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Senior Project Manager, CSP Applications Development (Auburn, AL, US, 36832) @ Aptar Group

Auburn, AL, US, 36832OnsiteFull-timePosted 3 days ago

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<p><strong>Job Opportunity – Senior Project Manager, CSP Applications Development</strong><br><strong>WHO ARE WE </strong><br>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. </p> <p><br>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. <br>We have manufacturing facilities in North America, Europe, Asia and South America and over 13,000 dedicated employees in 18 different countries. </p> <p><br><strong>YOU SHOULD WORK HERE BECAUSE WE: </strong><br>• attract and develop high performing people. <br>• promote a diverse and inclusive work environment. <br>• allow for failure by allowing people to make mistakes through an open and trusting environment. <br>• invest in the development of employees through local, regional and global career opportunities. <br>• contribute to the communities where we reside. <br><strong>WHAT’S NEW WITH APTAR </strong><br>We have an exciting position open in North America: Senior Project Manager, CSP Applications Development, reporting to Kasey Myers, Applications Development Manager. <br>This position will be based in Auburn, AL. </p> <p><br><strong>THIS IS HOW YOUR JOURNEY BEGINS </strong> <br>Responsibilities<br>Include but are not limited to the following: <br>• Define, create and communicate a commercialization path for new medical devices or pharmaceutical product solutions from concept creation through product development.<br>• Create documentation to define system requirements and specifications, managing internal and external stakeholders, through development, validation, documentation and release of products.<br>• Leads cross-functional project execution for platform technologies, ensuring compliance with ISO 9001 and ISO 13485 standards<br>• Act as a customer-facing representative for platform technologies, including participation in industry trade shows and technical discussions<br>• Collaborate with internal stakeholders including R&amp;D, Regulatory, and site teams to ensure successful delivery of services related to pre-clinical to Phase II within oral solid dose drug development<br>• Assist in North America product sustainability as a technical lead, coordinating Operations, R&amp;D, and Regulatory Teams for product recyclability initiatives to align with regulatory critical guidance<br>• Work with a multi-disciplinary product development team and cross business unit to develop, evaluate, document, and introduce new products.<br>• Review all designs and validations to ensure all specifications are being met<br>• Conduct appropriate project risk assessments and define a mitigation plan<br>• Develop approaches to sustain and communicate success and progress across global stakeholders<br>• Support sales efforts in the bid process to gain repeat, and/or new, long-term business as needed.<br>• Partners with Industrial Designers to incorporate sponsor user requirement specifications to create innovative solutions<br>• Work with intellectual property counsel to submit IP invention disclosure and ensure all data and drawings are provided for provisional applications<br>• Participate in monthly Project Phase Reviews and provide updates to assigned projects along with status update on current phase<br>• Runs concurrent projects effectively<br>• Other duties as assigned</p> <p><strong>WHAT YOU WILL BRING ON THE JOURNEY </strong><br><span style="text-decoration:underline">Education –</span><br>• BS Degree in Engineering field (Chemical, Electrical, Mechanical, Biomedical, or related field) required.<br>• PMP (Project Management Professional) certification strongly preferred.<br><span style="text-decoration:underline">Experience-</span><br>• 5-7 years of leading product development and project/program management experience within the Medical Device or Pharmaceutical industry<br>• Proven experience managing cross-functional teams and customer-facing projects.<br>• Experience with IND, NDA, NDA 505(b)2, and ANDA drug development preferred<br>• Familiarity with ISO 9001 and ISO 13485 quality management systems and regulatory standards.<br>• Experience with design verification, validation, and documentation processes.<br>• Demonstrated success in mentoring and performance management of direct reports<br><span style="text-decoration:underline">Technical Skills-</span></p> <p>• Strong working knowledge of design controls and regulatory requirements (US, EU, Japan, China).<br>• Proficiency in ICH-GCP/ISO 14155 and clinical research regulatory frameworks.<br>• Skilled in documentation, testing, and design-control procedures.<br>• Proficiency in statistical and analytical tools, including design of experiments (DOE).<br>• Broad knowledge of polymeric materials and processing techniques (extrusion, injection molding, thermoforming) preferred.<br>• Familiarity with sustainability and recyclability initiatives in product development.</p> <p><span style="text-decoration:underline">Soft Skills &amp; Tools-</span></p> <p>• Excellent written and verbal communication skills; able to present to stakeholders at all levels.<br>• Strong organizational and time management skills; capable of managing concurrent projects.<br>• Ability to work independently and collaboratively in a virtual or cross-site environment.<br>• Proficiency in Microsoft Office Suite (Project, Excel, Word, PowerPoint).<br>• Ability to interface effectively with Sales, R&amp;D, Regulatory, and Operations teams.</p> <p><strong>WHAT WE OFFER: </strong><br>• Competitive base salary and performance-based bonus plan. <br>• An Exciting, Diverse and value based working environment <br>• Award-winning Corporate University offering personal development and training opportunities. <br>• Innovative benefits plan which includes: 401K plan, vacation, medical, dental, vision, life, disability, pet insurance, wellness plan, and generous paid maternity/paternity leave</p> <p><br><strong>Be You. Be Aptar </strong><br>Aptar is an equal opportunities employer. We believe that a diverse workforce is key to <br>our success. We welcome applications from all members of society irrespective of age, <br>sex, disability, sexual orientation, race, religion or belief.</p>

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Senior Project Manager, CSP Applications Development (Auburn, AL, US, 36832) at Aptar Group | ResuMinder Jobs