Work experience

Cytiva (a part of Danaher)

Senior Engineer, Process development

• Defined and managed project scopes to enhance the lifecycle of new and existing products. 

• Planned and led Lean-based Continuous Improvement projects, achieving significant time savings in fill-finish operations. 

• Mentored junior staff, fostering a culture of knowledge sharing and team development.

Engineer I, cGMP

• Managed clinical production batches in a controlled environment, ensuring compliance with GMP standards.

• Engaged with customers and clients to understand their manufacturing needs and provided technical support for formulation process development from pre-clinical to clinical stages.

• Involved in the commissioning of cleanroom activities for a new facility, ensuring compliance and operational readiness.

• Led the development of biopharmaceutical manufacturing operations in a controlled cGMP environment. 

• Actively participated in Kaizen events, working towards Certified Practitioner certification for Standard Work implementation. 

• Provided guidance to team members, fostering collaboration to achieve team goals.

• Consulted with vendors to procure cleaning agents and raw materials necessary for GMP production of LNPs.

• Handled deviations and CAPAs for cleanroom batches to maintain quality and compliance.

• Developed and implemented operational procedures and SOPs for biopharmaceutical manufacturing in a controlled GMP environment.

• Actively participated in Kaizen events with internal and external stakeholders to enhance the efficiency of the drug development process.

• Collaborated with preclinical, process development, QC, QA, project management, and product management teams within the Biopharma services team to align with team goals.

Process Development Engineer, Preclinical services

• Developed processes for LNPs, scaling from small batches (0.3 mg RNA) to clinical production (6 g RNA), with formulation bulk product volumes up to 50 L post-mixing.

• Prepared large batches of lipid mix and buffer solutions, ranging from 15 to 30 L.

• Handled cytotoxic and BSL-2 level materials safely and effectively.

• Successfully executed client-led engineering and GLP-tox batch runs.

• Acquired a solid understanding of PSP, Kaizen, and Lean Six Sigma principles.

Research Associate, Preclinical services

• Formulated lipid nanoparticles and polymeric nanoparticles for nucleic acid delivery using PNI NanoAssemblr.

• Conducted thorough literature research to develop formulations with NanoAssemblr microfluidic devices based on client needs.

• Served as the primary contact with clients to assess business needs and coordinated with internal research teams to ensure delivery according to specifications.

• Conducted extensive research on lyophilization process conditions and their effects on LNP size and encapsulation efficiency (%EE) of payloads.

• Designed experiments using DOE principles and Design Expert to optimize the primary drying step in lyophilization for lipid nanoparticles.

• Developed and optimized lyophilization processes for LNPs using advanced process optimization techniques.

• Optimized tangential flow filtration parameters to reduce operating time while minimizing shear rate and increasing flux rate.

• Transferred processes from small-scale proof-of-concept studies to large-scale formulations for clinical manufacturing.

• Focused on the process development and scale-up of LNP formulations from small scale to clinical manufacturing.

• Managed multiple projects with tight deadlines, ensuring timely delivery.

• Collaborated with engineering, manufacturing, and scientific teams to achieve excellence in drug discovery and development.

• Performed formulation characterization and in vitro assays to determine size, zeta potential, and biological properties.

• Designed prototypes for lab equipment and materials using 3D SolidWorks and FDM 3D printing.

• Worked collaboratively to implement study plans, conduct technical discussions, and achieve project goals.

• Prepared Standard Operating Procedures (SOPs), batch cGMP reports, and technical presentations.