Robert Lu Email & Phone Number

• As the first employee of the company, helped the company close the Series B financing of $160M, and grow the company from 1 person to 130+ within 3 years.
• Filed five IND in 3 years.
• Part of the Sr. Leadership Team and make high level decisions on company strategy and operations.
• Built a 20+ scientist PD/AD teams and advanced 4 different AAV programs from drug candidate nomination to IND.
• Successfully developed manufacturing processes for 4 AAV products and transferred the processes to GMP manufacturing at either 200L or 500L scale.
• Designed and built a 16,000 sqft research lab in US.

Boston, Massachusetts, US

• As the 5th employee of the company, helped the company go public (IPO) within 2 years, and grew the company to 150+.
• Filed the first IND within 18 months and received the FDA clearance.
• Part of the CMC leadership team (PD, Manufacturing and QA) and make high level decisions on the CMC strategy and operations.
• Built a 35+ scientist PD/AD lab to develop the manufacturing process and analytical methods for product release.
• Effectively managed CDMOs to produce 20+ GMP batches.
• Developed an improved manufacturing process, performed compatibility study, and implemented it in the GMP manufacturing.

Paris, France, FR

• Optimize the cell culture process of a commercial biologic drug within the FDA filing ranges. The process has been successfully transferred to cGMP manufacturing and has yielded 25% productivity increase consistently.
• Developed and utilized small scale cell culture models in supporting cGMP manufacturing including process change, deviation investigation, exploring design space, and evaluating raw material change.
• Interfaced with other departments including Facilities, Process Validation, Manufacturing, and QA to develop detailed manufacturing plans to support engineering runs and PV runs.
• Provided scientific leadership in deviation investigation, process improvement, and risk assessment of raw material change and process change.
• Authorized change control documents, SOPs, and OJTs, and updated PCS (Process Control Strategy) and OCS (Operational Control Strategy).

• Created a fast and robust Phase I cell line generation platform implemented for the development of four antibody biosimilar projects.
• As the project leader, led a cross-functional project team to successfully advance the lead biosimilar project (Bevacizumab) from DNA construction to lead clone selection, process development, and preclinical PK/PD.
• Studied and screened ~50 technologies that enhanced mammalian cell expression, and evaluated the top ten technologies in PER.C6® expression system.
• Revamped the cell line generation platform that became the standard platform for all licensees using the PER.C6® cell line. Directly contributed to six contract projects for PER.C6® licensees (generating clonal cell.

• As member of the company’s research steering committee, conducted research in the lysosomal storage diseases and contributed to the evaluation of 10 enzyme replacement therapy targets.
• Worked at bench level to validate the selected targets including protein expression, purification and characterization.

Ph.D., Chemisty

Bs, Biology

Doctor Of Philosophy - Phd