Aymane E. Email & Phone Number

San Diego, Ca.

Lead and motivate the bioprocess development team, promote cross-departmental collaboration, and ensure professional development and training of team members to drive the development and application of new technologies and improve existing bioprocesses to increase efficiency, product quality and sustainability.

San Diego, Ca.

Developed and optimized cell culture process for biosimilar antibodies. Provided strategic planning to the management team. Developed a high performing cell culture team.

San Diego, Ca.

Built cell culture process development team from one associate to the capacity of developing three biologics in parallel. Established cell culture process from clone selection to scale up for clinical material supply.

South San Francisco

Key leader in establishing a new Biotherapeutics Development Unit, including strategic planning, budgeting, designing (floor plan design, equipment lay-out, utility requirements), execution (procurement, installation and testing), and cross-functional coordination.Ensured all the equipment met the short term and long term needs and with full consideration for future capability improvement based upon in-depth research. Saved hundreds of thousands of dollars on the budget through vendor negotiation.Established a fully functional cell line development and cell culture lab, optimizing cell culture process in single use bioreactor (SUB) and aligning processes with Novartis TRD-Biologics in Basel, Switzerland.Provided technical advice across projects and represented upstream on CMC team.

Foster City

Led cell culture development projects, process optimization, technology implementation, technology/process transfer and supported manufacturing, including cGMP cell banking, investigation, data analysis. and representation on CMC teams.• Developed perfusion-based high density cell banking technology. Accomplished implementation of the high density cell bank in manufacturing therapeutic proteins from CHO cells. This technology significantly increases the manufacturing throughput and saves several million dollars per campaign. Recognized in Pharmaceutical Operations & Technology 2009 Q1 report.• Overcame technical challenges and improved seed train culture expansion for a commercial program • Contributed to CHO platform technology development, cycle 1 project process development and fed batch optimization.• Managed cycle II project pre-development activities• Coordinated with cross-functional team members to support phase III re-supply campaign: identified issues, evaluated process adjustment for new facility fit and developed solutions• Evaluated new technology in enhancing recombinant protein production through collaboration with external innovators• Authored process development reports, PFD and GMP documents. Reviewed and approved batch records• Engage, inspire and develop direct reports

Thousand Oaks

• Managed and completed many projects from the initial literature searches to the final report generation. Generated master cell bank candidate for a protein therapeutic production with 2-fold improvements in productivity using molecular chaperones. Achieved the goal one month ahead of the projected timeline. Advanced the product to clinical development and earned the Bayer Scientific Achievement Award.• Effectively collaborated with protein analytical, purification and fermentation departments. Developed high producing cell lines for fed batch fermentation process within one year. Evaluated clones in small scale to 200-L bioreactor in a timely manner and provided recommendations for final clone selection. Delivered reproducible data for process transfer.• Improved process efficiency. Established one-step scale-up process for the inoculation of 200-L bioreactor. Shortened the standard process of 4-6 weeks to 3 weeks from thawing a vial to inoculation. Simplified the process and reduced workload 50%. • Applied versatile expression system and produced gram-scale human monoclonal antibodies in mammalian cells in less than two months. Purified 2.8 gram antibody from 300-L bioreactor harvest. • Utilizing highly effective planning successfully performed a genetic stability characterization study under a tight timeline to support the license application for a 200-liter bioreactor production of Kogenate (rFVIII).• Supported Kogenate re-engineering activities: new cell bank evaluation and down-regulation of a host cell protein in a candidate clone by anti-sense RNA.• Studied the roles of disulfide bonds in folding, secretion and expression of a recombinant protein in mammalian cells by site-directed mutagenesis.

M.D., Medicine

M.S., Medicine