Amit Katiyar Email & Phone Number

United States

Alameda, California, Us

Cambridge, Massachusetts, Us

Enabled ADC process development and manufacturing for Magenta Therapeutics to support clinical investigation for two lead candidates. Led CMC strategies to support early and late-phase development and manufacturing. Led a team of scientists for executing process and analytical development activities, managed budget and annual operating plans (AOP), handled prioritizations, and provided proposals for go/no-go decisions. Provided leadership to multiple cross-functional teams comprised of different functional areas by utilizing effective leadership and project management. Worked closely with senior management to resolve resourcing and prioritization conflicts across functions to ensure efficient design and timely execution. Participated in regulatory submissions.

Led a team of 60+ people to support Patheon’s pipeline of early and late-stage programs focusing on CMC technical operations for analytical and formulation development including methods (bioassay, separations, impurities), protein characterization, new technology, and formulation development. Supported global manufacturing and GxP operations for cGMP lot manufacturing and qualification/validation of analytical methods at Patheon. Led network alignment on harmonization and standardization of analytical and formulation workflows. Served as a steering committee member for various programs to guide the successful execution of program strategy across different biologics units at ThermoFisher Scientific. Led and delivered signed work of scope to customers with a high degree of Right First Time and On Time Delivery and actively kept Net Promoter Scores (NPS) scores higher, expanded projects and scope of work with existing and new customers. Designed, recommended, and developed strategies to drive site/business growth. As an Interim Site-Head forecasted financial results and maintained departmental budgets, including monthly status reports. Drove process and analytical improvements and operational efficiency initiatives and led change throughout the department. Actively supported sales in bringing new programs, clients, and businesses to the site and supported discussions related to site capabilities and technologies.

Lawrence Township, Nj, Us

Led a large team responsible for developing and qualifying separation analytical methods for early and late-stage therapeutic proteins (mAbs, ADCs, and combination products). Engaged with the commercial analytical organization for supporting technology transfer and validation activities for commercial assets (Opdivo and Empliciti). Led platform method development activities to achieve fast-to-FIH timelines with well-defined methods. Interfaced with process development teams to address analytical methods and strategy for PD. Successfully contributed to defining the analytical strategies for a first combination product (Opdivo+Yervoy) at BMS with different ratios.Engaged in coaching, mentoring, and motivating team members to integrate individual development and group dynamics to establish a well-balanced team..

New York, Ny, Us

Led CMC teams (upstream, downstream, analytical, and manufacturing) to support the key deliverables for phase III/commercial supply. Managed cross-functional teams in developing comprehensive integrated development and supply plans for the commercial product. Prepared and managed timelines for process development, manufacturing, quality, regulatory strategies in readiness for BLA submission.Provided leadership in critical areas of protein therapeutics including demonstration of comparability, specification setting, defining strategies for formal stability study, analytical method qualification and validation strategies. Technology transfer to external contract manufacturing facilities, collaborated with external contract research facilities, implemented Quality by Design based manufacturing process development, process validation at the external manufacturing sites, and process robustness and efficiency improvements to support the commercial supply of DS and radiolabeled DP. Managed analytical and process development for I-131 labeled monoclonal antibody (Iomab B) for commercial manufacturing. Iomab B will be used to condition patients suffering from refractory and relapsed Acute Myeloid Leukemia (AML) over the age of 55 for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant.Supported key regulatory submissions (IND amendments, BLAs, briefing books) and authority interactions in F2F meetings, provide leadership in supporting key technical reports and documents required for regulatory submission.Provided leadership in resolving program and cross-functional challenges with internal and external teams demonstrating negotiation and resource management skills. Reported directly to the CEO and President of Actinium Pharmaceuticals.

Rahway, New Jersey, Us

Managed a team to support analytical and process development for phase III/commercial biologics. Interfaced across other biologics organizations (upstream, downstream, regulatory, quality, and manufacturing) to support BLA filing. Led isolation and characterization of impurity strategies for BLA submission for Keytruda. CQA team lead for biosimilar and novel biologics.

Kenilworth, New Jersey, Us

Designed and executed scientific research projects for purification development and manufacturing of biosimilars and novel biologics. Provided technical expertise on purification process development of clinical/commercial phase processes, and coordinated with external resources (CMOs and CROs) necessary to complement internal process development efforts. Collaborated with the analytical and upstream development teams to successfully resolve the issues faced during development.Developed biologics process for supporting phase III and commercial manufacturing. Technology transfer of purification process to manufacturing sites. Defined the scope of facility fit, control strategies, and supply chain for DS. Led storage logistics for DS containers to support a flexible but robust supply of DS throughout the product life cycle.

Ph.D., Chemical And Materials Engineering

M.Tech, Chemical Engineering

Bachelor Of Technology - Btech, Biochemical Engineering