract cGMP manufacturing organization specializing in the production of biopharmaceuticals using mammalian cell culture processes for pre-clinical to Phase III human trials and early commercial supply.
• Responsible for a wide variety projects of mammalian fed-batch and perfusion processes (Hybridoma, CHO, HEK 293, PerC6).
• Provided scientific and technical lead and troubleshooting during development phase, scale-up, engineering runs and cGMP manufacturing at scale.
• Supervision of all cell culture activities associated with client projects; development and/or optimization of processes including documentation, methods and reports.
• Process characterization.
• Lead scientist for upstream of four active client projects: Three cGMP processes at different stages of manufacturing and a fourth project at process development in the close-out phase. All activities completed in a timely manner and to the full satisfaction of the customer.
• Ownership of a project already running in the production suites within 24 hours.

Biotechnology Research Institute (BRI), Montreal, Canada, Research and Development, 1996 - 2001

• Research Associate int the largest biotechnology research and development center in Canada.
• Focus on bioprocess development and optimization of insect cell cultures.
• Led optimization of a fed-batch process by using Metabolic Flux Analysis (MFA) as tool with two specific host cell systems.

Postdoctoral fellow

• Process development and optimization of insect cell cultures.
• Focused on-line monitoring (O2-consumption, CO2-production, optical density, viable bio-volume) of bioreactor processes and its application to control and estimate the progress of infection and recombinant protein production.
• Development of an optimized fed-batch process for the production of a recombinant protein at high cell densities while maintaining cell specific productivity.

Honors & Publications

Credentials

• Root Cause Analysis

Languages

• English
• French (both written and spoken)
• German (native)

Education

• Ph.D. Biotechnology, Technical University of Graz, Austria
• MSc. Chemistry (Diplom Ingenieur), Technical University Graz, Austria