Company Description: RevBio, Inc. is a medical device company pioneering regenerative bone adhesives to improve outcomes in fracture repair and bone fixation. The company’s flagship product, TETRANITE®, is a bioengineered “bone glue” currently under evaluation in multiple FDA-approved clinical trials and supported by a global patent portfolio extending through 2042. TETRANITE is designed for use across neurosurgical, orthopedic, and dental applications, targeting a total addressable market of over $10 billion. The adhesive offers rapid mechanical stability, wet-field adhesion, controlled biodegradability, and serves as a scaffold for natural bone remodeling. Founded on biomimicry of the sandcastle worm’s protein-based adhesive, RevBio focuses on translating simple chemistry into innovative solutions for complex musculoskeletal defects. Our team thrives on innovation, collaboration, and a shared passion for science that matters. At RevBio, employees enjoy a culture of curiosity, growth, and meaningful impact.
Role Description: The Research Chemist will be responsible for the characterization of TETRANITE® products across multiple projects and will work with fellow scientists to plan and execute these tasks. This individual will support the development of key test methods and validation activities. The Research Chemist will be required to follow standard operating procedures (SOPs) to conduct the necessary testing and analysis of experimental results, and will be required to present data to a cross functional team. The Research Chemist will also collaborate with the quality control and quality assurance (QC/QA) team to perform analytical quality testing for raw materials, in-process manufacturing testing, and final finished product performance characterization and conformance testing. This individual will also interface with external collaborators and manage the data acquired from them.
Essential Duties and Responsibilities:
- Design and conduct lab-based analytical characterization testing and the development of related test methods using techniques such as Liquid Chromatography;
- Support development of, and execution of, test method development and validation by conducting in vitro tests;
- Develop methods for analyzing and optimizing the release kinetics of various therapeutics from the product;
- Perform testing and report the resulting data on both raw material components and final manufactured product using different analytical techniques and instrumentation;
- Design studies to develop the most appropriate analytical tests to ensure compliance to product specifications documented within the RevBio Quality Management System (QMS);
- Review and curate the data from prior studies to isolate and identify trends and develop scientific justification for the use data to advance the understanding of this technology;
- Develop test protocols that are consistent with applicable international and domestic test standards;
- Develop, write, and review test methods and SOPs;
- Assist in troubleshooting the test methods and equipment as needed and ensure the calibration of analytical instrumentation on a scheduled basis;
- Ensure the completion of proper documentation to comply with RevBio's QMS requirements which include, but are not limited to, assisting with the issuance of corrective actions, preventative actions (CAPAs), non-conformities, and other lot release documents pertaining to analytical tests;
- Think creatively, problem solve, develop innovative solutions based on sound engineering skills and statistical analyses; and
- Perform other tasks as may be required from time to time.
Specialized Knowledge and Skills:
- The ability to work in a multi-disciplinary team environment;
- The ability to support project timelines independently or within a project team;
- The ability to develop and perform product testing, including, but not limited to, chemical, physical, and material characterization testing;
- The internal motivation and ability to assist driving a project to completion;
- The ability to gain support from various resources both within and outside the company;
- The ability to communicate effectively the status of a project (or projects);
- The ability and willingness to receive direction for all facets of management as it relates to Compliance Regulations (i.e., FDA 21 CFR Parts 58 and 820 and ISO 13485); and
- The willingness to assist in all necessary areas in order to achieve overall success.
Qualifications:
- Degree in Sciences or Engineering (Chemistry, Biomedical Engineering, or Biochemistry);
- Bachelor's Degree with 2-4 years of experience, or Master's Degree with 1-3 years of experience in medical device, pharmaceutical, or biotechnology is preferred;
- Experience with drug delivery development, drug release kinetics, and pharmacokinetics is preferred;
- Wet lab experience is a must with general physical, thermal, and moisture characterization knowledge;
- Experience with HPLC-UV-MS is a must; and other analytical techniques such as NMR, FTIR, SEM is highly preferred;
- Experience with characterization and analysis of crystalline phase using XRD or other such techniques is highly preferred.
- A demonstrated attention to detail;
- Proficient in verbal and written communication;
- Authorized to work in the US; and
- A demonstrated proficiency in understanding and applying design controls and their development.
