Ajit Smith-Iyer Email & Phone Number

South San Francisco, California, United States

Leverkusen, North Rhine-Westphalia, De

Leadership position within the global CMC organization. Manage a team of operations personnel, engineers and working with CMC, analytical and supply chain teams to deliver clinical material for early stage clinical trials for a wide range of therapeutic modalities – antibodies, autologous and allogenic cell therapies Work with CMC development, process technology , supply chain and quality on implementation of single use technologies for end to end manufacture of biological products for early stage clinical manufacturing. This process will be a platform process that will be transferred to commercial/launch facility in later stages of clinical development.Manage portfolio of projects to reduce cost and improve efficiency during clinical manufacturing and technology transfer. Ensure that clinical manufacturing facility and process meet GMP and regulatory requirements and lead team during audits from external agencies including FDA/EMA. Support clinical teams for filing regulatory submission in support of early stage clinical trials. A member of Bayer Biopartnering solutions team , working the external companies on collaborations and partnership for bioprocess development and clinical manufacturing .

Leverkusen, North Rhine-Westphalia, De

Managed a team (30+ engineers & IT specialists) responsible for implementation of digital strategy on site Developed digital strategy in collaboration with global colleagues for realization of pharma 4.0 on site Managed the portfolio of technology projects (>$10 Mio in 5yrs) to reduce cost and time of product transfer from early stage clinical manufacturing to late stage clinical/commercialization. Participant in plug and play technology at Biophorum – testing plug play concept for cell therapy platform for future implementation Supported design, conceptual design, implementation and validation of process/utility and manufacturing IT systems for two new clinical and launch facilities (>$100 Mi investments) supporting cell therapy and antibody/traditional modalities.Active leadership role between Bayer site in Berkeley and the community including ◦ Advisory board member for Lawrence Hall of Science ◦ Active participant in the development agreement process including speaking at public forums on behalf of Bayer. ◦ Bayer member for West berkeley resiliency fund committee (as part of development agreement) – responsible for managing the distribution of allocated funds including strategic direction for the funding.

Leverkusen, North Rhine-Westphalia, De

Led a team of 10+ upstream, downstream and cleaning validation process responsible for process engineering ad process technology development in support of commercial products (kogenate, kovaltry and jivi). Process engineering team was responsible for process engineering deliverables (concept, detailed design thru process validation) for introduction and launch of new product jivi from clinical. The team developed and implemented technology improvement in API drug substance and Drug product facilities to reduce cost of manufacturing and reducing cycle times. - BIOG model a scheduling/capacity model for API and filling and freezing for rfVIII production - increase number of lots from 3 lots to 4.5 lots per week which was needed to meet incresing market demand.

Leverkusen, North Rhine-Westphalia, De

Upstream cell culture SME responsible for development and introduction of novel upstream technologies and process improvements in commercial manufacturing of biological products (Kogenate a recombinant rFVIII product).Responsible for managing process improvement program with budget of 1-2 Million annually including business case, technology assessment and testing, implementation including change management and validation and regulatory submissionsCommunication to senior management - cost, timelines and risk mitigation strategies. Implemented single use technologies in commercial production to reduce cycle time , including dual sourcing for critical single use components.

Gaithersburg, Maryland, Us

• Developed a new high titer MDCK cell line in a new serum free media (patented) that was able to produce all three annual strains of influenza at titer comparable or higher than in eggs and helped maintain the original characteristics of MDCK cells • Co author on $100 Million grant from the HHS that supported the development of a novel a cell culture process for manufacturing live attenuated influenza vaccines in MDCK cells to replace commercial egg based process (Flu Mist) . • Developed a scalable bioreactor process using microcarrier beads for large scale production of Flumist live attenutated vaccine - 1L lab scale thru 500L to 10,000L bioreactors. • Technology transfer lead of PIV/RSV cell culture based vaccine from development to clinical facility including successful manufacturing of phase I/II IND enabling lotsDesigned and executed lab scale experiences to characterize upstream processes to identify Critical process parameters and in conjunction with downstream and analytical development team critical quality attributes in preparation for phase II and phase iii clinical trials.

Hayward, Ca, Us

• Process development Upstream and subject matter expert in CMC team for multiple phase I/II clinical programs including autologous cell therapy (GVAX) program, AAV program for FIX and FVIII haemophilia, and oncolytic virus program. • Developed upstream cell culture process for adherent and suspension processes for production of adenovirus and AAV viral vector for clinical trial using transient transfection as well as producer cell lines obtained from research. . • Successfully transferred process to remote clinical manufacturing plant in San Diego CA in support of clinical program for AAV gene therapy and autologous cell therapy GVAX program. • Was part of CMC subteam including quality , qc and regulatory that worked on IND filings for these clinical programs. • Support due diligence activities for M&A opportunities. • Member of American Society for Gene Therapy – part of team that developed first adenovirus reference standard material (RSM) – viral titer, vector genome titer and infectious titer.

Doctor Of Philosophy - Phd, Chemical Engineering

Master Of Science - Ms, Chemical Engineering

Bachelor Of Technology - Btech, Chemical Engineering