Polymer Process Chemist

About Endomedix Inc.

Endomedix Inc is a start-up medical device company located in Montclair. NJ. We have developed a new class of biomaterials based on natural polysaccharides with 10 issued patents. The 1st application we have developed is for hemostasis specifically targeted towards brain & spine surgery. This class III device will have a major impact in a sector that has not benefited from fundamental innovation since 1945. We have a lean internal team leveraged through a group of renown scientist experts and this position will be ‘hands on’ from the start.

I. Scope of Position

The Polymer Process Chemist will play a central role in scaling chemical processing and materials purification activities from discovery laboratory scale to manufacturing scale. This individual will act as a critical liaison between Endomedix and an external Contract Development and Manufacturing Organization (CDMO) , ensuring the successful transfer and scale-up of processes, purification steps, and analytical control methods.

Post-scale-up, the chemist will support the development of a Good Laboratory Practice (GLP; 21 CFR §58)-compliant quality system to enable production of materials for nonclinical and clinical testing. Additional responsibilities include development of sterilization methods, stability assessments, internal synthesis and purification of polysaccharides, and ownership of analytical methodologies. This is not a research position.

II. Duties and Responsibilities

• Perform hands-on chemical synthesis of derivatized natural polymers using established SOPs.
• Conduct purification processes of polymers per standardized procedures.
• Coordinate with external laboratories conducting H-NMR and SEC-MALS analyses.
• Perform instrument calibrations and materials preparation for laboratory operations.
• Review CDMO procedures to ensure accurate translation of Company protocols and identify potential risks or issues.
• Assist in the development of CDMO work plans and schedules.
• Analyze CDMO test batch results using data from SEC-MALS, SEC-RI, H-NMR, FTIR, UV , and titration methods.
• Review process control data from the CDMO to identify trends and quality metrics.
• Perform QC verification of conformity with SOP for every batch
• Conduct in-house batch testing including:
• Mechanical testing
• Titrations
• SEM imaging
• Viscosity analysis using rheometry
• Support sterilization method development for Endomedix proprietary materials
• Follow and help refine SOPs for established lab techniques.
• Perform statistical analysis on internal and CDMO batch records.
• Assist with the preparation of grant proposals and technical reports.

III. Supervisory Responsibilities

• None

IV. Qualifications

• Ph.D. in organic chemistry, polymer chemistry, material science
• 3+ years hands-on industry experience with organic/polymer synthesis required
• (Experience with polysaccharides strongly preferred)
• Extensive experience with polymer characterization techniques, including: GPC/SEC, Viscometry Rheology)
• Demonstrated ability to troubleshoot and solve complex problems in polymer chemistry and scale-up.
• Prior experience with scaling up of polymers required
• Strong understanding of structure-property relationships in polymers.
• Proficiency in bench-scale wet chemistry and spectroscopy ( NMR, FTIR ).
• Prior lab-based chemical synthesis or analytical/product development experience required.
• Experience using statistical analysis for data-driven decision making is required.
• Willingness to travel between CDMO site and company location as needed. Additional Information
• Salary: Commensurate with experience