Sirshendu Ghosh

Aseptic & Sterility Assurance Microbiologist | Annex 1 CCS | cGMP Compliance

CAMember since September 24, 2023

Industrial MicrobiologistSterility Assurance and QC MicrobiologyAnnex 1 and Contamination Control Strategy (CCS) implementationEnvironmental Monitoring (EM) analysis & TrendingAseptic Processing / APS ProgramsMethod Validation & SuitabilityQMS (OOS, OOT, CC, CAPA, Deviations)US FDA, ISO 14644, EMA, Health Canada regulationsUSP / EP compendial methodsLead auditor and GAP analysis, Lead Investigator (RCA)Cleanroom / Gown QualificationsMedia FillSOP/Protocol/Policy DevelopmentAseptic processingMicrobiologyEM monitoringCAPARoot Cause AnalysisMethod validationBioburden testingPyrogen/Endotoxin testingEU Annex 1FDA CFR 211USPGMP reportingGAP analysisLIMSQMS

About

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.

Experience

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