Research Chemist

Company Overview

RevBio, Inc. is an innovative medical device firm focused on regenerative bone adhesives that enhance fracture repair and bone fixation outcomes. Its main product, TETRANITE®, is a bioengineered bone adhesive undergoing multiple FDA-approved clinical trials and backed by patents valid through 2042. TETRANITE® is designed for applications in neurosurgery, orthopedics, and dentistry, addressing a market valued over $10 billion. Characteristics include fast mechanical stabilization, wet-field adhesion, controlled biodegradability, and a scaffold for natural bone regeneration. The technology is inspired by the natural adhesive proteins of the sandcastle worm.

Role Overview

The Research Chemist will focus on characterizing TETRANITE® products across various projects, collaborating with scientific colleagues to plan and perform studies. This role includes developing and validating analytical testing methods, executing SOP-driven assays, analyzing experimental data, and presenting findings to cross-functional teams. Coordination with quality control and assurance teams will be crucial to conduct raw material and in-process manufacturing tests, as well as final product performance evaluations. Interaction with external partners and management of their data are also required.

Key Responsibilities

• Conduct analytical laboratory testing and develop relevant test methods utilizing techniques such as Liquid Chromatography.
• Assist in the development and validation of in vitro test methods.
• Create methodologies for analyzing and optimizing therapeutic release kinetics from products.
• Perform tests and report data on both raw materials and finished goods using various analytical instrumentation.
• Design analytical studies conforming to RevBio's Quality Management System requirements to verify product specifications.
• Analyze prior study data to discern trends and build scientific rationale to advance technology understanding.
• Formulate test protocols in compliance with international and domestic test standards.
• Develop, author, and review test methods and standard operating procedures (SOPs).
• Support troubleshooting efforts for test methods and equipment; ensure scheduled calibration of analytical instruments.
• Maintain documentation fulfilling RevBio's Quality Management System, including managing corrective and preventative actions, non-conformities, and lot release records related to testing.
• Apply creative problem-solving, engineering principles, and statistical analysis to develop innovative solutions.
• Perform other relevant duties as assigned.

Required Expertise and Abilities

• Proficient working in cross-disciplinary teams.
• Capable of managing project timelines independently or as part of a team.
• Experienced in chemical, physical, and material characterization testing for product evaluation.
• Self-motivated to push projects towards successful completion.
• Skilled at rallying support from both internal and external resources.
• Strong communicator regarding project progress and outcomes.
• Willing to comply with regulatory standards including FDA 21 CFR Parts 58 and 820, and ISO 13485.
• Flexible and cooperative to handle various responsibilities essential for overall success.

Qualifications

• Degree in Chemistry, Biomedical Engineering, Biochemistry, or related scientific/engineering fields.
• Bachelor’s degree holders with 2 to 4 years’ experience or Master’s degree holders with 1 to 3 years’ experience in medical devices, pharmaceuticals, or biotechnology preferred.
• Preferred experience in drug delivery systems, release kinetics, and pharmacokinetics.
• Strong wet lab background including physical, thermal, and moisture analyses.
• Required expertise with HPLC-UV-MS and highly desirable experience with NMR, FTIR, SEM techniques.
• Preferred knowledge in crystalline phase characterization using XRD or similar methods.
• Meticulous attention to detail.
• Excellent verbal and written communication skills.
• Authorization to work in the United States.
• Demonstrated competence understanding and applying design controls and product development processes.