Analytical Associate Scientist - Exton, PA

Analytical Associate Scientist

Exton, PA

The Analytical Associate Scientist will assure that dsm-firmenich Biomedical products are of consistent and high quality by: Assuming responsibility 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.

At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work to not only benefit our People, Customers & Communities but also drive business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.

Key Responsibilities

• Develop a solid IP track record (patents, trade secrets, freedom to operate) for the business based on unique concepts that provide DSM Biomedical with a freedom to operate well beyond the normal standard. Stay up to date with competitor IP and contribute to patent searches and IP justifications.
• 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-firmenich 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 competitive compensation package, with comprehensive health and welfare benefits
• A place to grow and develop.
• A company that is purpose-led and performance-driven in a corporate culture that values people and planet.
• The opportunity to work on growing brands and build on a strong foundation.
• The chance to make improvements and make an impact on the business.
  
  

You Bring

• Ph.D., Master's, or Bachelor's degree in analytical chemistry, chemistry or polymer science with a minimum of 4 years of experience.
• Highly skilled in two or more analytical techniques.
• Inorganic analysis experience is a plus with knowledge of techniques such as ICP, XRD, Surface area, particle size analysis, etc.
• Experienced with analytical method development, validation, and implementation.
• Demonstrated skill in analytical instrumentation trouble shooting and repair.
• Understanding of polymer and natural materials science.
• 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.
• Good written and oral communications skills.
• Ability to function or lead as a part of a team.
  
  

dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate: there’s a place for everyone at dsm-firmenich.

As a committed equal opportunity employer, we ensure our recruitment practices are inclusive and fair. We encourage the recruitment of a diverse workforce, representative of the communities in which we work, by using inclusive language, diverse interview panels, diversified sourcing strategies. Selection is based on qualifications, competency, experience, performance history and fit with the team to advance fair and equitable opportunity.

Employment decisions are based upon job-related reasons regardless of an applicant's race, color, ethnicity, national origin, religion, gender, gender identity or expression, sexual orientation, age, disability, backgrounds, genetic information, protected veteran status, or any other status protected by law.

We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.

Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency’s fees, percentages or similar.