Shirley Louise-May, Ph.D.

** ***** ****, ********, ** 06437

Cell: 203-***-**** Email: acukf2@r.postjobfree.com

LinkedIn: www.linkedin.com/in/slouisemay

Rich and current expertise in technical communications, NPD documentation, technical user’s guides, and business/marketing materials. Motivated, analytical and organized freelance technical writer looking to facilitate efficiency and high standards in the technical communication needs of a global health care leader. Proactive communicator in team settings, flexible strategist and adept trouble-shooter. Strengths in clear, concise and simple translation of highly technical concepts, editing for quality standards, exceptional compliance to internal audit standards, organization of team resources for completion of draft reviews, ability to meet tight deadlines, and surpassing expectations for completion of assigned projects.

Experience Summary

7 years (2009-present) freelance contracted (W-1099) technical writing and editing experience managing all aspects of document development, including leading project teams, proposing content themes and layout, creation of style sheets, coordination of draft reviews, publication management, and coordinating document release.

Led 2 successful large technical documentation projects involving hardware and software SOPs for biotechnology applications spanning cheminformatics platforms to gene sequencing hardware developed for Unix operating systems.

Demonstrated publishing record of primary research articles and reviews focused on preclinical pharmaceutical discovery strategy and methods development with an emphasis on computational methods in toxicology.

Practiced as a senior managing editor for desktop publishing of periodic departmental research summary newsletter.

Experienced in marketing / business development of cloud-based / web-hosted computational discovery tools and services via promotional materials (brochures, overview slide-decks, white papers) and social media posting.

Specialized in statistical analysis and data visualization. Coding skills in Perl, SAS, R and Python.

Trained and experienced on Windows, Unix and Linux operating systems with basic administrative task knowledge.

Trained and experienced with Oracle SQL database operations, SAS and R statistical analysis coding, Pipeline Pilot script generation, SpotFire Data Analysis, Excel Spreadsheet advanced operations.

Trained and experienced in Adobe products for documentation and publishing (Acrobat). Create, revise, edit, and format of product documentation experience using Microsoft Office applications for documentation editing and publishing (version control, merging multiple edits, TOC, Appendices, graphics embedding), report and brochure design (layouts, building templates), graphics creation (process flowcharts, illustrations, logo design), PowerPoint poster and slide deck presentations with embedded dynamic elements (links, animations, videos).

Projects Successfully Executed

Mar 2015-present; Currently contracted for individual projects covering content, format and layout creation of marketing/business development electronic brochures and presentation materials for Quantitative Medicine’s CoRE Platform (www.QTMed.com), a web-hosted machine learning computational modeling discovery application (examples here and here.)

May 2015 – present; Currently contracted for proposal and execution of social media marketing articles for Collaborative Drug Discovery (CDD) web-hosted database and applications including, but not limited to, first person reporting of CDD public symposia (example here) and spotlight interviews with client scientists (example here).

Jan 2015 – present; Biotechnology Partnering Consulting, NewWave Consulting, LLC providing project proposals for evaluation of Quantitative Medicine’s CoRE Platform for prospective clients and collaborators.

Sept 2012-Dec 2014; Chief Editor for the Compound Safety Prediction (CSP) Department Bi-monthly Global Pfizer research update newsletter covering department research progress on preclinical development safety initiatives. Each edition was planned and executed in a 4-week timeframe and covered 4-6 articles authored by department researchers. I proposed each issue content theme and supporting article subject matter, solicited contributions, assigned editorial review to my team of 6 peers and coordinated the article final drafts into the layout template for final review and release by the team. The newsletter was distributed globally in varied electronic and printed editions in a magazine layout format with extensive analytical graphics and multi-media hyperlinks.

Aug 2009-Dec 2104; Principal Research Scientist, Pfizer, Inc., Groton CT 06340

May-Aug 2009; Project management and chief editor for major revisions of 454 Life Science’s Genome Sequencer Software Data Analysis Manuals, both paper and electronic formats, for product launch of September 2009 (3-month contract / deadline). Revision included hardware and software methods updates, reorganization and significant addition to the content which included summaries of the theoretical background and scientific principles underpinning the application methods I derived from primary interviews conducted with the principal methods development scientists. The finished electronic manual was ca. 400 pages, covering five separate core data analysis applications and multiple supporting tools and modules used to sequence, process and assemble physical DNA and RNA samples into the linear sequence and sequence variation information contained therein. Documentation drafts were written in Word with extensive hyperlinks and indexing for conversion to a first edition electronic format using RoboHelp8.

Jan – May 2009; Freelance technical writer, NewWave, LLC with contracted projects for GraphLogic (technical documentation) and Collaborative Drug Discovery (NIH SBIR Grant Applications).

Jan – Dec 2008; Senior Scientist, Cara Therapeutics, Shelton CT 06484

Nov 2002 – Dec 2007; Senior Scientist, Achillion Pharmaceuticals, Inc., New Haven CT 06511

Jun 1999 – Aug 2000; Project management and chief editor of 1st and 2nd editions of Neurogen’s five volume Accelerated Intelligent Drug Design (AIDD) platform product user’s manual. I coordinated, edited and formatted the work of 14 contributors to complete the initial project over 4.4 months, three weeks ahead of schedule. The second edition, with addition of two new software application modules and updates to all existing modules, was completed in 6 weeks total. Neurogen licensed the AIDD platform to Pfizer in 2000 for $29M.

