Associate Scientist, Polymer Synthesis - Exton, PA

Associate Scientist, Polymer Synthesis

Exton, PA

The Associate Scientist, Polymer Synthesis will be responsible for duties related to the research, development, testing and manufacturing of medical device materials, products or technologies in compliance with GMP and ISO standards and participating on project teams consisting of R&D, Commercialization, Advanced Engineering, Manufacturing, Quality, Regulatory, Business Development and Finance within the PMP/project management process. 

Key Responsibilities:

This role involves designing and executing experiments, analyzing results, and staying abreast of emerging trends in biomaterial research. Additionally, this role will be responsible for developing novel biomaterials, collaborating with cross-functional teams, and ensuring the successful translation of research findings into scalable, market-ready solutions. The individual should demonstrate strong problem-solving skills, a deep understanding of biomaterials, and a passion for advancing biomedical technologies. Push the boundaries of biomaterial R&D and contributing to groundbreaking advancements in the field.

Key Responsibilities:

• Generate and process Device Master Record documentation, including process routers, drawings, preventative maintenance procedures, and other written documentation in accordance with GMP requirements to support product development, process development, validations, and manufacturing. Prepare relevant technical sections for product or regulatory submissions.
• Identify, evaluate, and implement improvements (productivity, efficiency, reliability) to existing processes or products. Assist production and quality personnel in the training, initial launch, and validation of new products and processes. Provide technical interface for internal and external stakeholders and customers.
• Develop and fabricate novel biomedical materials and processes from lab-scale level through manufacturing scale-up for the development and production of biomaterials and/or related implants or devices. Assist or take a lead role in the transition of acquired products, processes, and/or equipment into laboratory, manufacturing, or production environments. 
• Plan, construct, and implement Design of Experiments (DOEs) and Risk Management Documentation as required to develop or validate new or existing products. Develop testing methods and complete Test Method Validation (TMV). Prepare protocols and reports, and provide recommendations based on completed experiments and/or tests. Develop and maintain design control systems and procedures that comply with all US/OUS medical device regulations.
• Perform analytical, mechanical, and biochemical assay testing, as well as polymer synthesis, polymer processing, natural materials manufacturing and characterization, according to DSM Quality Systems protocols for raw materials, intermediates, and finished products while maintaining a laboratory notebook and other associated documents. Independently plans, prioritizes, and conducts research.
• Participate in project teams, taking responsibility for assigned tasks and ensuring their completion on time and within budget.

We Bring:

• A rich history and a promising future of bold scientific innovation and passionate creation with our customers;
• A space to grow by encouraging and supporting curiosity and an open mindset;
• A culture that prioritizes safety and well-being, both physically and mentally;
• The opportunity to work for a company where sustainability is much more than a claim and is core to our strategy and purpose;
• A flexible work environment that empowers people to take accountability for their work and own the outcome;
• Barrier-free communities within our organization where every employee is equally valued and respected – regardless of their background, beliefs, or identity;
• A firm belief that working together with our customers is the key to achieving great things;
• An eagerness to be one team and learn from each other to bring progress to life and create a better future; 

You Bring:

• Ph.D., Master's, or Bachelor's degree in polymer science and engineering or in a relevant field.
• Skilled in polymer physical and chemical processing techniques, encompassing polymer synthesis, melt processing (extrusion, injection molding, compression molding), solution processing (film casting), foaming, machining, and sterilization. Experienced in employing analytical techniques such as DSC, TGA, TMA, Rheology, FTIR, GPC, HPLC, as well as mechanical tests including tensile, flexural, torque, torsion, and more for comprehensive polymer characterization.
• Knowledge and experience working with Engineering & Quality tools (Statistics, Six Sigma, DFM, DOE, etc.)
• Computer literacy (i.e. Word, Excel, Project, PowerPoint, Outlook, Pro/E or similar CAD system).
• Understanding of Engineering concepts.
• Understanding of anatomy and surgical procedures.