Syed I. S.

About Syed I. S.

Experienced Quality Control leader with expertise in microbiology, molecular biology, data science, and QC/QA. Skilled in driving digital transformation, implementing AI-powered solutions, and enhancing lab efficiency while ensuring cGMP, FDA, and EMA compliance. Proven success in leading QC operations for clinical and commercial drug programs.Expert in Global Laboratory Digitalization, AI-driven predictive analytics, and intelligent monitoring systems to streamline workflows and boost data integrity. Strong background in cell and gene therapy QC, optimizing resources, and leveraging Lean Six Sigma to improve processes, reduce costs, and deliver results.Deep knowledge of ICH, 21 CFR regulations, with a focus on continuous improvement and audit readiness. Adept at leading cross-functional teams, strategic planning, and driving operational excellence through data-driven decision-making.Skilled problem-solver, strategic planner, data enthusiast, and project leader who understands the importance of communication, collaboration, and team-building. I leverage cross-functional teams\' mixed abilities to achieve optimal results and drive success for organizations in the life science industry.I am an action-focused and solutions-oriented leader who:⇨ Action-focused and solutions-oriented leader who drives organizations to substantially higher levels of performance.⇨ Forward-looking strategic, operational, and financial leader with experience in building flexible, multidisciplinary organizations capable of adapting to various business environments and technologies.⇨ Adheres to statutes, regulations, standards, and quality management systems while anticipating technical problems and creatively solving them.⇨ Builds a supportive, cohesive, and team-focused environment while maintaining a focus on the big picture and attention to detail.⇨ Aligns technical capabilities with business priorities to deliver quality results on time and in a highly ethical manner.Specialties: Quality Control | Strategic and Operational Planning and Execution | Operational Excellence | 5S | Kaizen | DMAIC | FDA/ICH Regulations | Quality Auditing | Budgeting | Staffing and Mentoring | Process Development/Systems Implementation | Contract Negotiation | Program/Project Management | Data analytics | Lab automation | Machine Learning & Advanced Analytics | Process Intelligence & Automation | Low-Code/No-Code Solutions | Trackwise, Documentum (QDMS) and SAP Systems | Veeva | AI - Predictive analytics I look forward to meeting you!

Experience

1. Cyber Defense Operations Specialist

   United States Air Force

   Dec 2018 — Present · New York, NY, US

Education

• Montclair State University

  Master’s Degree, Molecular Biology

• London Metropolitan University

  Bachelor’s Degree, Microbiology

• Massachusetts Institute of Technology

  Certification, Big Data and Social Analytics

Skills

• Dna
• Cell Culture
• Bioinformatics
• Lifesciences
• Microsoft Office
• Laboratory Management
• Matlab
• Plasmid Isolation
• Assay Development
• Genomics
• Restriction Digestion
• Glp
• Dna Sequencing
• Media Preparation
• Life Sciences
• Pymol
• Spss
• Pcr
• Laboratory
• Blast
• Statistics
• Molecular Biology
• Data Analysis
• Research
• Western Blotting
• Cell Biology
• Aseptic Technique
• Bacterial Identification
• Imagej
• Microbiology
• Biotechnology
• Scientific Writing
• Agarose Gel Electrophoresis
• Project Management
• Microscopy
• Leadership