Senior Project Manager, CSP Applications Development

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 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.

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.

Nearest Major Market: Auburn

Nearest Secondary Market: Opelika