Process design for the commercial manufacture of biological products including project feasibility, cost of goods, equipment requirements, project and process scheduling/timelines, validation requirements.

Team member working closely with other department leaders (Manufacturing Sciences and Technology (MSAT), Engineering, Facilities, Maintenance, Quality Assurance and Drug Development leads) to design and build a world class biotech commercial manufacturing facility. Highly involved SME and leader in the design of USP equipment/single use process requirements for a greenfield facility with associated technical/design/compliance decisions. Providing concise updates and status on progress, escalation of critical/relevant concerns to the Head of USP, senior management. Selection/assessment of technologies, equipment, materials and procedures suitable for various biologics processes (monoclonal antibodies, mRNA, vaccines, non-antibody proteins) for USP process transfer, scale-up and manufacturing including resources, support and control systems. Defining facility operational outcomes/manufacturing projections supporting global supply chain including drug distribution. Ensuring adherence to CGMP, biologics USP for clinical and commercial products.Key Responsibilities• Participate in project discussions and interact with vendors, contractors, engineering consultants and local authority for seamless design implementation.• Generate, review, and finalize technical documents for internal/external stakeholders including vendors and regulatory bodies.• Participate in project timelines, budget, and stakeholder meetings for effective integration of technical and business administration aligned with corporate expectations and organizational objectives• Ensure CGMP compliance of all processes and equipment. Identify and resolve technical, procedural & equipment or material issues to ensure that all meet industry best practices and compliance• SME supporting the design of relevant USP Manufacturing Operations including but not limited to URS preparation, FAT/SAT review, IQ/OQ/PQ, Engineering Runs• Participate in audits, regulatory inspections, CAPA implementation

Multifunctional team member for Resin Manufacturing Facility design including equipment design/selection and fabrication coordination, shipping container lab design (electrical utilities, flooring etc), source and build, admin (RFC, project plan) personnel hiring (posting, interviews, candidate selection). Expanded Bed Adsorption (EBA) Resin Manufacturing - process/equipment design and scaling, SOP preparation and review, BOM, process cost estimates, definition of manufacturing schedule/capacity, operator training (pre-departure training, overseas program definition, module development) travel coordination. Commercial column build (RFP, fabricator selection, project staging), Column/distributor design and fabrication, coordination and reporting, column testing, oversee novel column design, build and motor modification, programming. Support for implementation of eQMS.

Development and implementation of process and product improvements in industrial manufacturing of bacterial (diphtheria, pertussis, tetanus) and viral (polio) products. Gap and root cause analysis, process/product analysis, troubleshooting, OOS/OOT investigations. Improvement of equipment, assays, procedures, and process design. Subject matter expert in bacterial and viral processes at manufacturing scale. Focus on yield improvement, implementation and optimization of downstream processes and equipment, study design and execution, scale up and scale down studies, industrialization. Providing impact assessments, protocols, reports. Coordination and reporting of cross-functional projects with Compliance, Regulatory, Quality, Production, Engineering departments. Budget management.- Implementation of integrated chromatography unit for at scale polio purification; URS, equipment sourcing, automation, validation, continuing support and training.- Pertussis manufacturing process SME; double digit percent yield increase - Maximizing product robustness and quality in improvements to purification matrix to increase impurity removal- Cost reduction through operational improvement of membrane regeneration- Multifaceted project management; maximizing polio manufacturing yields including bioreactor modifications, analytical technique alignment, and cell culture improvement.- Enhancement of downstream purification techniques to improve pertussis vaccine quality.- Subject matter expert participation at inspections and ongoing validations.- Providing updates to steering committee/operational committee/team- New employee training on manufacturing processes, manufacturing safety, roles and responsibilities.

Development of diagnostic assays for human vCJD, scrapie and alzheimer’s based on immunoassay technology. Level 3 laboratory training and experience. Optimization of detectability of recombinant and endogenous, plasma-derived antigens.