Senior Project Manager, CSP Applications Development

Senior Project Manager, CSP Applications Development

Job Opportunity – Senior Project Manager, CSP Applications Development WHO ARE WE At Aptar, we use insights, design, engineering and science to create innovative packaging technologies that build brand value for our customers, and, in turn, make a meaningful difference in the lives, looks, health and homes of people around the world. Every day, Aptar creates "a-ha moments" for its customers and their consumers and patients by continually bringing innovations to market that convert non-dispensing packaging into breakthrough product-dispensing systems, including those that give people more effective ways to put on their favorite fragrance, kids the opportunity to pour ketchup without making a mess and patients connected technologies that help them more easily adhere to treatment.

We have manufacturing facilities in North America, Europe, Asia and South America and over 13,000 dedicated employees in 18 different countries.

YOU SHOULD WORK HERE BECAUSE WE:
• attract and develop high performing people.
• promote a diverse and inclusive work environment.
• allow for failure by allowing people to make mistakes through an open and trusting environment.
• invest in the development of employees through local, regional and global career opportunities.
• contribute to the communities where we reside.

WHAT'S NEW WITH APTAR We have an exciting position open in North America:
Senior Project Manager, CSP Applications Development, reporting to Kasey Myers, Applications Development Manager. This position will be based in Auburn, AL.

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

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…