Senior Project Manager, CSP Applications Development

Aptar Italia S.P.A.; Auburn (AL); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading global medical device company seeks a Senior Project Manager for CSP Applications Development. This role involves defining commercialization paths for new medical devices and managing cross-functional projects while ensuring compliance with regulatory standards. Ideal candidates will possess a degree in Engineering and PMP certification, with 5-7 years in the medical device or pharmaceutical sector. Strong communication skills and experience with design verification and project management are crucial.

Qualifications

• 5-7 years of experience in product development and project management in the Medical Device or Pharmaceutical industry.
• Experience managing cross-functional teams.
• Familiarity with IND, NDA, NDA 505(b)2, and ANDA drug development.

Responsibilities

• Lead the commercialization path for medical devices from concept to development.
• Create documentation for system requirements and manage stakeholders.
• Ensure compliance with ISO 9001 and ISO 13485 standards.

Skills

Design controls and regulatory requirements

Documentation and design-control procedures

Statistical and analytical tools

Excellent written and verbal communication skills

Strong organizational and time management skills

Ability to work independently and collaboratively

Education

BS Degree in Engineering field

PMP certification

Tools

Microsoft Office Suite

Job description

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.

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.

Nearest Major Market: Auburn

Nearest Secondary Market: Opelika