Quality Control Manufacturing

Kevin Fitzpatrick Ph.D. *****.**************@*****.*** 518-***-**** San Antonio, TX

QUALITY CONTROL AND PILOT SCALE MANUFACTURING

Chemistry Manufacturing & Controls Quality Assurance & Control Operations Management

Quality-Oriented Leader with more than 21 years in research roles in the pharmaceutical manufacturing industry with over seven years operations management experience overseeing quality, compliance, business development and project management. Proven ability to budget, develop and introduce new commercial scale manufacturing routes with a focus on continuous improvement. Strong knowledge in good laboratory / manufacturing practices (cGLP, cGMP), standard operating procedures (SOPs), chemistry manufacturing and controls, quality control processes and audits, corrective and preventative actions (CAPA) with the demonstrated capacity to mentor and lead a team of professionals.

- CORE COMPETENCIES -

Quality Control (ISO 9000)

Technical Leadership

Business Development

Chemical Synthesis/ Optimization

Process Management

Strategic Planning

Safety Evaluation

Statistical Analyses

Chemical Operations

Medicinal and Process R&D

Bid Preparation

SOP Process

- PROFESSIONAL EXPERIENCE –

Southwest Research Institute San Antonio January 2016-Feb 2017

Assistant Manager Pilot Plant Operations 2016-2017

Privately owned non-for Profit (3000 employees) chemical contract research/manufacturing organization serving the and pharmaceutical / biotech sectors with batch manufacturing operations up to 50-gallon scale. Responsible for scheduling and implementing pilot plant production as well as overseeing aspects of ISO 9000 quality system requirements including batch records, environmental monitoring, waste management. Assess new business opportunities with new and existing clients, continuously monitor and improve existing processes, strive for cost and time synergies without impacting quality of key intermediates or finished drug substance.

oManaged multiple “pre-commercial scale” productions of either critical intermediates or final drug substance. These materials were for commercial clients requiring cGLP/cGMP drug substance (API) either preclinical studies or early phase (1-2) human clinical trials. These typically were 3-6-month short term projects with a value of around $500,000

oProvided production support and (pre) clinical grade drug substance material for multi-million-dollar Government programs targeting chemical counter measures against Ebola and Marburg viruses.

oIdentified and worked with potential clients to provide targeted services (contracts in $100,000-2MM range) to address unmet needs for treatments targeting therapeutic areas such as cardiac care, Attention-Deficit Hyperactivity disorder (ADHD) and pain management.

RSA Corporation Danbury, CT March 2010-Dec 2015

Laboratory Director 2010-2015

Small privately owned chemical contract manufacturing organization serving the chemical, electronics, fine chemical, flavorings and pharmaceutical / biotech sectors and the fire retardant industry with batch manufacturing operations up to 2,000-gallon scale. Responsible for scheduling and implementing laboratory production up to 72 liters in scale. Oversee the quality control department and co-lead audit operations. Assess business opportunities.

o$5 million in gross sales achieved over a five-year period by completing 50 audits with federal and state organizations with minimal findings and resolving all observations to the satisfaction of the auditor.

oPartnered with a client in the investigation of a new blend of an existing product for commercialization with a multimillion-dollar downstream value.

o$750,000 annual revenue stream retained by adapting projects to meet the needs of the end user.

o$500,000 in gross sales generated in 2015 by developing a manufacturing process that increased in scale from four kilograms to 1,200 kilograms.

o$15,000 decrease in operating costs realized by renegotiating the requirement of a quality agreement with an auditor from a pharmaceutical firm.

Principal Chemist 2010-2011

Conducted chemical synthesis and manufacturing support for plant operations.

o$200,000 in yearly sales revenue produced by concluding a process validation assessment of a modified route to an existing active pharmaceutical compound

o20% of annual revenue recaptured by using a product waste stream when global geopolitical events disrupted the supply of a key raw material, iodine.

