Lead the new product launches, supply planning and distribution and logistics activities and team located in Canada.

Oversee 3PL warehouse operations (inbound, storage, inventory reconciliation, outbound, returns, destruction) for on-time shipment, on-time delivery and customer experience for pharmaceutical and aesthetic products distributed to Canadian customers.

• Review KPIs and Metrics with third party warehouse and third-party distribution centers for the the contractual requirements are met and implement new projects by providing technical requirements and project management framework/skills.• Lead evaluations and RFI/RFP involving Third Party Packagers, Third Party Logistics providers to improve overall supply chain (i.e. overlabeling, rework, distribution network alignment and optimization, etc).• Lead monthly and quarterly business… Show more • Review KPIs and Metrics with third party warehouse and third-party distribution centers for the the contractual requirements are met and implement new projects by providing technical requirements and project management framework/skills.• Lead evaluations and RFI/RFP involving Third Party Packagers, Third Party Logistics providers to improve overall supply chain (i.e. overlabeling, rework, distribution network alignment and optimization, etc).• Lead monthly and quarterly business reviews with Canadian 3rd party logistics providers.• Support business with process mapping for different functional areas to innovate lean processes internally and externally.• Review, dispute and approve launch and logistics invoices and monthly/yearly spending/budget (>$10M) and accruals based contractual agreements.• Participate in QA audits as Operations, Launch Excellence and Logistics SME when required.• Build and maintain databases as needed to streamline procurement, Inventory management, distribution complaints, KPIs and trending reports. Follow up with action plan with the distribution centers and internal stakeholders depending on the findings.• Develop and drive the execution of project plans and timelines with cross-functional, local, global, internal and external stakeholders and ensure timelines are met or revised and escalated to country or global head as needed.• Lead projects related to new product launches, changes to products/packaging, changes in manufacturing/packaging sites, product discontinuations, transitions, 3PL continuous improvements and any other supply chain and logistics related project.• Participate in QA audits as Operations, Launch Excellence and Logistics SME when required.• Oversee the distribution centers to ensure customer needs are met.etc. Show less

• Coordinate projects related to product launches, changes to products/packaging, changes in manufacturing/packaging sites from a product supply standpoint and product discontinuation. • Facilitate cross functional discussions to resolve issues and identify root cause and corrective actions.• Develop project plans and ensure plan is properly communicated and executed with cross functional team members.• Follow up with cross functional team members to ensure that projects progress… Show more • Coordinate projects related to product launches, changes to products/packaging, changes in manufacturing/packaging sites from a product supply standpoint and product discontinuation. • Facilitate cross functional discussions to resolve issues and identify root cause and corrective actions.• Develop project plans and ensure plan is properly communicated and executed with cross functional team members.• Follow up with cross functional team members to ensure that projects progress according to plan.• Identify and raise potential issues that could impact overall project implementation or product supply.• Assist in technical evaluations involving Third Party Packagers, Third Party Logistic to improve overall supply chain (i.e. importing frozen product, overlabeling, rework etc).• Interface with third party packagers, third party laboratories and third party logistic providers to implement new projects by providing technical requirements and project management framework/skills.• Facilitate the use of the Global Launch Excellence tool with Brand Team members for new product launches.• Update New Product Introduction and Launch Excellence databases (and any other database) with accurate information.• Develop technical justifications and provide technical support to Regulatory, QA, Commercial and Medical teams when required.• Lead monthly Launch Excellence meeting to ensure all cross functional team members are aware of project progress, issues, and potential delays.• Participate in QA audits as Operations SME when required.• Support and ensure compliance to Federal Environmental Regulations including Chemical Management Plan and New Substance Notification Requirements.• Support special projects related to Technical Operations, QA, Regulatory or Commercial areas of the business as requested by Management.• Support Logistics to review 3P Logistics storage, transactional, accessorial and freight invoices and SOPs and maintain financial database and records. Show less

