LEADERSHIP OPPORTUNITY -- BIOPHARMACEUTICAL DEVELOPMENT OR MANUFACTURING -- Applying a unique breadth of experience and continuous improvement to develop and transfer scalable, controllable processes -- Differentiators A. I've been passionate about continuous improvement and waste elimination throughout my career • Multivariate data analysis (DoE) since 1992 • Risk mitigation tools since 1993 – HAZOP, what if • Six Sigma tools since 2001 – SPC, FMEA, DPM • Six Sigma Green Belt • Lean training (in progress) B. I offer a unique breadth of downstream experience: • lab-scale late phase development and optimization of chromatography and UF steps • Scale-up into Phase III drug substance production • Technical transfer to GMP pilot plant and commercial facility • Recombinant proteins from yeast and mammalian cell culture • Various protein classes – vaccines, mAbs, Fc-fusions, PEG conjugates History of Success Combining these abilities and experience, organization skills and attention to detail, I have orchestrated the following results: • 100% on time or ahead of time delivery and release of preclinical and clinical drug substance and drug product. • Prevented the imminent failure of at least three downstream scale-up projects prior to transfer into the GMP pilot plant based on risk assessment • Timely execution of scale-up studies to ensure successful transfer to commercial operations • Greater than 30% reduction in preparation time for campaigns • 96% reduction in process upsets and 100% reduction in cleaning failures in clinical production campaigns • 50% increase in step yield of a primary chromatography step and a 20% increase in step yield of an adjacent step based on identifying a process interaction Value proposition Put my abilities to work to increase your technical transfer or production campaign success rate, improve workflow, and eliminate waste.

Associate Director Downstream Manufacturing @ Leading a team of Senior Manufacturing Specialists and Technicians in the scale-up and clinical manufacturing of live virus vaccines, gene therapy products, and therapeutic proteins for client companies. Coaching, counseling, and guiding to ensure the best conditions for a successful team. Performing technical support and resolving events during engineering runs and conducting final fill operations. From December 2014 to Present (1 year 1 month) Associate Director of Downstream Manufacturing @ Leading a team of Specialists and Technicians in the downstream purification of vaccines and therapeutic proteins. In December 2014, FujiFilm Diosynth Biotechnologies purchased Kalon Biotherapeutics LLC. From September 2014 to December 2014 (4 months) Operations Engineer (salary grade equivalent to manager) @ Technical support of mammalian and bacterial-based, biologics processes - Upstream/Downstream through Packaging. Capital project work & Process validation From July 2012 to September 2014 (2 years 3 months) Athens, Georgia AreaIndependent @ From 2010 to 2012 (2 years) Research Scientist @ Same responsibilities as the Associate Manager position but with no direct reports. From January 2009 to January 2010 (1 year 1 month) Supervisor/Senior Supervisor/Associate Manager @ Group Missions: 1). Pre-clinical Production and Scale-up (Purification, Formulation, and Fill/Finish) 2). Prepare GMP bulk drug substance for Tox and Research Reference filling 3). Oversee fill/finish operation and facilitate GLP release 4). Conduct large scale ‘co-development’ runs to support Phase III optimization 5). Scale-up, co-develop, and co-transfer Phase I – III purification processes to cGMP pilot plant From 2003 to January 2009 (6 years) Engineer IV/Supervisor @ Group Mission: Late-stage process development into full-scale, cGMP production of a live, attenuated virus vaccine • Led a team of two supervisors and twelve technicians in the full-scale production of an attenuated, trivalent, viral vaccine using continuous-flow ultracentrifugation. From January 2001 to July 2003 (2 years 7 months) Contract Engineer/Staff Engineer @ Group Missions: 1). Phase III process development into full-scale, cGMP production of a recombinant vaccine particle 2). Technical transfer of processes to commercial facility From 1994 to 1998 (4 years) Co-op Engineer/Engineer/Engineer I @ Chemical process development at Fluorochemicals Pilot Plant. • Developed and supervised the operation of a product purification pilot plant. • Supervised the operation and optimization of distillation operations in a process flowsheet consisting of five recycle streams. • Managed the adoption of a novel set of in-process analytical methods. Tasks included: o Supervision of technicians in an organized labor environment o Initiation of a performance management system to track technicians’ progress with new analytical techniques. Averaged 35% improvement for each shift. • Led a safety committee to address various process safety issues. From 1989 to 1994 (5 years)

Short Course Certificate, Fermentation Technology @ Massachusetts Institute of Technology From 2014 to 2014 Lean Sigma training, Lean Sigma @ Villanova University From 2012 to 2012 Biochemical Engineering @ Drexel University From 2001 to 2004 BS, Chemical Engineering @ University of Massachusetts, Amherst From 1986 to 1990 BRRHS Chris DeMello is skilled in: Downstream Processing, Scale-up, Process Development, Career Development, Team Leadership, Technical Leadership, Six Sigma, Continuous Improvement, Covey Seven Habits, Emotional Intelligence, Column Chromatography, Ultrafiltration, Technical Transfer, FMEA, Facilitative leadership