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. • Designed and built a 40,000 sqft GMP AAV manufacturing facility in China. • Effectively managed CDMOs to stay on track of the timeline, and successfully produced 8 GMP lots.

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.• Successfully transferred the manufacturing process from the internal lab to an CDMO, and from one CDMO to another CDMO.

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 study within a very aggressive timeline.• 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 lines expressing therapeutic proteins, including monoclonal antibodies and recombinant proteins), and communicated with the licensees about the project progress on a regular basis.

• 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