Nov 1998 – Oct 2002; Senior Scientist, Neurogen Corporation, Branford CT 06405

Biotechnology Partnering Consulting, NewWave Consulting, LLC (Jan 2015-present)

As an experienced computational chemist and toxicologist capitalizing on extensive drug discovery research experience in pharmaceutical and biotechnology companies, I support pharma, biotech and academic research technology and project leads that have an appreciation for cutting edge collaboration in their adoption of technologies, strategies and philosophies that catalyze insights and propel research progress in their therapeutic discovery endeavors.

I offer therapeutic drug development strategy understanding from target de-risking to early in vivo safety studies. Additionally, I have extensive preclinical discovery/safety expertise across therapeutic areas from senior research scientist and project manager positions in both major pharma and small biotechnology. I have a strong base of knowledge from formal education in chemistry, molecular biophysics, computational modeling and statistical analysis.

I have worked with individuals, biotechnology companies and global organizations in both private and non-profit sectors. I am highly adaptable to the unique needs of each company or project to effect a powerful transformative discovery strategy in close consultation with therapeutic area project teams.

Biotechnology and Pharmaceutical Research Scientist Positions

2009-2014 (5 years) Principal Scientist, Pfizer, Inc., Groton CT 06340

oA senior member of a multi-disciplinary compound safety department charged with development of strategies to address early drug discovery compound attrition rates

oI integrated and leveraged biology, chemistry and toxicology disciplines to identify, develop and apply predictive models to progress project series and compounds from leads to preclinical candidates.

oI coordinated the team’s efforts in establishing SOPs for developing predictive models from safety biomarker assay data and I designed and constructed key project data sets for the team through multi-dimensional data-mining of preclinical animal model safety data.

oI established a safety risk scoring system of in vivo toxic effects that, for the first time, allowed quantification of safety animal studies enabling their use in predictive model development for translation of in vitro to in vivo toxic effects. Implementation of this scoring system facilitated training of a multivariate preclinical safety assessment model currently employed globally in Pfizer therapeutic projects.

oAdditional safety projects under my direction included assessment of in vitro to in vivo translation of ligand kinase activity signatures, development of predictive models for bone marrow toxicity and identification of in vivo preclinical biomarkers of mitochondrial toxicity.

2008 (1 year) Senior Scientist, Cara Therapeutics, Shelton CT 06484

oThe singular computational chemist at Cara Therapeutics who provided computational modeling support of drug discovery efforts towards the development of novel therapies for GPCR-modulated non-CNS pain and inflammation targets.

oI worked from within the chemistry department to support ten medicinal chemists working across multiple projects spanning lead discovery to preclinical profiling activities for three separate peripheral pain targets; CB1, CB2 & Kappa Opiod.

oI worked across technology departments to provide analysis of high throughput screening data, to build predictive ADME/PK models of focused lead series, and to aid our patent and IP counsel in the preparation of novel chemical patents.

oThe results of my discovery project support activities and predictive modeling initiatives were presented regularly at project team meetings and directly to the Cara management at senior level meetings.

2002-2007 (5 years) Senior Scientist, Achillion Pharmaceuticals, Inc., New Haven CT 06511

oI provided computationally derived molecular design ideas in support of early lead discovery efforts and preclinical lead series optimization for antiviral HIV, HCV and antibacterial targets leading to inclusion on two patents of novel active series.

oI co-developed and applied a novel in-house pharmacophore perception method for automated hypothesis generation, ranking and evaluation. Applied to HIV-I targets, this method enabled me to propose new, pharmaceutically developable molecular scaffolds which were subsequently validated by in vitro activity in the micromolar potency range.

oI applied structure based drug design approaches for novel antibacterial targets, developing and utilizing protein homology models in virtual docking experiments.

oEfforts towards optimization and profiling of lead series involved non-linear model building of potential ADME and PK liabilities for hERG activity, cytochrome P450 interaction, absorption character, protein binding and serum effects.

oI was integral to the in-house design, development and deployment of multiple discovery informatics interfaces for medicinal chemist and discovery scientist use; WebChemCalc – a web based molecular property calculator, PSTS – a preclinical studies tracking system and search engine, and ACE – the Achillion Cheminformatics Engine web interface to tools for simple molecular modeling experiments.

1998-2002 (5 years) Senior Scientist, Neurogen Corporation, Branford CT 06405

oAs part of a small but focused computational chemistry and informatics group, I assisted in the development and launch of AIDD, the Accelerated Intelligent Drug Design platform which was licensed to Pfizer in 2000 for $29M.

oI was responsible for the design, programming and validation of a recursive partitioning predictive modeling module written in object oriented Perl.

oI managed the high speed synthesis (HSS) reaction database and maintained the AIDD Virtual Compound Library.

oI acted as the head documentation editor for initial creation and update revisions of the AIDD Platform Hardware and Software Training Manuals.

oI provided AIDD on-site training at two Pfizer sites; Groton, CT and Canterbury, UK.

oI concurrently supported 2-3 AIDD GPCR novel target HTS screening projects for lead discovery of CNS active compounds.

oI built predictive models of ADME solubility and permeability data for development optimization of lead chemical series in several discovery projects.

Education

Wesleyan University, Department of Chemistry, Doctorate of Chemical Physics and Biophysical Chemistry

Columbia University, Department of Chemistry, M.A. Physical Chemistry

University of Maine, Department of Chemistry, B.S. Chemistry

References available upon request

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