Lead high-value client projects ranging from $1M–$3M, overseeing biopharmaceutical process development from small-scale feasibility studies through process scale-up and large-scale batch manufacturing.
Integrate scale-up feasibility, equipment capabilities, and process constraints into early-stage development strategies to ensure manufacturability and minimize downstream technical risks.
Drive cross-functional project planning through Danaher’s Value Process Management (VPM) frameworks, coordinating with multiple Danaher operating companies to align deliverables, manage dependencies, track milestones, and ensure timely execution.
Lead technology transfer to external Contract Development and Manufacturing Organizations (CDMOs), facilitating successful process implementation and GMP batch manufacturing.
Conduct risk-based gap assessments and coordinate material, consumable, supplier, vendor, and process readiness to enable seamless technology transfer and manufacturing execution.
Coordinate team resources and experimental schedules, balancing project priorities, associate availability, and laboratory capacity to deliver development milestones efficiently.
Manage client communications through a transparent, collaborative approach, proactively addressing technical challenges, communicating process changes, and aligning stakeholders on mitigation strategies and project deliverables.
Establish and refine drug product specifications based on critical quality attribute (CQA) trends observed during development batches, translating process development insights into alignment with internal Quality Control (QC) teams and client requirements for Investigational New Drug (IND) submission activities.
Define and manage project scopes, deliverables, and development strategies to support the lifecycle management and continued development of new and existing products.
Lead Lean-based continuous improvement initiatives, delivering significant reductions in fill-finish operational timelines and improving process efficiency.
Mentor junior engineers and associates, promoting technical knowledge sharing, experimental rigor, and effective team collaboration.
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.
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.
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.