Senior Chemical Categorization Specialist (2608)

Senior Chemical Characterization Specialist

Are you passionate about advancing chemical analysis in the Medical Device and Pharma industry? Do you have expertise in regulatory standards and hands-on experience with state-of-the-art analytical techniques? Are you eager to join the Biosafety & Chemical Compliance team within New Business Development at a company making a unique impact on global healthcare?

This is your chance to join a rapidly growing company that invests in your development. At FeMD, you’ll not only make an impact on the production and development of our products but also have the opportunity to grow and develop your own skills.

Every 2 seconds, FeMD products help surgeons and nurses control bleeding and prevent complications in surgical procedures. We make seconds count in surgical care—and we need you on our team!

Analytical chemistry within pre-clinical development
As a Chemical Characterization Specialist, you’ll be an integral member of the Biosafety & Chemical Compliance team, part of the larger New Business Development area. This group consists of 50+ professionals working across early and late-stage development, as well as lifecycle management of medical devices and combination products.

In this role, you’ll serve as the Subject Matter Expert (SME) for all chemical characterization studies, ensuring technical excellence and compliance with regulatory standards. You’ll also contribute to optimizing our chemical characterization test program, implementing improvement initiatives, and collaborating with key stakeholders both internally and externally.

Your expertise in extractables and leachables (E&L) testing and chemical compatibility assessments will be critical in this position.

Your role
As our new Chemical Characterization Specialist, your primary tasks will include:

• You will oversee and monitor chemical characterization (extractable and leachable) studies conducted either internally or in collaboration with external contract laboratories (study monitor role).
• Perform and interpret chemical characterization studies following regulatory standards, including ISO 10993-18, USP 661, USP 665, and USP 1663.
• Manage and interpret results from advanced analytical techniques, including HPLC-MS, ICP-MS, HS-GC-MS, GC-MS, NVR (Non-Volatile Residue analysis), FTIR (Fourier Transform Infrared Spectroscopy)

• Conduct solvent compatibility studies to ensure material integrity and product safety for Class III medical devices.
• Partner with cross-functional teams to provide expert input on material selection, product development, and regulatory submissions.
• Review and approve protocols, study plans, and reports, ensuring compliance with relevant external standards.
• Stay updated on advancements in analytical methodologies and regulatory updates to maintain cutting-edge expertise.

About you
You’re a proactive, detail-oriented professional with a strong background in analytical chemistry and hands-on experience in E&L. You have a natural ability to take on responsibility and thrive in a collaborative, team-oriented environment. Your entry to this job requires an advanced degree in Chemistry, Analytical Chemistry, or a related field (Master’s or PhD preferred).

We are looking for a candidate that would like to work in a collaborative self-managing team environment, who enjoy a supportive environment that values professional growth and team success, and who meet some of the below requirements:

• Self-driven and outgoing with a positive, can-do attitude.
• The ability to work independent and thoroughly, with a high-quality mindset.
• Excellent problem-solving skills, attention to detail, and ability to manage multiple projects.
• Experience with E&L testing is required – having experience with absorbable medical devices is considered an advantage
• Excellent communication skills in English - both written and verbal, incl. technical writing.
• Experience with GMP/GDP in the pharmaceutical or medical device industry is an advantage.

Don’t meet every single requirement? If you are excited about this role, but you cannot meet all requirements, we encourage you to apply for the role anyway. You may be just the right candidate for this role.

We offer a truly purpose driven workplace where you can have real impact
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.

We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun 😊

Some of the facts and a little piece of history
Ferrosan Medical Devices develops and produces a portfolio of medical devices used in surgical care. Our portfolio consists of various hemostatic products to minimize bleeding challenges in surgery and electromechanical medical devices to perform breast biopsies. We are an international company with products registered in more than 100 countries. Our products are marketed in collaboration with global MedTech partners. New ideas are developed and matured from the first thought to finished implementation in production. And we manage the business with an uncompromising focus on quality based on current GMP requirements.

Want to join our team?