Project Management
Resume:
Joseph Dajcs, Ph.D.
**** **** ***** **., **** Worth, TX 76116
Linkedin.com/in/josephdajcs ******@*****.***
CAREER PROFILE
A highly accomplished, self-motivated professional with expertise in drug discovery and development at a Fortune Global 500 Company. Successful in collaborative relationships, building trust, and executing business plans focused on key stakeholders across divisions. Possesses strong verbal and written communication skills and high drive towards achievement of strategy, vision, and goals. Solid track record of successfully leading pre-clinical studies and authored regulatory submissions that have advanced compounds to clinical trials and FDA approvals. Strong technical, analytical, communication, leadership, and managerial skills. Currently pursuing PMP (project management) certification. Proven expertise in:
In vivo/in vitro Ocular and Otic Models
Compendial Microbiology Testing
Drug Discovery and Development
Managing Direct Reports
Technical Project Management and Leadership
FDA Submissions (IB, IND, NDA)
Data Analysis and Presentation
Managing Laboratory Operations
PROFESSIONAL EXPERIENCE
Alcon Laboratories/Novartis - Fort Worth, TX 2003 - 2016
Project Lead – Safety Microbiology 2013 – 2016
•Provided microbiological compendial testing (United States Pharmacopeia and European Pharmacopeia) of pharmaceutical products (raw materials, in-process and final product) for project teams.
•Expertise in sterility testing, preservative effectiveness testing, bioburden, endotoxin, microbial limits and other compendial tests including validation.
•Developed and led pre-clinical in vivo studies for evaluation of topical antibiotic formulations. Outcome of studies resulted in project elevation and selection of a formulation for proof of concept (PoC) clinical studies. Preclinical data were presented to internal overnance bodies, key opinion leaders, and included in FDA submissions (Investigator’s Brochure [IB], FDA type B meeting and Investigational New Drug application [IND]).
•Supported clinical study teams by providing input into study design, manual of procedures (MOP), reviewed study reports, and reviewed and edited FDA submissions (IND and NDA).
•Supported project teams by responding to health authority questions regarding microbiological testing for product submissions and lifecycle management.
•Co-authored CMC quality sections (Module 3) of various CTD submissions to US, Europe, Asia and Latin America. Co-authored technology transfers, base documents and stability reports (based on ICH guidelines).
•Business development activites include: identified compounds for licencening and evaluated potential licencing opportunities from third parties.
Manager – Anti-Infectives 2009 – 2013
•Identified and evaluated finafloxacin for the treatment of external ear infections. Received FDA approval as XTORO (finafloxacin otic suspension, 0.3%) in December 2014 for the treatment of acute otitis externa (swimmer’s ear).
•Managed six research associates resulting in motivated and highly productive teams. Management duties included hiring, performance reviews, coaching, and terminations.
•Successful project team leader that advanced antibacterial and anti-viral compound selection to PoC clinical trials.
•Developed antibacterial in vitro screening protocols and novel in vivo models for evaluating topical antibiotics.
•Provided research support for project teams including contributing to pre-clinical pharmacology sections of FDA submissions (Investigator’s Brochure, IND, New Drug Applications [NDA] and technical reports).
•Established a testing laboratory from the ground up to identify efficacious antiviral compounds for the treatment of ocular infections.
Senior Scientist III – Anti Infectives 2007 – 2009
•Analyzed data that was included in FDA submissions for the successful approval of TOBRADEX ST (February 2009).
•Co-authored the pre-clinical pharmacology sections the IB, briefing packet and IND for a compound being developed to treatment bacterial and viral conjunctivitis.
•Developed genetic based and biological assays for the detection of Staphylococcus aureus toxins in support of Phase II clinical trials.
•Produced data for presentations (oral and posters) in support of Marketing (Phase IV) efforts.
Senior Scientist II – Anti-Infectives 2003 – 2007
•Bacterial identification and characterization by phenotypic and molecular methods (PCR, DNA sequencing and ribotyping).
•Conducted research studies for detection of tissue damaging bacterial toxins (PCR, ELISA, immunoblot and hemolytic assays).
•Authored technical reports describing in vitro and in vivo results of exploratory antibiotic studies.
