Associate Project Management

Job Details:Duration: 12 months contractDescription: The Contract Development and Manufacturing (ACDM) organization is seeking a highly qualified candidate to support synthetic-related outsourcing associated with execution of external development, commercial and clinical supply of drug substance (DS).The position will be focused on synthetic small molecule drug substance/process chemistry and serve as a key enabling role in a high-performing cross-functional organization.Individual projects may span development, sourcing (e.g., requests for proposal and site selection), supplier onboarding, manufacturing, and continuous improvement activities for both non-GMP and GMP commercial / clinical deliverables.The Contract Development and Manufacturing team develops and implements the external sourcing strategy for Company's portfolio from early phase through commercial delivery.This role will support engagement and oversight of Company's Contract Development and Manufacturing sites through executing activities according to Good Manufacturing Practices (cGMP) principles and the ACDM business practices.Job Responsibilities: Day-to-day oversight for external synthetic/process chemistry-related projects:Overseeing and supporting ongoing activities at selected sites along with any subcontracted sites to ensure project deliverables, including compliance, timelines, product quality, and costWorking closely with the ACDM team, Process Development, External Quality, Supply Chain, and other internal stakeholders to support sourcing activities, including managing scope of work (SoW) and quotation request documentsCoordinating requests for shipment of materials/samples between sitesManaging purchase orders, invoices, and project-related budgetOverseeing deviations investigations and change managements as neededMaintain and update business related trackers as neededSupport continuous improvement projects and operational excellence within ACDMPerforming other related duties and tasks as necessary or as assignedBasic Qualifications: Bachelor's Degree in Engineering, Chemistry, or Science-related field4+ years of Manufacturing or Operations experiencePreferred Qualifications: Knowledge of synthetic drug development and manufactureExperience in Project ManagementUnderstanding of cGMP, Operations and Regulatory/CMC policies and requirements, especially in the Pharmaceutical IndustryExperience with interfacing and managing CRO and CDMO relationshipsExperience with change management, deviation investigations and implementation of corrective/preventive actionsUnderstanding of tech transfer, drug development and commercialization of synthetic therapeuticsExperience working in cross-functional settings, as part of cross-functional team or matrix teamStrong interpersonal relationship and communication skills both written and verbalBasic Qualifications: Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experienceTop Must Have Skill Sets: Chemistry related industry/environment experiencesKnowledge of synthetic drug development and manufactureExperience in Project ManagementUnderstanding of cGMP, Operations and Regulatory/CMC policies and requirements, especially in the Pharmaceutical IndustryDay to Day Responsibilities: Day-to-day oversight for external synthetic/process chemistry-related projects:Overseeing and supporting ongoing activities at selected sites along with any subcontracted sites to ensure project deliverables, including compliance, timelines, product quality, and costWorking closely with the ACDM team, Process Development, External Quality, Supply Chain, and other internal stakeholders to support sourcing activities, including managing scope of work (SoW) and quotation request documentsCoordinating requests for shipment of materials/samples between sitesManaging purchase orders, invoices, and project-related budgetOverseeing deviations investigations and change managements as neededMaintain and update business related trackers as neededSupport continuous improvement projects and operational excellence within ACDMPerforming other related duties and tasks as necessary or as assignedAbout US Tech Solutions:US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com."US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"