Eight years of expertise in formulation and pre-formulation research on compounds of pharmaceutical interest
Expertise in bioavailability enhancement of poorly soluble compounds via various techniques (lyophilization, spray drying, nanotechnology, etc)
Expertise in nano-suspension development (long acting and fast solubilization)
Experience managing CRO/CMO
Strong laboratory skills and expertise; extensive hands-on analytical experience:PSD, HPLC, DSC, TGA, PXRD, DVS, NMR, IR, SEM, and Optical Microscopy
Proven ability providing elegant solutions to complex problems
Excellent interpersonal skills; respectful of diversity
Highly motivated; results oriented; team player
Senior Formulations Scientist @ Motivated senior formulation scientist to oversee the timely delivery of drug products to support the Company’s clinical studies.
Drives formulation development, optimization, and production using rational design and data analysis
Leads the validation strategy for the commercialization of drug product production
Executes technical transfers, scale up, and clinical manufacture at CMOs
Writes and reviews technical reports, including regulatory filing source documents
Preparation of IND and NDA CMC sections
Prepares and presents experimental conclusions at various technical meetings
Assists with clinical trial material packaging, labeling and distribution. From November 2015 to Present (2 months) Scientist 2 (Formulation) @ • Co-led a controlled release intra-articular injection project; changed leadership’s opinion and revived this terminated project
• Led nano IV formulation feasibility studies; enabled a strategic decision-making at company-scale
• Provided formulation support to significantly improve oral bioavailability of a BCS Class III compound
• Participated a lyo-formulation optimization project for a combo IV product From January 2013 to May 2015 (2 years 5 months) Greater Boston AreaScientist III @ • Led the life cycle management of ALKS 9070 program: long acting nano-suspension
• Led pharmaceutical evaluations of multiple new chemical entities
o Develop formulation strategy to provide the target release profiles
o Conduct API form-discovery, form-selection, and salt screening and support pre-clinical studies From March 2008 to December 2012 (4 years 10 months) Greater Boston AreaResearch Investigator @ • Led the development of polymer based anti-HIV/contraceptive combo products for vaginal use
• Conducted Carraguard® stability studies for phase III clinical trial
• Directly managed one employee; ensured he was fully competent and capable of outstanding performance. From January 2006 to February 2008 (2 years 2 months) Greater New York City Area
Doctor of Philosophy (Ph.D.), Organic Chemistry @ University of Oklahoma From 2000 to 2005 Bachelor’s Degree, General chemistry @ Nanjing University From 1994 to 1998 Richard Hu is skilled in: HPLC, Drug Discovery, Chromatography, UV/Vis, DMPK, DSC, Poorly soluble Compound, Solid State Characterization, Nano Suspension, Lyophilization, IR, PXRD, CRO, CMO, DVS