Senior Project Manager, Csp Applications Development, Auburn

Senior Project Manager, CSP Applications Development
Responsibilities
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 **** and ISO ***** 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 **** and ISO ***** 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 ***** 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.
Nearest Major Market:
Auburn
Nearest Secondary Market:
Opelika
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