Sam Saeidi Email & Phone Number

Cambridge, Ontario, Canada

Technical Leadership in Pharmaceutical Formulation Development (Injectables)• Lead formulation development for injectable products, specializing in cartridge and pre-filled syringes (PFS) within the Pharmaceutical Development (PD) team.• Expertise in product characterization, formulation optimization, surface compatibility, container-closure compatibility, and stability testing for injectable drug products.• Conducted comprehensive stress studies, filter compatibility, and… Show more Technical Leadership in Pharmaceutical Formulation Development (Injectables)• Lead formulation development for injectable products, specializing in cartridge and pre-filled syringes (PFS) within the Pharmaceutical Development (PD) team.• Expertise in product characterization, formulation optimization, surface compatibility, container-closure compatibility, and stability testing for injectable drug products.• Conducted comprehensive stress studies, filter compatibility, and container-closure integrity (CCIT) assessments to ensure product stability and performance.Advanced Formulation of Complex Injectable Systems• Developed and optimized complex injectable formulations for a range of drug types, including:o Small molecule actives with high oxygen sensitivity, incorporating gassing and off-gassing using inert gases.o Peptide formulations prone to agglomeration and stability issueso Lipid Nanoparticles (LNPs) for novel drug delivery systems.o High organic solvent formulations for specialized drug products.Tech Transfer, Scale-Up, and GMP Manufacturing Leadership• Successfully led technology transfer and scale-up of complex formulations from development to GMP manufacturing, ensuring seamless production.• Oversaw the manufacturing and filling processes for injectable products in compliance with GMP standards, ensuring product quality and consistency.Subject Matter Expert (SME) in Formulation Troubleshooting and Optimization• Acted as an SME for troubleshooting and optimizing existing formulations, driving improvements in product performance and manufacturing efficiency. Show less

- Developed innovative fast-disintegrating, immediate-release tablet formulations for highly lipophilic actives (log p >5), utilizing Self-nanoemulsifying Drug Delivery System (SNEDDS) with a high oil content (not less than 10%).- Expertly formulated liquid-fill hard-gel capsule formulations employing SNEDDS technology, and successfully created lab-scale prototypes for advanced evaluation.- Optimized SNEDDS formulations to enhance bioavailability and lymphatic transport, leveraging… Show more - Developed innovative fast-disintegrating, immediate-release tablet formulations for highly lipophilic actives (log p >5), utilizing Self-nanoemulsifying Drug Delivery System (SNEDDS) with a high oil content (not less than 10%).- Expertly formulated liquid-fill hard-gel capsule formulations employing SNEDDS technology, and successfully created lab-scale prototypes for advanced evaluation.- Optimized SNEDDS formulations to enhance bioavailability and lymphatic transport, leveraging analytical data including dissolution, emulsion particle size (PID), and lipolysis.- Prepared lab-scale tablet prototypes using a manual handpress and conducted comprehensive analytical testing to characterize the tablets fully, assessing parameters such as hardness, friability, Loss on Drying (LOD), disintegration, and dissolution.- Executed five submission and clinical batches at 15-25 kg scale in a Good Manufacturing Practice (GMP) environment, performing tasks such as material weighing and dispensing, assembly and operation of manufacturing equipment (V-blender, high-shear granulator, and fluid-bed dryer), and cleaning of equipment and rooms.- Authored technical documents including stability and dissolution protocols, master manufacturing batch records, and technical reports, encompassing product development reports, Quality Overall Summary (QOS), and stability trends.- Collaborated effectively in identifying and resolving manufacturing issues related to formulation, demonstrating strong problem-solving skills.- Actively participated in Corrective and Preventive Action (CAPA) and Out Of Specification (OOS) investigations, contributing to quality assurance and regulatory compliance. Show less

Toronto, Ontario, Canada

○ Helped pharmaceutical clients within Canada in product development, excipient selection and formulation challenges of different dosages forms including tablets, capsules, oral liquids and topicals.○ Initiated and developed new opportunities within the Pharmaceutical Industry, primarily working with R&Ds and B2B development teams. ○ Consulted Canadian licensed producers on the development of cannabinoid formulations○ Provided internal and external technical trainings about… Show more ○ Helped pharmaceutical clients within Canada in product development, excipient selection and formulation challenges of different dosages forms including tablets, capsules, oral liquids and topicals.○ Initiated and developed new opportunities within the Pharmaceutical Industry, primarily working with R&Ds and B2B development teams. ○ Consulted Canadian licensed producers on the development of cannabinoid formulations○ Provided internal and external technical trainings about product lines, excipients and pharmaceutical formulations○ Cooperated closely with sales teams to support new and existing pharmaceutical customers○ Actively prospected for new businesses to grow the territory and communicated with other internal business units to support lead generation○ Collaborated with Univar Global marketing team to create strategic marketing campaigns and materials○ Kept track of leads, opportunities and team activities through Salesforce. Show less

Toronto, Canada Area

Part of pharma team.Responsible for new business development at R&D level.

Canada

• Developed formulas for liquid and semi-solid dosage forms • Prepared lab batches to optimize formulations and collect informal stability data • Designed manufacturing processes, supervised scale-up and wrote MBRs• Coordinated with the team leader and R&D analysts to do projects on timely manner• Interacted with suppliers to obtain materials and maintained knowledge of new excipients • Documented and reported results per established SOP’s and in compliance with cGMP•… Show more • Developed formulas for liquid and semi-solid dosage forms • Prepared lab batches to optimize formulations and collect informal stability data • Designed manufacturing processes, supervised scale-up and wrote MBRs• Coordinated with the team leader and R&D analysts to do projects on timely manner• Interacted with suppliers to obtain materials and maintained knowledge of new excipients • Documented and reported results per established SOP’s and in compliance with cGMP• Issued CAPAs and deviation assessments • Coordinated with QA, QC, production and validation teams to do scale-up /commercial batches of developed formulas • Performed duties in compliance with the applicable SOP’s, cGMP and Safe Work Practices (SWP) Show less

Mcmaster University

• Synthesized air and moisture sensitive germanium precursors • Used GC-MS, UV, 1H NMR and 13C NMR for characterization of products• Purified the synthesized precursor using distillation, recrystallization and column chromatography techniques • Studied kinetic characteristics of reactive materials by laser flash photolysis• Taught first and second year organic chemistry through tutorials and help centres• Supervised, managed and kept track of student’s performance in… Show more • Synthesized air and moisture sensitive germanium precursors • Used GC-MS, UV, 1H NMR and 13C NMR for characterization of products• Purified the synthesized precursor using distillation, recrystallization and column chromatography techniques • Studied kinetic characteristics of reactive materials by laser flash photolysis• Taught first and second year organic chemistry through tutorials and help centres• Supervised, managed and kept track of student’s performance in chemistry labs• Wrote scientific reports, presented and defended research results • Obtained Lab safety and WHIMS certificate Show less

Tehran, Iran

• Designed and performed synthesis of organic compounds and method development• Synthesized solid acids and tested them in the synthesis of some pharmaceutical starting materials • Made biocatalyst by Immobilization (Baker’s yeast) on the surface of silica • Tested green-chemistry protocols in the synthesis of pharmaceutical precursors• Wrote technical reports and presented results at conferences

Dip. Pharm. R&D Pharmaceutical, Pharmaceutical Formulation And R&D

• Obtained knowledge of laws and regulations related to pharmaceutical industry in north America including Canadian law (food and drugs.

Master'S Degree, Organic / Analytical Chemistry, A-

Master’s Thesis Project • Measured the kinetic and thermodynamic parameters of the reactions of some germanium compounds using laser flash.