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.

THIS IS HOW YOUR JOURNEY BEGINS
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

WHAT YOU WILL BRING ON THE JOURNEY
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.

WHAT WE OFFER:
* Competitive base salary and performance-based bonus plan.
* An Exciting, Diverse and value based working environment
* Award-winning Corporate University offering personal development and training opportunities.
* Innovative benefits plan which includes: 401K plan, vacation, medical, dental, vision, life, disability, pet insurance, wellness plan, and generous paid maternity/paternity leave

Be You. Be Aptar
Aptar is an equal opportunities employer. We believe that a diverse workforce is key to
our success. We welcome applications from all members of society irrespective of age,
sex, disability, sexual orientation, race, religion or belief.