EDUCATION & TRAINING
Ph.D. Microbiology, Louisiana State University Health Sciences Center, New Orleans, LA
B.S. Biology, University of Michigan-Flint, Flint, MI
Management Training Classes for Research and Development – Alcon Laboratories
Center for Creative Leadership – Foundation of Leadership program
Alcon R&D Leadership Development Program
TEACHING EXPERIENCE
Louisiana State University Health Sciences Center, New Orleans, LA
Graduate Student Lab Instructor - Department of Microbiology, Immunology and Parasitology
Delgado Community College (West Bank Campus), New Orleans, LA
Laboratory Instructor – Anatomy and Physiology Laboratory II
Lecturer – Microbiology of Human Pathogens
PROFESSIONAL AFFILIATIONS
Association for Research in Vision and Ophthalmology (ARVO)
American Society for Microbiology (ASM)
PATENT
Pub. No. WO/2009/103053. Fluoroquinolone derivatives for ophthalmic applications
JOURNAL REVIEWER
•Current Eye Research
•International Journal of Cancer
•International Journal of Inflammation
•Journal of Ocular Pharmacology and Therapeutics
Publications
1.Pantůček R, Svec P, Dajcs JJ, Machová I, Cernohlávková J, Sedo O, Gelbíčová T, Mašlaňová I, Doškař J, Zdráhal Z, Růžičková V, Sedláček I. Staphylococcus petrasii sp. nov. including S. petrasii subsp. petrasii subsp. nov. and S. petrasii subsp. croceilyticus subsp. nov., isolated from human clinical specimens and human ear infections. Syst Appl Microbiol. 2013; 36:90-95.
2.Thaller MC, Borgianni L, Di Lallo G, Chong Y, Lee K, Dajcs J, Stroman D, Rossolini GM. Metallo-β-Lactamase Production by Pseudomonas otitidis: a Species-Related Trait. Antimicrob. Agents Chemother. 2011; 55:118-23.
3.Balzli CL, Bartell J, Dajcs JJ, McCormick CC, Caballero AR, Stroman D, O'Callaghan RJ.A highly virulent Staphylococcus aureus: rabbit anterior chamber infection, characterization, and genetic analysis. Invest Ophthalmol Vis Sci. 2010; 51:5114-20.
4.D'Arienzo PA, Wagner RS, Jamison T, Bell B, Dajcs JJ, Stroman DW. Comparison of fluoroquinolone kinetics of kill in susceptible and resistant gram-positive conjunctival pathogens. Adv Ther. 2010; 27:39-47.
5.Wagner RS, Granet DB, Lichtenstein SJ, Jamison T, Dajcs JJ, Gross RD, Cockrum P. Kinetics of kill of bacterial conjunctivitis isolates with moxifloxacin, a fluoroquinolone, compared with the aminoglycosides tobramycin and gentamicin. Clin Ophthalmol. 2010; 4:41-5.
6.Therese KL, Bartell J, Deepa P, Mangaiyarkarasi S, Ward D, Dajcs J, Madhavan HN, Stroman D. DNA sequencing by Microseq kit targeting 16S rRNA gene for species level identification of mycobacteria. Indian J Med Res. 2009; 129:176-81.
7.Clark LL, Dajcs JJ, McLean CH, Bartell JG, Stroman DW. Pseudomonas otitidis sp. nov., isolated from otic infections. Int. J. Syst. Evol. Microbiol. 2006; 56:709-714.
8.McCormick CC, Dajcs JJ, Reed JM, Marquart ME, O’Callaghan RJ. The effectiveness of lysostaphin therapy for experimental coagulase-negative Staphylococcus endophthalmitis. Curr Eye Res. 2006; 3:225-230.
9.Caballero AR, Marquart ME, O'Callaghan RJ, Thibodeaux BA, Johnston KH, Dajcs JJ. The effectiveness of fluoroquinolones against Mycobacterium abscessus in vivo. Curr Eye Res. 2006; 31:23-29.
10.Stroman DW, Dajcs JJ, Cupp GA, Schlech BA. In vivo and in vitro potency of moxifloxacin and moxifloxacin ophthalmic solution 0.5%, a new topical fluoroquinolone. Survey Ophthalmol. 2005; 50(Suppl):S16-31.
11.Thibodeaux BA, Caballero AR, Dajcs JJ, Marquart ME, Engel LS, O’Callaghan RJ. Pseudomonas aeruginosa protease IV: a corneal virulence factor of low immunogenicity. Ocul. Immunol. Inflamm. 2005;13: 169-82.
12.Girgis DO, Reed JM, Monds KS, Dajcs JJ, Marquart ME, O'Callaghan RJ. Pathogenesis of Staphylococcus in the rabbit anterior chamber. Invest. Ophthalmol. Vis. Sci. 2005; 46:1371-1378.
13.Marquart ME, Dajcs JJ, Caballero AR, Thibodeaux BA, O'Callaghan RJ. Calcium and magnesium enhance the production of Pseudomonas aeruginosa protease IV, a corneal virulence factor. Med. Microbiol. Immunol. 2005; 194:39-45.
14.Dajcs JJ, Thibodeaux BA, Marquart ME, Girgis DO, Traidej M, O'Callaghan RJ. Effectiveness of ciprofloxacin, levofloxacin, or moxifloxacin for treatment of experimental Staphylococcus keratitis. Antimicrob. Agents Chemother. 2004; 48:1948-1952.
