Kamrul Hasan

• Providing technical support for routine manufacturing operation, process improvements, lifecycle management of 3 commercial drugs.
• Driving External manufacturing excellence and technology transfer as shown in scale up and technology transfer of 1 technology from one site to another.
• Providing technical guidance in collaboration with SMEs, identified multiple root causes of deviations and OOS events as evidenced in providing CAPA that solved 1 buffer issue completely and reduced (60%) drug substance hold time deviation.
• Engaging internal and external stakeholders for change management, issue resolution and completed 7 change control management for replacement of methods, specification updates, and stability protocols updates.

· Led a matrix team of analytical scientists and improved a 1 cell culture product by reducing the manufacturing drying time from about 120 to 5 h and reduced alcohol consumption to 60%.

· Provided technical guidance in collaboration with SMEs to support root cause analysis and product impact assessments as demonstrated in providing 1 CAPA to solve product packaging and labeling issue.

· Collaborated with cross-functional teams including analytical development, process development, quality assurance, regulatory affairs as evidenced in qualifying 2 contract testing sites.

· Drove method qualification, validation, and transferred 1 method from one site 3 sites to improve raw material characterization.

· Performed a list of analytical tests in GLP environment to establish/support the drug product's shelf life and Improved 1 drug dissolution method of small molecule drug product.

· Authored/reviewed reports as sourced documents for inclusion in regulatory filings as demonstrated in reviewing analytical reports to support a filing in new markets.

· Performed analytical tests for a variety of products including solid oral dosage forms and recognized as a qualified reviewer to review peers reports.

· Set up a laboratory and led a team a to develop 1 prototype biosensor for food safety diagnostics.

· Collaborated with 4 external analytical laboratories in biologic analytics, wrote 1 protocol and multiple grant applications, and received $0.5M as investor funding.

· Led a team in critical analysis of laboratory operations, equipment and techniques and developed 1 biosensor.

· Developed analytical methods for large molecules and lead a group of scientists on multiple projects as demonstrated in 9 scientific publications.