Senior Project Manager, CSP Applications Development

ResponsibilitiesInclude but are not limited to the following:Define, create and communicate a commercialization path for new medical devices or pharmaceutical product solutions from concept creation through product development.Create documentation to define system requirements and specifications, managing internal and external stakeholders, through development, validation, documentation and release of products.Leads cross-functional project execution for platform technologies, ensuring compliance with ISO 9001 and ISO 13485 standardsAct as a customer-facing representative for platform technologies, including participation in industry trade shows and technical discussionsCollaborate with internal stakeholders including R&D, Regulatory, and site teams to ensure successful delivery of services related to pre-clinical to Phase II within oral solid dose drug developmentAssist in North America product sustainability as a technical lead, coordinating Operations, R&D, and Regulatory Teams for product recyclability initiatives to align with regulatory critical guidanceWork with a multi-disciplinary product development team and cross business unit to develop, evaluate, document, and introduce new products.Review all designs and validations to ensure all specifications are being metConduct appropriate project risk assessments and define a mitigation planDevelop approaches to sustain and communicate success and progress across global stakeholdersSupport sales efforts in the bid process to gain repeat, and/or new, long-term business as needed.Partners with Industrial Designers to incorporate sponsor user requirement specifications to create innovative solutionsWork with intellectual property counsel to submit IP invention disclosure and ensure all data and drawings are provided for provisional applicationsParticipate in monthly Project Phase Reviews and provide updates to assigned projects along with status update on current phaseRuns concurrent projects effectivelyOther duties as assignedQualifications/Education/Special SkillsEducation* BS Degree in Engineering field (Chemical, Electrical, Mechanical, Biomedical, or related field) required.* PMP (Project Management Professional) certification strongly preferred.Experience5-7 years of leading product development and project/program management experience within the Medical Device or Pharmaceutical industryProven experience managing cross-functional teams and customer-facing projects.Experience with IND, NDA, NDA 505(b)2, and ANDA drug development preferredFamiliarity with ISO 9001 and ISO 13485 quality management systems and regulatory standards.Experience with design verification, validation, and documentation processes.Demonstrated success in mentoring and performance management of direct reportsTechnical SkillsStrong working knowledge of design controls and regulatory requirements (US, EU, Japan, China).Proficiency in ICH-GCP/ISO 14155 and clinical research regulatory frameworks.Skilled in documentation, testing, and design-control procedures.Proficiency in statistical and analytical tools, including design of experiments (DOE).Broad knowledge of polymeric materials and processing techniques (extrusion, injection molding, thermoforming) preferred.Familiarity with sustainability and recyclability initiatives in product development.Soft Skills & ToolsExcellent written and verbal communication skills; able to present to stakeholders at all levels.Strong organizational and time management skills; capable of managing concurrent projects.Ability to work independently and collaboratively in a virtual or cross-site environment.Proficiency in Microsoft Office Suite (Project, Excel, Word, PowerPoint).Ability to interface effectively with Sales, R&D, Regulatory, and Operations teams.