Irfaan Hafeez Email & Phone Number

Vancouver, Bc, Ca

Vancouver, British Columbia, Canada

Report to the VP of Supply Chain, oversee and execute on all activities related to the management of IMP and NIMP for all Phase I - III studies (APAC, EMEA, NA, LAM).Global import/export expertise in distribution of Biologics across 32 countries. Key areas: China, South Korea, Japan, Chile, Brazil, Argentina, Ukraine, AfricaManaged vendor RFPs, SOW design, packaging, labeling, and distribution strategies for 12 global clinical protocols in the antibody space including the supply design of two PH III studies, covering 32 countries. Ensured uninterrupted supply and met all Clinical FPI deadlines.Well versed in the negotiation and review of supply related contract language, Quality Technical Agreements, IMPDs, Pharmacy manuals, Supply agreements, MSA’s, and RFPs. Knowledge expert in key areas of global trade compliance for biologics (USFWS, USDA, FDA, CFIA, CBSA, EU Directives, CITES). Expertise and strategic use of incoterms 2020, IoR responsibilities, customs documentation development, TDG compliance, VAT and GST recovery, cold chain packaging strategies, and courier selection.Key achievements:• Managed staff of 10 (Procurement, Manufacturing, Clinical, and R&D logistics) in Vancouver & Seattle -100% retention over 5 yrs.• Initiated a drug supply strategy with Pfizer for PHII combo therapy saving millions in upfront cost commitment, and significantly de-risked the complex early-stage study.• Implemented ‘direct to clinical site’ distribution (Myoderm CTRx), saved 1.2 million in upfront drug costs, reduced lead-time to patient treatment from 4 months to 48 hours. • Introduced and managed Zymeworks Procurement Policy, and redesigned the procurement workflow in Netsuite ERP in compliance with SOX reducing problem POs from 30% to 1%.• Procured 3 million dollars of equipment, relocated all lab equipment/inventory to new permanent locations in Vancouver and Seattle labs on time and under budget.• Designed R&D central stores warehouse inventory room.

Vancouver, Canada Area

Reporting to the director of Manufacturing managed all clinical supply activities related to Investigational Oncology drug products and ancillary supplies for two Phase III studies and six Phase II studies (APAC, EMEA, NA). This included preparing supply RFPs; vendor selection; SOW negotiation and development; providing drug forecasts including under Blinded status; budget forecasts; batch record review; procurement of combo therapy and ancillary supplies; collaboration on Quality Technical Agreements; Pharmacy manual contribution; and IMPD submissions.For each clinical study and in close coordination with Clinical, Quality, Regulatory, and Finance, provided UAT for the IRT, managed label design, packaging, labeling, distribution, return, reconciliation, and destruction activities of all supplies at global depots under GxP quality and regulatory requirements.Developed local sourcing strategies and saved 30% inventory overage and reduced the lead-time from 4 months to 24 hour delivery. Developed GMP reverse logistics protocols to recover and reuse supply in the clinic saving 30% overage and high cost of packaging, labeling and shipping resupply. Implemented pooled drug strategies for USA studies using label on demand SOWs to micromanage drug product across multiple protocols.Supported Clinical Operations through weekly meetings on supply forecasting, IXRS supply strategies, pharmacy manual contribution, and temperature oversight. Prepared customs documents and declarations for global import/export of Investigational supplies, drug product, API and samples (China, EU, APAC, NA)Implemented a UK VAT recovery strategy, applied for a UK VAT number, filed quarterly returns and monthly Intrastat for Finance (20% savings).Key contributor to the development of a Drug Supply Management Forecasting System using Tableau software. Implemented forecasting calculations, and oversaw the design of dynamic Tableau dashboard reports.

Under direction of the Senior Clinical Supplies Manager and Senior Supply Chain Manager, coordinated the packaging and labeling activities of investigational drug product for Oncology and Occular studies in USA, Canada and EU. • Proficient in label design, label printing, and labeling of drug as well as preparing kits• Forecasted clinical supply by factoring damage, site expansion, and enrollment shift• Reconciled accountability logs with Clinical and Quality groups• Expedited the receipt and delivery of all clinical supplies using SAP ERP• Developed SAP Web-based automated workflow for return drug and devices• Managed and reconciled inventory movements and usage decisions in SAP

Trained in GCP’s and achieved role of Clinical Trial Supplies Backup. Specialized in labeling investigational drug, label design, accountability log reconciliation, preparing customs documentation, drug packaging validation design.Supported Pilot Manufacturing, processed inventory movements in SAP for accurate resupply and batch record accountability, ensured proper GMP receipt and quarantine of materials, and analyzed inventory discrepancies. Proficient in quality systems such as deviations, investigations, CAPA and change control: initiated reports, worked with QA, and liaised with cross-functional departments. Assumed leadership roles in all departmental responsibilities and worked closely with QA, QC, Clinical, CMC, Finance and Procurement in the efficient movement and storage of materials using GMP quality systems.

Bachelor Of Music, Music Theory And Composition

Bachelors degree and Graduate studies in Composition

Diploma, New Media

Web design, digital print, film and 3D animation.