Senior Project Manager, CSP Applications Development

Responsibilities Include 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 standards •    Act as a customer-facing representative for platform technologies, including participation in industry trade shows and technical discussions •    Collaborate 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 development •    Assist 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 guidance •    Work 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 met •    Conduct appropriate project risk assessments and define a mitigation plan •    Develop approaches to sustain and communicate success and progress across global stakeholders •    Support 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 solutions •    Work with intellectual property counsel to submit IP invention disclosure and ensure all data and drawings are provided for provisional applications •    Participate in monthly Project Phase Reviews and provide updates to assigned projects along with status update on current phase •    Runs concurrent projects effectively •    Other duties as assigned Qualifications/Education/Special Skills Education •    BS Degree in Engineering field (Chemical, Electrical, Mechanical, Biomedical, or related field) required. •    PMP (Project Management Professional) certification strongly preferred. Experience •    5-7 years of leading product development and project/program management experience within the Medical Device or Pharmaceutical industry •    Proven experience managing cross-functional teams and customer-facing projects. •    Experience with IND, NDA, NDA 505(b)2, and ANDA drug development preferred •    Familiarity 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 reports Technical Skills •    Strong 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 & Tools •    Excellent 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.

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