SummaryThis role is responsible for supporting the development, optimization, and lifecycle management of formulations used for cleaning, disinfection, and reprocessing of medical devices and healthcare environments, with a focus on medical cleaning chemistries including enzymatic detergents, disinfectants, and device refurbishing agents. The Chemist position requires hands-on formulation experience, a strong understanding of antimicrobial and enzymatic systems, and familiarity with regulatory and performance requirements for healthcare applications.
In This Position, You Will Have the Opportunity To- Develop and optimize enzymatic detergents, high- and low-level disinfectants, and refurbishing chemistries for medical devices and healthcare surfaces
- Design and execute laboratory studies to evaluate cleaning efficacy (protein, blood, biofilm removal), enzyme activity, antimicrobial efficacy, material compatibility, and stability
- Select and evaluate raw materials including enzymes (protease, amylase, lipase), surfactants, oxidizers, quaternary ammonium compounds, peracetic acid systems, and corrosion inhibitors
- Support disinfection validation testing (e.g., bactericidal, virucidal, fungicidal claims) in collaboration with internal teams or external labs
- Partner with cross-functional teams (Regulatory, Quality, Clinical Affairs, Manufacturing) to ensure compliance with FDA, EPA, ISO 15883, AAMI, and other applicable standards
- Assist in scale-up, technology transfer, and manufacturing troubleshooting for commercialization
- Investigate and resolve product performance issues, including residue formation, material compatibility, and process variability
- Maintain detailed documentation for formulations, validation data, technical reports, and regulatory submissions
- Monitor industry trends in infection prevention, device reprocessing, and emerging antimicrobial technologies
- Work in a laboratory and pilot-scale formulation development environment, interacting with manufacturing and sterile processing environments as needed.
- Handle bio-relevant soils, chemicals, and antimicrobial agents under strict safety protocols.
What You Need to Succeed in This Position- Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, or related field
- 3-6 years of experience in formulation development, preferably in medical, healthcare, or regulated cleaning products
- Working knowledge of:
- Enzyme-based cleaning systems and stability considerations
- Surfactant systems and soil removal mechanisms (proteins, lipids, polysaccharides)
- Disinfectant chemistries (e.g., oxidizing agents, aldehydes, quats)
- Experience designing experiments and interpreting performance data
- Strong understanding of laboratory safety and chemical handling practices
- Technical depth in cleaning, enzymatic, and antimicrobial chemistry
- Familiarity with antimicrobial efficacy standards (e.g., AOAC, ASTM, EN methods), preferred
- Knowledge of regulatory frameworks (FDA 21 CFR, EPA FIFRA, EU MDR, REACH), preferred
- Product performance testing using ultrasonic machines and automatic washers with TOSI plates and challenge substrates, preferred
- Accelerated shelf life and stability studies using an incubator, preferred
- Strong analytical and problem-solving skills
- Ability to translate laboratory results into practical application performance
- Cross-functional collaboration in regulated environments
- Attention to detail and documentation rigor
- Project management and time prioritization
