William Lu

847-***-****

ac4l8w@r.postjobfree.com

PROFESSIONAL SUMMARY

Associate Scientist (Formulation Drug Product Development)

Formulation Scientist with over 15 years of experience in the Pharmaceutical, Biologics, Protein, small molecule industry spanning from quality control to early and late stage product development. Strong background in sterile injectable compounding, pilot plant operations, technology transfer and scale-up, biologics, design of experiments, statistical analysis, continuous processing utilizing nab (TM) technology platform, lyophilization cycle development, early and late stage risk assessments, quality control, quality systems, and Moist Heat Sterilization. Experts in Nano-suspension physical stability monitoring - microscopy examination and static/dynamic laser-light diffraction measurements and stability testing.

TECHNICAL EXPERIENCE

Liquid formulations combine the drug product with a variety of compounds to ensure a stable active medication following storage - include solubilizers, stabilizers, buffers, tonicity modifiers, bulking agents, viscosity enhancers/reducers, surfactants, chelating agents, and adjuvants. Actively engaged in the evaluation technologies, as membrane purification, and scale-up of chromatographic purifications.

Excipient compatibility studies to select viable excipients that are chemically and physically compatible with the API(s).

Process feasibility study is conducted to determine the manufacturing process or technology enables the formulation to achieve the target.

Formulation preliminary study to select the final excipients.

Formulation optimization study to define the optimal levels of all excipients in the formulation and scale-up.

Manufacturing processes of a pharmaceutical product are optimized by a systematic approach, the scale-up and processes validation efficient robustness of the formulation.

ACCOMPLISHMENT

CELGENE CORPORATION Jan 2011 - 2017

Associate Scientist Drug Substance Development (Member of Formulation Drug Product Development)

Manage with direct reports and independently lead, plan, and execute pre-formulation and formulation & process development activities in support of biologics and small molecule candidates.

Design DOEs, formulation screening studies, stability studies, and biophysical characterization for early and late stage molecules.

Manage and Origination Formulation Laboratory Activates: Prepare raw material, prepare and execution compounding batches, in-process and finished product samples for stability testing and analysis.

Pilot scale batch record design, simple and complex batch processing, sterile filtration, filling and lyophilization.

Develop small scale studies to give feasible solutions to large scale GMP process issues.

Work in cross-functional teams (Tech Services, Engineering, Analytical, QC, etc.) to successfully drive multiple client projects within set budget and timeline.

Learn and implement new technologies in a short span to execute client deliverables and expand the department capabilities.

Performed routine laboratory activities that included monthly cleaning, equipment calibration and maintenance, compliance supporting activities, and the ordering and stocking of supplies.

CELGENE CORPORATION (FORMERLYABRAXIS BIOSCIENCE) Jan 2008 - Jan 2011

Associate Scientist (Formulation Drug Product Development)

The world's first and only protein-based nanoparticle chemotherapeutic compound nabs (TM) technology (AbraxaneTM).

Manage and Origination Formulation Laboratory Activates: Prepare raw material, prepare and execution formulate batches, in-process and finished product samples for stability testing and analysis.

Pre-formulation and formulation development activities to achieve stable sterile liquid/lyophilized injectable clinical drug products with emphasis on biologics, small molecule and nab (TM) technology.

Discovery and research phase to development and commercialization a revolutionary new technology of creating protein-bound nanoparticles that are suitable for in vivo delivery of a potentially broad range of drugs.

Practical experience in Biologics formulation and delivery utilizing multiple physical, chemical and conformational stability attributes.

Lyophilized protein-bound Injectable formulation suspension Physical and Analytical testing (Particle-size, pH, Purifications, UV-Vis, Zeta potential analysis, Color measurement and Moister-test).

Moist Heat Sterilization (Autoclave Sterilization) of injectable substances.

BAXTER HEALTHCARE CORPORATION Jan 2002 - Jan 2008

Analytical Researcher Associate II

Major Project: NANOEDGE® (Injectable Formulation Technology Laboratory and Pilot Plant) Operated and maintenances Particle Science and Morphology Lab used NANOEDGE® research and develop nano-enabled drug formulation to lower drug toxicity, reduce cost of treatments, improve bioavailability and to extend the economic life of proprietary drugs.

Sponsor by: Baxter International, Sanofi-Aventis, Abbot Laboratory, Pfizer, Bayer, GlaxoSmithKline, Merck & Co., Bristol-Myers Squibb, Eli Lilly and Co., Schering-Plough.

Adaptations and modifications of standard technical principles for nano-suspensions.

Instrumental and optical particle sizing Method development, evaluation and validation for pharmaceutical micro and nano-suspensions formulation.

Support Laboratory research and Pilot Plant manufacture scaled-up Nano-enabled drug injectable formulation suspension.

Nano-suspension physical stability monitoring - microscopy examination and static/dynamic laser-light diffraction measurements and stability testing.

Liaison with major equipment manufacturers for modified the light transmission range requirements for a number of drugs, including color compounds.

EDUCATION

Bachelor of Science in Computer Science & Information Systems

DePaul University Chicago in Computer Science

Chemistry Loop College of Chicago

CERTIFICATIONS/LICENSES

Microscopy Mar 2002 to Jul 2005

Digital and Video Microscopy, Applied Polarized Light Microscopy, Photomicrography (I, II)

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