Synthetic / Organic Chemist

Summary of Position

We are seeking a motivated Synthetic Organic Chemist to contribute to our R&D efforts by working closely with a multidisciplinary group of scientists responsible for all technical aspects of developing the MediBeacon fluorophore platform. The selected candidate will be responsible for providing high level organic synthesis support to current research activities, product development scientists, manufacturing groups and special project teams. The individual will also be responsible for collaborating with senior management in developing new project proposals targeted toward discovering new clinical applications of our existing fluorophore platform and developing new fluorophores with unique fluorescent and biological properties. The successful candidate will also work in close collaboration with our process development partners to assist in the discovery of significant fluorophore process improvements. The candidate will also work in close collaboration with patent counsel to write and help protect MediBeacon inventions.

MediBeacon Inc. Overview

MediBeacon is a medical technology company focused on advancing fluorescent tracer agents and transdermal detection technology to provide vital and actionable measurement of organ function.

Measurements of organ function at the point of care and the general application of fluorescent agent technology have the potential to provide information that will help healthcare providers to fundamentally change the standard of care in numerous clinical situations. It is our mission to provide doctors with information that empowers them to make better decisions faster. Use of the technology in a clinical setting offers the possibility for clinicians to provide improved patient care over current practice.

MediBeacon Inc. performs clinical studies with our recently approved transdermal GFR system designed to measure and monitor kidney function. Completion of the clinical human studies, regulatory approval in key markets including the US, and subsequent commercialization of the TGFR System is an on-going focus of the Company. Application of our fluorescent agent technology in several clinical and research areas is also on-going.

The Synthetic Organic Chemist will have the opportunity to be part of a rapidly growing technical team. MediBeacon is focused on bringing to market innovative products, which can meet large unmet medical needs while at the same time contributing to the reduction of overall health care system costs.

Essential Duties and Responsibilities

• The primary responsibility will be the synthetic effort to further develop existing fluorophores and to identify, synthesize, purify and obtain molecular characterization for new patentable fluorophores that have the potential to become the next generation of important new diagnostic agents.
• A major responsibility will be to work closely with the process group to develop and implement commercially viable process improvements in a timely manner.
• Patent preparation and assistance with prosecution is another significant responsibility.
• Work in close collaboration with our analytical chemistry colleagues to maintain analytical instrumentation and assist with troubleshooting problems (hardware and software).
• Interpret analytical data from LCMS instrumentation and apply scientific expertise to help solve specific problems.
• Direct and interpret NMR studies (primarily 1D and 2D), assist with mass spec data interpretation and identify outside collaborators that will assist with delivering other analytical requirements (e.g., elemental analysis, FTIR, x-ray structure determination) as needed in a timely manner.
• Manage deliverables against timelines.
• Draft, review, and/or approve batch records, process validation protocols, design verification protocols and CMC regulatory filings as appropriate.
• Apply scientific fundamentals to troubleshoot complex formulation, stability, and manufacturing issues.
• Record observations and correlate data.
• Prepare detailed research reports for internal and external needs, including publications.
• Manage relationships with collaborators and vendors.
• Communicate constructively with other scientists and managers.
• Serve as the technical lead in cross-functional project teams.
• Assist in drafting, reviewing, and revising department SOPs and other technical documents.
• Mentor junior colleagues.
• Responsible for laboratory safety.

Requirements:

PhD in Synthetic or Physical Organic Chemistry or related fields with 5 years of relevant academic or industrial experience or a Master of Science in Organic Chemistry or related fields with 5 years or a Bachelor's degree in Chemistry or related fields with 10 years of academic or industrial experience.

Extensive hands-on experience and in-depth knowledge of NMR (proton and carbon 1D and 2D techniques), analytical chromatography methodologies (HPLC/UPLC) and preparative chromatography methodologies (reverse phase and normal phase) as well as other commonly employed molecular characterization techniques (mass spec, high resolution MS, MS/MS, elemental analysis, FTIR, etc.)

• Well-versed in regulatory requirements to assure appropriate design and execution of drug development and manufacturing activities.
• In-depth knowledge in manufacturing processes, quality, and regulatory requirements.
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and, where appropriate, assistance with writing regulatory filing documents.
• Demonstrated experience working collaboratively in cross-functional and cross-cultural teams to achieve common goals.
• Familiarity with process improvement strategies and method transfer to production units and validation, impurity identification and minimization / elimination.
• Familiarity with a range of analytical techniques to analyze and quantify small molecules.
• Experience with small molecule mass spectrometry is a plus, including impurity identification and structure elucidation skills.
• Ability to manage multiple projects/priorities simultaneously.