Project Management

Sean Leo Moro, Ph.D.

****.*.****@*****.*** • *** Verano Place, Irvine, CA 92617 • 617-***-****

SUMMARY OF QUALIFICATIONS

Self-motivated and collaborative structural biologist with excellent analytical, writing, and problem-solving skills, extensive experience in GMP/GLP/CLIA regulated quality and compliance activities in industries such QC of protein pharmaceuticals, clinical laboratory testing of tumor samples, and product complaints for intraocular lenses. I am experienced in scientific writing and analysis of very complex research data, with the ability to distill the core message of the research, while ensuring the written material is complete, accurate, and clearly presented. My prior industry roles in involved review of many technical documents

(SOPs, product complaints and specifications, regulatory submissions) for completeness and accuracy. These activities demonstrate my sharp attention to detail and analytical skills. In addition, I have collaborated with cross-functional teams in industry to ensure execution of project team goals, establishing relationships with colleagues to meet targets and deadlines. In summary, I have ensured compliance and organization success in multiple regulated environments, achieved through building relationships with co- workers and I also bring my excellent technical writing ability and depth of scientific knowledge to this role. EDUCATION

University of California, Irvine, Irvine, CA Sep 2011-Oct 2015 Ph.D., Molecular Biology & Biochemistry

Dissertation Title: “Characterization of the dynamics and thermostability of a translesion DNA polymerase” Brandeis University, Waltham, MA, B.S., Biology, Cum Laude Aug 2005-May 2008 Springfield Technical Community College Aug 2004-May 2005 RELEVANT SKILLS

Organization, project planning & management Expertise in biochemistry & molecular biology

Scientific writing and presentation Expertise in DNA repair & polymerase function

Revising and editing SOPs & product specifications Building relationships and collaborations to

Cross-functional communication in industry achieve project goals

Expertise in MS Word, Excel, Adobe Acrobat, Adobe Illustrator, EndNote, and other visualization software

Analysis of massive, complex data sets

Attention to detail, excellent at proofreading

Data review for regulatory submissions Can master new tasks with minimal supervision PROFESSIONAL EXPERIENCE

Bausch + Lomb, Aliso Viejo, CA

Global Product Surveillance and Safety Associate

Jul 2010-Aug 2011

Evaluated product complaints for implantable lenses for reportability to FDA

Collaborated with colleagues in department reorganization project which eliminated complaint backlog

Maintained electronic and physical copies of complaint archives in compliance with FDA regulations

Communicated with medical care providers to ensure complete and accurate documentation of complaints Exiqon Diagnostics, Tustin, CA (location closed Jun 2010) Document Control Specialist

Sep 2009-Jun 2010

Managed document system including SOPs and safety manuals to adhere to CAP/CLIA regulations

Reviewed patient information for accuracy and completeness to ensure proper testing was performed

Assisted management with CAP self-inspection meetings to identify areas for process improvement Shire Human Genetic Therapies, Lexington, MA

Quality Control Coordinator

Aug 2008-Jul 2009

Revised and created product specifications for protein pharmaceuticals

Verified completion of QC testing for product lots to generate Certificates of Analysis for release to market

Reviewed, entered, and edited QC and stability program data for regulatory submissions, ultimately resulting in the NDA submission for velaglucerase alfa and eventual FDA approval

Monitored metrics and data to ensure QC met testing timelines for product release

Transitioned physical records of QC data into LIMS electronic database as part of cross-functional team

Assisted in relocation of QC laboratories to Lexington resulting in FDA approval of the new site

Collaborated with QA to ensure proper execution of change controls and CAPA within QC TEACHING EXPERIENCE

University of California, Irvine, Irvine, CA

Graduate Teaching Assistant

Jan 2012-Sep 2015

Taught a wide variety undergraduate and graduate level lecture and lab courses including: o Microbiology lab:

o Organic chemistry lab

o Advanced biochemistry & molecular biology:

o Protein & nucleic acid structure & function:

Challenged students to think critically, formulate hypotheses, and scrutinize data

Trained students in proper scientific writing to improve writing quality by the end of the course

Led students through safety procedures and proper laboratory techniques and providing correction and guidance as needed

Tutored graduate student one-on-one resulting in passing of a required course Cambridge Tutoring and Test Prep, Laguna Beach, CA Tutor

Aug 2009-Jun 2010

Provided one-on-one tutoring for 7th to 12th grade students, in math, science, and standardized test prep BUSINESS TRAINING

SciPhd: The Business of Science for Scientists, Irvine, CA Jul 2015-Sep 2015

Training in core business competencies necessary for the transition from academia to industry, including training in the following specific areas

o Strategic project management: defining scope, benchmarking, identifying critical path and execution o Leadership styles

o Team performance tools: process mapping, best practices, brainstorming, priority matrices o Personnel development: Communication, delegation, negotiation, social and emotional intelligence PUBLICATIONS AND PRESENTATIONS

Publication: “1H, 13C, and 15N backbone resonance assignments of the full-length 40 kDa S. acidocaldarius Y- family DNA polymerase, dinB homolog”, Biomolecular NMR Assignments, Vol. 9, Issue 2, pgs. 441-445 Published Oct 9, 2015. DOI: 10.1007/s12104-015-9626-y Manuscripts in Preparation:

1. “Structural response of thermophilic Y-family polymerase Dbh to temperature change: by hydrogen deuterium exchange NMR and cold denaturation studies”

2. “Picosecond-nanosecond dynamics of Y-family polymerase Dbh by nuclear spin relaxation and molecular dynamics simulation”

Presentations:

Research in progress, University of California, Irvine; Irvine, CA o “Backbone Dynamics of a Y-family polymerase” March 2015 o “Backbone NMR assignment of a Y-family polymerase” May 2014 o “Recombinant expression and Purification of Nogo-18” May 2013

UCI Molecular Biology and Biochemistry Retreat; Lake Arrowhead, CA o “Backbone Dynamics of a Y-family polymerase” March 2015 AWARDS

Dean’s List, Brandeis University: Fall 2005, Spring 2007, Fall 2007, Spring 2008

Dean’s List, Springfield Tech CC: Fall 2004, Spring 2005

CRC Freshman Chemistry Award – Top Chemistry Student, Springfield Tech CC, 2004-2005

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