Swetha Katakam

• Led cross-functional teams for successful project delivery within scope, schedule, and budget constraints; Primarily focused on product development in Clinical Phase 2; planning ahead for Phase 3 and licensure activities.
• Crafted and maintained project plans and schedules to meet organizational objectives.
• Nurtured strong working relationships with internal and external stakeholders, building trust and credibility that facilitated smooth collaboration on shared goals.
• Spearheaded process improvement initiatives that resulted in increased productivity and streamlined workflows across departments.
• Managing multi-million budgets on USG & BARDA funded contracts while effectively controlling costs through diligent financial oversight.
• Cultivated culture of innovation within project teams, encouraging exploration of new ideas and approaches to problem-solving.
• Adapted quickly to unexpected challenges or obstacles encountered during project execution, devising creative solutions without compromising objectives.
• Developed comprehensive project plans, identifying risks and mitigation strategies for timely completion.
• Evaluated vendor proposals, selecting those that provided the best value for cost, quality, and timeliness.
• Coordinated and Managed IND preparation effort with both clinical, Nonclinical, CMC and regulatory teams.

• Oversaw large portfolio of projects to support teams, report progress, and influence positive outcomes for key stakeholders.
• Leading Construction projects like Commercial Facility expansion and associated Scale up & Scale down tech transfers, and R&D product development.
• Leading cross functional leadership team for Commercial Product Launch. Developed Program & Portfolio Management Governance for Product Launch.
• Contingency planning, risk mitigation, and close monitoring of project deliverables to meet planned timelines effectively.
• Develop, Maintain and set project deliverable priorities, and cross project dependencies.
• Directed changes to project scope and cost and implemented appropriate change management processes to keep project on track.
• Monitored contracts and service level agreements to identify potential risks and implement mitigation actions to protect development process from unforeseen delays and costs.
• Maintained schedules to meet key milestones at every project phase
• Oversaw large portfolio of projects to support teams, report progress, and influence positive outcomes for key stakeholders
• Communicated project plans and progress to key stakeholders and project contributors
• Partnered with project team members to identify and quickly address problems
• Developed and maintained project budgets to control costs and meet organizational and project goals
• Coordinated cross-functional teams to determine timely delivery and compliance of project requirements
• Crafted and maintained project plans and schedules to meet organizational objectives
• Updated end client team and senior leaders on progress and roadblocks
• Presented Technical documentation to Executive leadership team, translating complex studies into universally comprehensible language
• Established and managed change management processes to fulfill successful project transitions
• Training teams through use of Problem solving (taproot, fishbone, 5Y, Cause-mapping, Contradiction-matrix), FMEA, risk assessments/management, Kaizen events - Deviation Management.

• Tech transfers (pre-clinical, clinical, late-phase and commercial; CMC) from diverse technologies across pharmaceutical industry including specialized formulations such as liposomal nano particles with modified messenger RNA, Monoclonal antibodies, large molecule sterile formulations, small molecule parental and oral solid dosage forms.
• Leading and managing projects in compliance with ICH guidelines, FDA. IMPD, IND, ANDA, MAA regulatory support, Audit support
• Coordinating and overseeing interdisciplinary team activities/ cross function team management.
• Contingency planning, risk mitigation, and close monitoring of project deliverables to meet planned timelines effectively.
• Creating Gantt Charts, resource management, project summary reports using Microsoft project.
• Managing and tracking project deliverables, CMC Technical support. SME/Product technical development/manufacturing process owner.
• Contract Scope and Budget Management across project.
• Primary liaison between company and client.
• Vendor management, Vendor qualification - CMO, 3rd party coordination Analytical testing labs, CROs
• Project kickoff meetings, weekly updates, meeting updates, official memos, agenda.
• Whiteboard meetings, problem solving (taproot, fishbone), FMEA, risk assessments/management, Kaizen events - Deviation Management, Change Control implementation, handling product complaints, continuous process improvement in commercial manufacturing.

• Developing, coordinating, planning, designing and executing project from kick-off to product launch. Managing/interacting with multiple teams from vendor management, supply chain, planning and tech operations to client communications. Multidisciplinary team management.
• SME – oxygen vial head space analysis, Tangential flow filtration (principles of ultrafiltration/diafiltration) (TFF skid from pall®). Coordinating and resourcing multiple disciplines - Product development, Manufacturing, Analytical development, supply chain management, subcontract management, Packaging, regulatory submissions and Stability in CDMO.
• FMEA, Deviation management, root-cause analysis (RCA trained), Risk assessment, Tap-root (trained), Process improvement, statistical analysis - Process capability Analysis, Control Charts, DOE
• Direct client interactions, site tours, part of GEMBA (part of Six Sigma implementation) walks.
• SME in Lipid Nano Particle (LNP) manufacturing science and drug product process development. New Condo model construction and tech transfer implementation
• SME for a completely automated Prefilled syringe line - Isolator technology . Been a process engineer/ technical lead/project activities coordinator with multiple disciples – EM, Production, Validation, and analytical AR&D.
• SME in Single Use Technology in Biopharmaceutical Manufacturing. Designing Process flow path from manufacturing to fill to inspection and release – Biosimilars, true solutions, lyophilized products, lipid nano-particles, protein purification.
• Involved in every stage of Tech transfer, drug development and supporting all activities from developing process, development summary reports to clinical batches, product filing to process validation batches.
• Technical Documentation, lead team of manufacturing associates to direct tech transfer technical product pathway, ensuring FDA and GMP compliance.
• Technical expertise in - Sterile liquids, Lyophilized vials, pre-filled syringes, and Lipid-Nano Particles. Specialized in designing Single-Use Bio-process materials in product manufacturing pathway from fill to finish. Very creative approach in designing new product delivery pathway.
• Technical writing - SOPs, Batch records, Development protocols, summary reports, and Regulatory documents.
• Managing team; to drive activities to completion.
• Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
• Used strong analytical and problem-solving skills to develop effective solutions for challenging situations
• Demonstrated respect, friendliness and willingness to help wherever needed
• Self-motivated, with a strong sense of personal responsibility
• Proven ability to learn quickly and adapt to new situations

• Analytical Development and tech transfer projects.
• Technical writing - Lab Investigations, SOPs, CAPAs, PAs and Tech transfer summary reports

• Finished Product Testing on Continuous Process Validation, Product Process Improvement validation, routine validation batches.
  
• Cleaning Validation, Analytical Tech Transfer projects

• Research Assistant for project - Simultaneous Analysis of Fat Soluble vitamins using UHPLC-UV/Mass Spec.
• Research Assistant for project - Interaction of Insulin with Soy.
• Attended seminars and symposiums to improve overall knowledge and understanding
• Worked both independently and collaboratively in fast-paced laboratory environment

Quality Control monitoring on manufactured bulk drugs.

• Completed Project on Vaccine Manufacturing plant Environmental monitoring - Process Improvement Strategy
• Demonstrated creativity and resourcefulness through development of innovative solutions