Expert Profile
8+ years of experience with two different ***** logics CMOs for cGMP production of MAbs, recombinant proteins, vaccines, ***** similars.
13 years of experience in process development/optimization with mammalian, insect, bacterial and yeast cultures
15+ years of experience with ***** reactors (SS and disposable) for batch, fed-batch and perfusion processes
*****-***** ***** ***** (February 2010 to present)
Associate director
*****-***** ***** ***** (BPAI) is a *****logics drug development ‘think tank’ providing consultative direction and support in the management of complex *****logics programs from concept, through to development and ultimately successful delivery of product for Phase I-III human clinical trials.
BPAI's mission is to assist innovator companies in the management of critical third-party service relationships through our extensive CMO experience plus our wealth of technical expertise in technology transfer, project management, process development and optimization, analytical development, scale-up and engineering manufacturing, cGMP manufacturing, compliance and regulatory support utilizing microbial, yeast and mammalian expression platforms.
QSV *****logics, Edmonton, AB, Canada (2006 to 2009)
Senior Scientist
QSV is a globally active contract cGMP *****logics manufacturer providing mammalian cell culture, microbial fermentation and purification services for the production of protein therapeutics.
I was lead Scientist in many projects that covered the entire spectrum from microbial to mammalian processes (E.coli, Pichia pastoris, Insect cells, Hybridoma and CHO).
DSM *****logics, Montreal, Qc, Canada (2001 to 2006)
Senior Scientist
DSMB is a multi-national contract cGMP manufacturing organization specializing in the production of *****pharmaceuticals.
I was lead Scientist in a wide variety of mammalian cell culture processes (CHO, Hybridoma, Per.C6 – batch, fedbatch and perfusion).
Practical experience – Technical Skills Summary
- Up-stream and Mid-stream process development (microbial and mammalian), optimization and implementation; batch, fed-batch and perfusion processes; fermentation development
- cGMP production of recombinant proteins and monoclonal antibodies with cell cultures at large scale
- cGMP production of *****pharmaceuticals with microbial cultures at large scale
- cGMP Production of recombinant proteins and virae (Insect cells / baculovirus) at high-cell densities
- Design of experiments; adherent and suspension cultures; cell based assays
- *****reactors: stirred tank, airlift, multi vessel systems, disposable technology (e.g. Wave-bag, SUBs)
- various cell retention devices for perfusion processes (internal spin filter, ATF, acoustic filter, settler)
- Mid-stream technology: homogenization, filtration (TFF and dead-end), continuous centrifugation
- management of unplanned changes: investigation, control, implementation
- validation (equipment and process) and change control
- On-line monitoring: capacitance (viable cell density), OUR, CER and traditional methods
- Hands-on experience with bacteria, yeast, fungi and higher cells from cryo-vial to *****reactor
- True Colors Workshop for Managers (2008)
- Oral Presentations with Impact (CFC Consulting group; April – June 2004)
- Root Cause Analysis (Rijnconsult; July 2002; Director: Mr. Terry Finlow-Bates)
- Management training sessions (Development Dimensions International, 2002 to 2003)
1996 Ph.D. in *****technology (Dr. techn.)
Departments of *****technology and Organic Chemistry, Technical University Graz, Austria
1994 Masters of Technical Chemistry (Diplom Ingenieur)
Department of *****technology, Technical University Graz, Austria