Sirshendu Ghosh

Award-winning ISO 13485:2016 Lead Auditor Certified Microbiologist with 6+ years leading sterility assurance and microbiology programs across sterile and radiopharmaceutical manufacturing in the USA and Canada. Expert in Annex 1 CCS, aseptic processing, EM, validation, and FDA/Health Canada/USP/EP compliance.

ASEPTIC SPECIALIST MICROBIOLOGIST - Perspective Therapeutics USA - USA

(2025-02)

Lead the microbiology team and cross functional support for sterile drug manufacturing operations.

• Designed new sterile manufacturing sites per EU Annex 1/FDA guidelines, leading CCS, EM, APS/Media Fill, EMPQ, and ISO cleanroom qualification programs
• Drove QMS activities including QRMs, CAPAs, Deviations, and Change Controls; developed company-wide microbiology SOPs covering CCS, OOS/OOT, and Cleaning Validation
• Led microbiological method validation and suitability studies; delivered cGMP and aseptic processing training across cross-functional departments

LEAD MICROBIOLOGIST - Nucleus RadioPharma USA - USA

(2024-04 - 2025-02)

Supervised microbiology laboratory operations supporting commercial radiopharmaceutical manufacturing.

• Authored SOPs, test methods, validation protocols, and URSs supporting sterile radiopharmaceutical manufacturing under FDA and Health Canada regulations
• Performed Sterility, Bioburden, and microbiological testing of radioactive drug products, intermediates, and raw materials in a cGMP environment
• Managed laboratory budgets, equipment procurement, and personnel development while driving continuous improvement and operational excellence

STERILITY ASSURANCE MICROBIOLOGIST - AtomVie Global RadioPharma (CPDC) - Canada

(2021-07 - 2024-04)

Served as Lead Investigator for microbiology-related deviations, excursions, investigations, and Out-of-Specification (OOS) events.

• Served as SME for internal GMP audits and Health Canada regulatory inspections; implemented CCS-aligned microbial isolate programs supporting GPT initiatives
• Led aseptic gowning, cleanroom behavior, GDP, and microbiological technique training programs for all GMP facility personnel and new hires
• Managed equipment qualification, calibration, and preventive maintenance; designed comparison studies delivering cost reductions and process improvements

MICROBIOLOGIST - Septodont Novocol Pharma of Canada - Canada

(2020-10 - 2021-07)

• Executed EM, Sterility, Bioburden, and Endotoxin testing in classified cleanrooms; investigated OOS deviations and authored trend reports within LIMS

QC LAB TECHNICIAN - ThermoFisher Scientific Canada - Canada

(2020-06 - 2020-10)

Supported GMP laboratory operations through calibration, maintenance, media preparation, documentation, and laboratory compliance.

• Supported QC laboratory operations at a cGMP site, maintaining GLP documentation, reagent inventory, equipment maintenance, and regulatory-compliant waste disposal

Customer Service Manager - Walmart Canada - Canada

(2018-11 - 2020-05)

Led and coached a team of 7 associates across customer service, front-end operations, and cash management.

• Led a team of 11 associates across store operations; recognized annually for leadership excellence, customer satisfaction performance, and scheduling optimization

Advanced Diploma - Industrial Biotechnology (Microbiology) - Centennial College (2020)

Master of Science (MSc) - Biotechnology - Northumbria University (2016)

Bachelor of Science (Honours) - Microbiology - University of Calcutta (2015)