Regulatory Affairs Senior Manager

Joseph Duran

Chicago, IL ***** *********@*****.*** www.linkedin.com/in/joseph-duran-scientist

Senior CMC Manager

Senior Manager CMC with 30 years of increasing responsibilities in the pharmaceutical industry. Experience in regulatory affairs, both in the health authority (FDA) and private industry sectors. Expertise in managing drug development from lab scale to tech transfer at manufacturing sites. Proven track record in leading cross-functional teams, performing global regulatory assessments, navigating FDA regulations, and facilitating technical transfers to international manufacturing sites. Recognized for exceptional contributions in regulatory compliance and scientific innovation, including co-inventorship of patents and successful development of pharmaceutical products.

Areas of Expertise

Regulatory Compliance CMC Strategies Project Management Cross-functional Collaboration IND Submissions Global Assessments Technical Documentation GMP Compliance Scientific Research Chemical Synthesis Technical Transfer

Professional Experience

Pfizer Inc., Silver Spring, Maryland/Lake Forest, Illinois 2022 - 2024

Regulatory Senior Manager CMC

Served as Product Lead managing the CMC team for biosimilar Trazimera and contributed to submissions for Ruxience. Developed and implemented CMC strategies for initial submissions, post approval changes, and health authority queries to global marketing applications.

Managed complex projects with shifting priorities across multiple portfolios to meet milestones with a focus on quality and timely submissions.

Collaborated with cross functional stakeholders to support multiple projects.

Conducted global regulatory assessments on proposed CMC changes, ensuring compliance and reducing review cycles.

Prepared and submitted IND applications, contributing to the advancement of key biologics and small molecule projects.

Experienced with biologics and small molecules.

Cardinal Health, Overland, Kansas 2017 - 2022

Senior Scientist- Regulatory Sciences

Authored and strategized CMC and regulatory compliance initiatives for large pharmaceutical clients, improving submission accuracy and approval rates.

Develop and implement CMC strategies for post approval changes and health authority queries to global marketing applications, contributing to a reduction in response times.

Perform global regulatory assessments on proposed CMC changes.

Prepare, author, review and maintain global regulatory dossiers using electronic document management systems.

Authored and strategized CMC and regulatory compliance initiatives for large pharmaceutical clients, improving submission accuracy and approval rates.

U. S. Food and Drug Administration, Silver Spring, Maryland 2011 - 2017

Interdisciplinary Scientist - CDER/OPQ/OPF/DPA III

Played a critical role in the evaluation and approval of drug applications, ensuring the quality and safety of pharmaceutical products.

Reviewed primarily liquid dosage forms including sterile products.

Reviewed CMC sections of drug applications (NDA/ANDA/DMF) for approval, contributing to the timely approval of critical medications. Reviewed DMFs of peptides and carbohydrates.

Interdisciplinary Scientist - CDER/OC/OMQ/DDQ II

Utilize an understanding of the agency policies and priorities, and regulations to make decisions regarding conformance with Good Manufacturing Practices of international drug product and drug substance manufacturers.

Led case reviews leading to official actions including warning letters, import alerts, and recall of products. Reviewed primarily international cases, resulting in a significant improved compliance rates among international manufacturers.

Participated in meetings with industry regarding regulatory issues.

Received 3 certificates of appreciation.

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Additional Relevant Experience

Wayne State University, Detroit, Michigan

Research Assistant - Laboratory of Dr. Mary Kay Pflum, Biorganic/Biochemistry Research

Studied post translational modified phosphorylated protein-kinase cell function. Investigated proteomics. Synthesized modified peptides.

Arena Pharmaceuticals, San Diego, California

Scientist I - Pharmaceutical Process Chemistry Laboratory

Served as lead investigator for multiple process steps in the multi-step synthesis of Ralinepag drug substance. Prepared CGLP and CGMP supplies in a Class 10,000 environment in support of an IND, this included sourcing of raw materials and equipment.

Neurocrine Biosciences, San Diego, California

Scientist I - Pharmaceutical Process Chemistry Laboratory

Investigated the chemical development of Orillssa drug substance. Facilitated the technical transfer of a process to an international manufacturing site.

Pfizer Inc., Ann Arbor, Michigan

Scientist - Pharmaceutical Medicinal Chemistry Laboratory

Investigated the development of ion channel inhibitor resulting in co-inventorship of 2 patents. Synthesized and characterized over 200 compounds for screening of efficacy and safety. Assisted in the resolution of scale-up issues that facilitated pre-clinical supplies for the lead compound. Performed over 250 experiments/year.