15.Thibodeaux BA, Dajcs JJ, Caballero AR, Marquart M, Girgis DO, Callaghan RJ. Quantitative comparison of fluoroquinolone therapies of experimental Gram-negative bacterial keratitis. Curr. Eye Res. 2004; 28:337-342.
16.O’Callaghan, Girgis DO, Dajcs JJ, Sloop GD. Host defense against bacterial keratitis. Ocular Immunol. Inflamm. 2003;11: 171-181.
17.Dajcs JJ, Austin ME, Sloop GD, Moreau JM, Hume EBH, Thompson HW, McAleese FM, Foster TJ, O’Callaghan RJ. The corneal pathogenesis of Staphylococcus aureus strain Newman. Invest. Ophthalmol. Vis. Sci. 2002; 43:1109-1115.
18.Girgis DO, Dajcs JJ, O’Callaghan RJ. Phospholipase A2 activity of normal and Staphylococcus aureus-infected rabbit eyes. Invest. Ophthalmol. Vis. Sci. 2003; 44:197-202.
19.Dajcs JJ, Thibodeaux BA, Girgis DO, O'Callaghan RJ. Corneal pathogenesis of Staphylococcus aureus strain Newman. DNA Cell Biol. 2002; 21:375-382.
20.Moreau JM, Conerly LL, Hume EBH, Dajcs JJ, Girgis DO, Cannon BM, Stroman DW, O’Callaghan RJ. Effectiveness of mupirocin and polymixin B on experimental Staphylococcus aureus, Pseudomonas aeruginosa and Serratia marcescens keratitis. Curr. Eye Res. 2002; 21: 807-811.
21.Dajcs JJ, Thibodeaux BA, Girgis DO, Shaffer MD, Delvisco SM, O’Callaghan RJ. Immunity to lysostaphin and its therapeutic value for ocular MRSA infections in the rabbit. Invest. Ophthalmol. Vis. Sci. 2002; 43:3712-3716.
22.Moreau JM, Girgis DO, Hume EBH, Dajcs JJ, Austin MS, O’Callaghan RJ. Phospholipase A2 in rabbit tears: a host defense against Staphylococcus aureus. Invest. Ophthalmol. Vis. Sci. 2001; 42:2347-2354.
23.Dajcs JJ, Thibodeaux BA, Hume EBH, Zheng XD, Sloop GD, O'Callaghan RJ. Lysostaphin is effective in treating methicillin-resistant Staphylococcus aureus endophthalmitis in the rabbit. Curr. Eye Res. 2001; 22:451-457.
24.Dajcs JJ, Moreau JM, Thibodeaux BA, Traidej M, Austin MS, Marquart ME, O’Callaghan RJ. The effectiveness of ciprofloxacin or ofloxacin in a prophylaxis model of Staphylococcus keratitis. Cornea. 2001; 20:878-880.
25.Hume EBH, Dajcs JJ, Moreau JM, Sloop GD, Wilcox MDP, O’Callaghan RJ. Staphylococcus corneal virulence in a new topical model of infection. Invest. Ophthalmol. Vis. Sci. 2001; 42:2904-2908.
26.Dajcs JJ, Moreau JM, Stroman DW, Schlech BA, Ke TL, Thibodeaux BA, Girgis DO, Caballero AR, and O'Callaghan RJ. The effectiveness of tobramycin or Ocuflox therapy in a prophylaxis model of Staphylococcus keratitis. Curr. Eye Res. 2001; 23: 60-63.
27.Dajcs JJ, Hume EBH, Moreau JM, Caballero AR, Cannon BM, O'Callaghan RJ. Lysostaphin treatment of methicillin-resistant Staphylococcus aureus keratitis in the rabbit. Invest. Ophthalmol. Vis. Sci. 2000; 41: 1432-1437.
28.Hume EBH, Dajcs JJ, Moreau JM, O'Callaghan RJ. Immunization with alpha-toxin toxoid protects the cornea against tissue damage during experimental Staphylococcus aureus keratitis. Infect. Immun.2000; 68: 6052-6055.
29.Sloop GD, Moreau JM, Conerly LL, Dajcs JJ, O’Callaghan RJ. Acute inflammation of the eyelid and cornea in Staphylococcus keratitis in the rabbit. Invest. Ophthalmol. Vis. Sci. 1999; 40: 385-391.
30.Hume EBH, Moreau JM, Conerly LL, Cannon BM, Dajcs JJ, Hill JM, O’Callaghan RJ. Clarithromycin for experimental Staphylococcus aureus keratitis. Curr. Eye Res. 1999; 18: 358-362.
31.Hazlett LD, McCellan SM, Hume EBH, Dajcs JJ, O’Callaghan RJ, Wilcox MDP. Extended wear contact lens usage induces Langerhans cell migration into the cornea. Exp. Eye Res. 1999; 69: 575-577.
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