John Pu

Thousand Oaks, CA

ad2e06@r.postjobfree.com

Tel: 747-***-****

Professional Experience

Amgen (Thousand Oaks, CA) Jan 2022 to May 2023 Process Development Sr. Assoc Scientist

Develop safe, robust and transferable process for various intermediates and APIs to deliver the desired physical and chemical properties that can be transferred to manufacture

Executions of bench/kilo laboratory experimentation and process modeling/simulation to design and optimize batch process

Technology transfer for various project of synthetic processes

Laboratory equipment set-up and maintenance for Chemglass reactors, HTE equipment, Easy max, ReactIR etc

Info-tree at Amgen April 2019 to Jan 2022

Sr. Engineer

Technical lead of Neulasta® for successful validation batches campaign.

Investigated manufacture process of Neulasta API intermediate to identify the root cause of the failing batch that lead to successful commercial production batches.

Developed a scalable robust crystallization method for cancer drug candidate that improve impurities control and 35% more yield increase.

Develop safe, robust and transferable process for various intermediates and APIs to deliver the desired physical and chemical properties that can be transferred to manufacture

Author and review process documentation needed for process validation and commercialization

Supported various projects for PDSR, FMEA, PTD and process validations

NewLink Genetics. (Ames, IA) March 2016—Sept 2018

Senior CMC Project Manager

Externalizations lead for two assets within company’s synthetic portfolio. Successfully managed a global and diverse net work of six CMOs to ensure supplies of drug substance, starting materials, intermediates and API that meet quality, cost and cycle time targets for Ph2/Ph 3 clinical study.

Led contract site selection recommendations as part of cross-functional product delivery team, including drug substance, drug product, analytical sciences, supply chain, quality assurance and regulatory group

Provided technical lead for drug substance (DS) manufacturing through CMOs that led to successful commercial campaigns.

Authored regulatory CMC documents including Module 3 for IND applications resulting in acceptable multiple US, Canada and EU submissions.

Eli Lilly and Company (Indianapolis, IN) 2015-2016

HUMALOG API Technical Service Consultant

Primary process owner at unit operation level, integrating process and identifying better optimization technologies, provide a science-based approach for the resolution of investigations, deviations and process issues

Served as SME for Insulin process to improve yield, product quality and system reliability

Worked with QA team during FDA audits and in providing responses to process related questions

Eli Lilly and Company (Indianapolis, IN) 2000-2015 Chemical Process Research and Development: Consultant Chemist

Conducted API process research and development for multiple projects. Synthesized many high-value intermediates, metabolites, and degradants to support for analytical and bio-analytical studies. Defined optimal methods for in-process monitoring and collaborated with analytical chemists to identify structure and origin of process impurities.

Initiated in-house process research. Saw opportunity to save time and money by doing process research in-house before transferring new techniques to CMO. Developed crystallization method to isolate potential impurities. Superior quality product to support for analytical and bioanalytical studies. Cut R&D related CRO costs.

Saved costs. Scaled up cGMP batches using in-house equipment. With technical expertise in process control testing and using the RC1 to analyze reaction condition and by doing it in-house, saved department 30% in outsourcing costs and made product ready for pilot plant.

Developed an efficient crystallization method to purify and isolate degradants and metabolites for API studies. • Provided the optimized lab procedure for scale up production, ensured the alignment of safety, technical, and quality elements, successfully delivered 10 different APIs at 50-500 kg scales. Given seven awards by Lilly including green chemistry reward, enabling candidate selection and team player.

Created Design of Experiment (DOE) study for impurity control purpose, implemented the information to support manufacturing.

Experienced on parallel reactors, 22L, 50L reactor, DOE, cGMP pilot plant production, handling high pressure equipment, Biotage Preparative LC system, empower LIMs, LC-MS, HPLC, NMR, FT-IR, UVVis, DSC, TGA, microscopic and X-ray crystallography

Brantford Chemicals Inc., Canada 1999—2000

Research Chemist

Led chemical process development for multiple drug substances and intermediates for kilo-lab and pilot plant scale, purified drug substances and intermediates from milligram to hundred-gram levels through column chromatogram.

Performed GMP 25 L scale batch to produce Cytotec drug substance;

Performed an engineering process at 1000 g scale to purify Cytotec drug substance through high pressure column chromatography

Education

MS in Chemistry, University of Mississippi

BS in Chemical Engineer, Zhejiang University

Publications and Presentations

1.Vaid, R. K; Boini, S.; Spitler, J. T.;Pu, J. Y.; May, S. A.; Yu, H.; Wu, S.; Fu, J.; Zhang, L. Synthesis of (2-{4-[4-Fluoro-3-(trifluoromethyl)phenyl]-2-piperidin-4-yl-1H-imidazol-1-yl}ethyl)dimethylamine, Synthesis2013,45(11), 1534.

2.Magnus, N.; Pu, J.; Coffey, S.; DeBaillie, A.; Jones, C.; Kluzna, I.; Kambourakis, S.; Wang, L.; Wepsiec, J. “Diarylketone Ketoreductase Screen and Synthesis Demonstration to Access mGlu2 Receptor Potentiators”, Org. Process Res. Dev.2011, 15 (6), 1377.

3.Pu, J.; Vaid, R.; Boini, S.; Towsley, R.; Doecke, C.; Mitchell, D. “A Practical Method for Functionalized Peptide or Amide Bond Formation in Aqueous-Ethanol Media with EDC as Activator”, Org. Process Res. Dev.2009, 2, 310.

4.Bender, D.; Bao, J.; Dantzig, A.; Diseroad, W.; Law, K.; Magnus, N.; Peterson, J.; Perkins, E.; Pu, J.; Reutzel-Edens, S.; James J. Starling, J.; Stephenson, G.; Vaid, R.; Zhang, D.; McCarthy, J. “Synthesis, Crystallization, and Biological Evaluation of an Orally Active Prodrug of Gemcitabine”, J. Med. Chem.2009,52 (22), 6958.

5.Xie, C.; Sullivan, K.; Laurila, M.; Mitchell, D.; Pu, J. “Selective Monoarylation of Benzenediols via Dianion Intermediates”, Synth.Commun.2008, 38: 21.

6.Wan, Z.; Jones, D. C; Koenig, T. M.; Pu, Y. J.; Mitchell, D.; “Vinyl Aryl Ethers from Copper-Catalyzed Coupling of Vinyl Halides and Phenols”, Tetrahedron Lett.2003, 44, 8257.

7.Wan, Z.; Jones, C.; Mitchell, D.; Pu, J.; Zhang, T.; “Practical Method for Transforming Alkynes intoDiketones”, J. Org. Chem. 2006, 71, 826-828.

8.Pu, J.; Mitchell, D.; Wan, Z.; Koenig, T. M. “Practical Ligands for Copper-Catalyzed Ether Forming Reactions”, ORGN # 401 225th ACS National Meeting, New Orleans, LA, 2003.

9.Author of 40 internal and external publications.

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