Searle/Monsanto/Pharmacia, Skokie, Illinois

Scientist/Process Chemist - Pharmaceutical Process Chemistry Laboratory

Increased the yield for responsible step from 30% in piloting (10 gal reactors) to 90% (1,000 gal reactors) in validation campaigns at the manufacturing site; reducing the cost of the API by 65%. Implemented process improvements compliant with FDA’s CGMP regulations. Promoted to Scientist position.

Mullins & Associates, contracted by Searle, Skokie, Illinois

Process Chemist -Pharmaceutical Process Chemistry Laboratory

Successfully developed an alternative synthetic route and processes for a multi-step synthesis; resulting in a 62% reduction in the cost of the API. Facilitated the technical transfer of a process to manufacturing.

Education

Bachelor of Arts (B.A) Chemistry University of Chicago, Chicago, Illinois

Publications

Noel A. Powell,* Timothy J. Hagen, Fred L. Ciske, Cuiman Cai, Joseph E. Duran, Daniel D. Holsworth, Daniele Leonard, Robert M. Kennedy, and Jeremy J. Edmunds “Optimization of a Pd-catalyzed intramolecular a-arylation synthesis of tricyclo-[7.3.1.02,7]-trideca-2,4,6-trien-13-ones”. Tetrahedron Letters (2010), 51(33), 4441-4444.

Awasthi, Alok K.; Boys, Mark L.; Cain-Janicki, Kimberly J.; Colson, Pierre-Jean; Doubleday, Wendel W.; Duran, Joseph E.; Farid, Payman N. “Practical Enantioselective Synthesis of b -Substituted-b -amino Esters.” Journal of Organic Chemistry (2005), 70(14), 5387-5397.

Duran, Joseph E., Summit R. Mahasay, and Leon M. Stock, !The occurrence of elemental sulfur in coals,” Fuel, 65, 1167 (1986)

Stock, Leon M., Joseph E. Duran, Michael G. Noel, and, Vijay R. Srinivas, !The influence of sulfur-containing compounds on the donor solvent dissolution of Illinois coals,” Fuel Process Technology, 12, 287 (1986)

Stock, Leon M., Joseph E. Duran, Chorng-Bao Huang, Vijay R. Srinivas, and Ried S. Willis, !Aspects of donor solvent coal dissolution reactions: Effects of organosulphur compounds on hydrogen transfer, decomposition of 1,3diphenylpropane and liquefaction of Illinois coals,” Fuel, 64,754 (1985)

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Patents

Cai, Cuiman; Ciske, Fred Lawrence; Duran, Joseph Edward; Fors, Kristina Sean; Hagen, Timothy Joseph; Holsworth, Daniel Dale; Jalaie, Mehran; Kennedy, Robert Michael; Leonard, Daniele; Poel, Toni-Jo; Quin, John, III. Preparation of 1,4-dihydronaphthyridine derivatives as therapeutic calcium channel antagonists. PCT Int. Appl. (2009) 61pp. CODEN: PIXXD2 WO 200-***-****.

Cuiman, Cai; Duran, Joseph E.; Fors, Kristina Sean; Hagen, Timothy Joseph; Holsworth, Daniel Dale; Jalaie, Mehran; Leonard, Daniele Marie; Poel, Toni-Jo; Quin, John, III; Take, Yukinori. Preparation of substituted oxadiazole analogs as calcium channel antagonists. PCT Int. Appl. (2008), 150pp. CODEN: PIXXD2 WO.

Behling, James Richard; Boys, Mark Laurence; Cain-Janicki, Kimberly Jo; Colson, Pierre-Jean; Doubleday, Wendel William; Duran, Joseph Edward; Farid, Payman N.; Knable, Carl Matthew; Muellner, Frank Walter; Nugent, Sean Thomas; Topgi, Ravindra S. Asymmetric synthesis of chiral b - amino acids. U.S. (1998), 18 pp. CODEN: USXXAM US 5840961.

Behling, James R.; Boys, Mark L.; Cain-Janicki, Kimberly J.; Colson, Pierre-Jean; Doubleday, Wendel W.; Duran, Joseph E.; Farid, Payman N.; Knable, Carl M.; Muellner, Frank W.; Nugent, Sean T.; Topgi, Ravindra S. Asymmetric synthesis of chiral b -amino acids. PCT Int. Appl. (1998), 75 pp. CODEN: PIXXD2 WO 9802410.

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