Kenneth De Avila Email & Phone Number

Jersey City, NJ, US

Newark, New Jersey, US

• Cultivate and manage relationships with key clients, including pre-clinical stage companies, phase I/II companies, and research institutions.
• Coordinate and execute promotional events, including webinars and conferences.
• Conduct market research, market forecasting, and competitor analysis to identify emerging trends and opportunities in the cell & gene therapy sector.
• Identify and pursue strategic partnerships and alliances with leading biotech firms and academic institutions. Negotiate and close agreements that contribute to increased revenue streams.

Newark, New Jersey, US

• Drove multiple technology transfers of cell therapies into CDMO manufacturing facility as client facing technical SME.
• Led a critical deviation investigation that yielded effective solutions to manufacturing process of key client during a phase 1 clinical trial.
• Created several risk assessments and key documents for client companies to expedite tech transfer, create a robust GMP manufacturing process, and ensure product quality.

Basel, CH

• Upstream SME for Technology Transfer (TT) of commercial CHO platform process from sister site in UK.
• Improving process performance through authorship, ownership, and driving implementation of key process change controls after completion of first Good Manufacturing Practice (GMP) batches at the Portsmouth site to.
• Support customer audit after completion of GMP batches in advance of PPQ. Provide detailed presentations covering process performance, lessons learned from first at-scale runs, and change controls/CAPAs.
• Partake in Failure Mode & Effects Analysis (FMEA) Risk Assessment (RA) to define further process improvements prior to PPQ.

Basel, CH

• Representing Manufacturing Science and Technology (MSAT) on project teams as an upstream technical subject matter expert (SME) and interfacing with customer technical and quality representatives
• Developing understanding and expertise of incoming customer processes undergoing technology transfer into facility
• Authoring/reviewing/and owning process related documentation (ex. process description, electronic batch records (eBR), facility fit/gap assessment).
• Authoring/reviewing change controls (including managing the implementation of the change as the assigned change agent)
• Monitoring and reporting on process performance (performing manufacturing data analysis and delivery of data in the form of live presentations to the client).

Basel, Baselstadt, CH

• As a member of the upstream bioreactor team and cell expansion team, I was responsible for organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site.
• Worked on the manufacturing floor to produce product, troubleshoot equipment, and provide ownership for specific pieces of processing equipment. -Performed adherent cell culture passages to allow proper growth and.
• Ensured the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promoted a culture of quality and compliance while driving a sense of continuous improvement.
• Assisted Technical Operations with resolving production issues via change controls, CAPA’s, and deviation investigations.
• Drove process improvements via revisions of Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).

Tarrytown, New York, US

• Developed fed-batch bioreactor strategies to improve CHO cell antibody production and product quality as part of late stage process development for specific cell lines.
• Researched, designed, maintained, and analyzed small-scale and benchtop bioreactor fed-batch experiments, including use of statistical Design of Experiments and JMP software.
• Independently operated, maintained, and performed troubleshooting on cell density counters and nutrient/metabolite analyzers (i.e. Nova FLEX, Nova CDVs, Advanced Inst. Osmometer).
• Extensive use of microbiology lab techniques including: aseptic technique in laminar flow hood; inoculation, sampling and feeding suspended cell culture in shake flasks and bioreactors; media and feed preparation.

Bethlehem, PA, US

• Observe the mechanical interactions between the Hantavirus and integrin protein receptor in CHO-K1 cells to discover the method of entrance into the host cell through atomic force microscopy.
• Prepare cantilevers with integrin receptor proteins to allow for use in the atomic force microscope. Culture dishes of CHO-K1 cells and prepare surfaces of the cells to use in the microscope.
• Assisting bioengineering PhD candidates to propose a model for internalization of the Hantavirus into the host cell.