• Monitor close to 200 sites across the US and Canada for CPT blood collection and other type of samples.• Responsible to write/review and approve Clinical Laboratory Manuals• Responsible to write/review and approve Sample Reception SOP/CSP• Organize and drive decisions on clinical sample collection for healthy and disease subjects (oncology, infectious (HIV), etc.) and shipping schedule for Phase 1-IV studies;• Coordinate clinical sites, couriers and clients to monitor the… Show more • Monitor close to 200 sites across the US and Canada for CPT blood collection and other type of samples.• Responsible to write/review and approve Clinical Laboratory Manuals• Responsible to write/review and approve Sample Reception SOP/CSP• Organize and drive decisions on clinical sample collection for healthy and disease subjects (oncology, infectious (HIV), etc.) and shipping schedule for Phase 1-IV studies;• Coordinate clinical sites, couriers and clients to monitor the shipment and delivery of clinical study samples in a timely manner; • Review consent forms.• Accountable for ensuring suitable sample handling training are provided for the clinical study in accordance to the Clinical Protocol and Laboratory Manual;• Responsible for monitoring effectiveness of clinical site sample handling training and quality of documentation and samples received;• Responsible for ensuring sample collection information is adequate for effective sample tracking and reconciliation;• Verify that clinical sites and/or CROs send samples according to agreed stability shipping schedule for the study and take corrective action where this is not the case;• Ensure samples are shipped to ImmuneCarta according to the agreed schedule for the study;• Maintain professional knowledge of current GCP/GLP, biobanking, Clinical Trials, and sample management policies and best practices and ethical guidelines and apply knowledge appropriately;• File, track and review all related documentation in a timely manner in accordance to study milestones and budget.• Responsible for maintaining sample shipment and result databases and statistics• Participate in Kick-Off meetings for Phase I-IV clinical studies Show less

•In depth hands on experience to design, develop, troubleshoot and oversee Ligand Binding Assays (LBA’s using ELISA, Chumilescence, Mesoscale, Hybridization) and Capillary Electrophoresis / Laser-Induced Capillary Electrophoresis methods •In depth knowledge of oligonucleotides and metabolite analysis.•Participate in Kick-Off meetings for Phase I-IV clinical studies•Review Clinical Protocols•Write and review Lab Manuals (PK/ADA)•Serve as primary point of contact for Clinical… Show more •In depth hands on experience to design, develop, troubleshoot and oversee Ligand Binding Assays (LBA’s using ELISA, Chumilescence, Mesoscale, Hybridization) and Capillary Electrophoresis / Laser-Induced Capillary Electrophoresis methods •In depth knowledge of oligonucleotides and metabolite analysis.•Participate in Kick-Off meetings for Phase I-IV clinical studies•Review Clinical Protocols•Write and review Lab Manuals (PK/ADA)•Serve as primary point of contact for Clinical Managers in resolving clinical study PK/ADA sample discrepancies and for Sponsors in resolving quality and scientific issues.•Generate and review Study Plans and Reports for preclinical and clinical BA studies.•Participate in improving scientific and regulatory processes via update/creation of SOP's, and development of best practices for Bioanalysis.•Participate in internal and external audits providing required information to auditors as needed and respond to internal audit findings on assigned preclinical and clinical studies.•GLP Expertise in conducting preclinical and clinical studies in a regulated environment.•Profound knowledge of OECDs, EMAs, and ICH-GCPs Guidance.•Ensure that studies are completed within the allocated budget and tight timelines.•Instruct and guide a team of ten analysts in the daily task implicated to generate bioanalytical data.•Review and approve BA raw data and reports to ensure quality and compliance.•Excellent communication skills with the multiple parties involved in clinical and preclinical studies.•High organization skills to tackle a multitude of different studies in extremely tight timelines.•Close relationship with clinical sites for sample reconciliation in RAVE.•Close relationship with clients; timely communication.•Issue detailed reports ready for IND submissions; start-up of the SEND initiative.SoftMaxPro, Watson, Statlia, SAP, etc.liquid/liquid and solid phase extractions, ELISA, CE, HPLC, LC-MS, etc. Show less

Liquid-Liquid Extractions; Solid Phase Extraction; ELISA; Hybridization Based ELISA; LCMS; Laser-Induced CE; CE; Tissue homogenization and extraction; Instrument and Pipet calibration using Artel; HPLC; GC; Watson Lims; Statlia; SoftMaxPro;

•Dispatch Controlled Temperature loads: Reefers, Vented vans and Specialities.•Communicate with clients to organize and set up new runs; •Direct negotiation with drivers, owner operators and clients; •Fuel tax filling; •Log book review; •Complete paperwork filling