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.