AMRI Albany, NY 1998-2009

Senior Research Scientist (DR&D)

Pharmaceutical / biotechnology contract research organization with research and manufacturing sites across three continents, providing active pharmaceutical intermediates and drug product manufacturing operation. Devised and synthesized a variety of medicinal chemistry compounds. Coordinated project reporting, patent filing and shipment documentation. Established a chemical inventory storage system. Supervised two research chemists.

o$5.5 million milestone payment engendered by developing new compounds as a member of the ADHD project team.

oFour publications attained by contributing target compounds to three therapeutic areas.

oServed as a member of the departmental taskforce to evaluate new therapeutic research areas and validate new or improved target scaffolds for projects-in-process. Page 2 of 2

Senior Research Chemist Medicinal Chemistry 1999-2004

Worked in therapeutic areas including BACE inhibitors as a treatment for Alzheimer’s, thrombin inhibitors for anticoagulant therapies, novel tetrahydroisoquinoline compounds as ADHD therapy agents. Conducted design, synthesis, purification, identification and shipment of target compounds. Performed analysis of structure-activity relationships (SAR).

o$200,000 in chemical inventory charges saved by reorganizing and centralizing the medical chemistry department stock of chemicals. Eliminated degraded chemicals to enhance storage safety and productivity.

oMentored junior colleagues in the department on safety, chemical problems and safe work practices in the lab.

oTwo publications and one patent obtained by developing a manufacturing process that resulted in an experimental drug that successfully completed phases one through three of human clinical trials.

Senior Research Chemist Chemical Development 1998-1999

Resolved chemical problems to develop viable large-scale manufacturing process, deliver multi-hundred gram batches for subsequent biological testing. Involved in the design, synthesis, purification and identification of chemical intermediates and target compounds.

oSynthesized individual compound deliverables promptly and cultivated viable ideas for team members with challenging chemical syntheses.

oAuthored, proofed and edited technical information to ensuring correct usage of the English language of all teammate reports for compilation into one monthly team report to the client.

-EARLIER CAREER EXPERIENCE-

Syncom BV Groningen, The Netherlands

Research Chemist

Chemical contract research organization specializing in small-scale manufacture of active pharmaceutical ingredients. Responsible for synthesis of client-assigned medical chemistry targets.

oSustained a high productivity level of deliverables on small amounts of highly potent steroid compounds and multikilo scale-up work for advanced active pharmaceutical intermediates.

oProof read and edited all Dutch-speaking colleague reports written for US and UK clients

- EDUCATION & CERTIFICATIONS -

Doctorate in Organic & Organometallic Chemistry, Oxford University, UK

Bachelor of Science in Chemistry, Swansea University, UK

Post-Doctoral Fellowship in Chemistry & Organic Synthesis, Swiss Federal Institute of Technology, Switzerland Post-Doctoral Fellowship in Chemistry & Asymmetric Catalysis, University of Groningen, The Netherlands

- AFFILIATIONS -

American Chemical Society, Member

- SELECT PUBLICATIONS -

The Design and Synthesis of Novel SGLT2 Inhibitors, C Glycosides with Benzyltriazolopyridone, and phenylhydantoin as the aglycone moieties." Bioorganic & Medicinal Chemistry 2014, 22, 3414-3422.

Novel Serotonin Type-3 Receptor Partial Agonists for the Potential Treatment of Irritable Bowel Syndrome, Bioorganic & Medicinal Chemistry Letters 2011, 21(1), 58–61.

Discovery of 2-Substituted Benzoxazole Carboxamides at 5-HT3 receptor Antagonists, Bioorganic &Medicinal Chemistry Letters 2010, 20(22), 6538–6541

Five Functionalized Indazoles as Glucocorticoid Receptor Agonists, Bioorganic &Medicinal Chemistry Letters 2010,

20(10), 3017–3020

*****.**************@*****.*** 518-***-****

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