P. Joseph Mazarin Fidelis
Manager Analytical Department @Orbicular Pharmaceutical Technologies
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WORK HISTORY
Manager Analytical Department @Orbicular Pharmaceutical Technologies
Kukatpally, IN
Key Responsibilities:Lead two specialized teams: Analytical Method Development & Validation and Formulation Characterization.Manage analytical activities for tech transfer, scale-up, and regulatory submission of various dosage forms.Review and finalize specifications (STPs) and technical documents aligned with US FDA and MHRA standards.Author and implement SOPs ensuring data integrity, GLP/GMP compliance, and audit preparedness.Design systems to track sample load, prioritize critical projects, and optimize analytical throughput.Key Achievements:Resolved 10+ complex analytical challenges, improving method robustness and reproducibility.Authored and approved 50+ SOPs, improving internal QA and external audit outcomes.Developed a custom performance tracking system to enhance lab productivity and documentation accuracy.Played a key role in reducing audit findings by over 10%, contributing to successful compliance inspections.Mentored junior and mid-level scientists in QbD principles, regulatory expectations, and method troubleshooting.
EDUCATION
Carmel Hr. Sec. School, Nagercoil
+2
FATHIMA COLLEGE OF PHARMACY (Inst. Code - 077), KADAYANALLUR, TIRUNELVELI
Bachelor of Pharmacy - BPharm, Pharmacy
C.L.Baid Metha College of Pharmacy (Affilated to Dr. MGR medical university Chennai)
M.Pharm, Pharmaceutical Analysis
C.L.BAID METHA COLLEGE OF PHARMACY (Inst. Code - 027), CHENNAI
Master's degree, Pharmaceutical Analysis
ABOUT P. JOSEPH MAZARIN FIDELIS
I’m a Senior Analytical R&D Leader with over 20 years of experience in method development, validation, and regulatory compliance across global markets including US FDA, MHRA, WHO, ANVISA, and PMDA (Japan).My expertise spans the development and optimization of analytical methods for a wide range of dosage forms, ensuring global submission-readiness and alignment with ICH, GLP, and cGMP guidelines. I’ve contributed validated data to 10+ ANDA submissions, designed 50+ SOPs, and led high-performing teams that support robust, audit-ready lab systems.Currently leading analytical and formulation characterization teams at Orbicular Pharmaceutical Technologies, I specialize in solving complex analytical challenges, driving regulatory excellence, and mentoring scientists to grow into future leaders.I am passionate about bridging science and regulatory strategy—delivering data integrity, innovation, and speed to market.Key Areas:HPLC | GC | Dissolution | Formulation characterization studies |Stability Studies | SOP Design | Analytical Tech Transfer | Regulatory CMC | Audit Readiness | Team Leadership
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