Analytical Chemist

About the job

The Analytical Chemist will be responsible for planning and executing physical and chemical characterization across multiple projects. This individual will assist in executing the testing, and analysis of results. The analytical Chemist will actively interface with engineers, surgeons, and the management team to characterize and develop medical device products. This individual will perform analytical quality testing for product characterization and product conformance and may also interface with external collaborators and manage the data acquired from them.

Essential Duties and Responsibilities:

• Design and conduct chemical, physical, and material characterization testing of the product.
• Develop test methods that must be verified and validated;
• Develop methods for analyzing and optimizing drug elution and conduct associated tests and studies;
• Conduct wet lab-based testing including, but not limited to, the preparation of samples for elution and homogeneity testing;
• Support the development of various product formulations through the design and execution of in vitro and in vivo testing;
• Conduct preliminary leachable and extractable studies to assess product packaging solutions;
• Support the development of design specifications based on hazard and risk assessments as well as user needs identified through market research activities such as voice of customer interviews and surveys;
• Prepare and support project design reviews and lead discussions related to technical specifications;
• Work with the engineering & scientific team to develop specifications for suppliers and oversee external testing in order to meet internal development timelines and budgets;
• Perform testing and report the resulting data on both raw material components and final manufactured product using different analytical techniques and instrumentation;
• Under guidance from senior engineering & scientific staff, design studies to develop the most appropriate analytical tests to ensure compliance to product specifications documented within the RevBio Quality Management System;
• Develop test protocols that are consistent with applicable international and domestic test standards;
• Develop, write, and review Standard Operating Procedures (SOPs);
• Develop test methods for quality control documentation;
• Troubleshoot test methods and equipment as needed;
• Calibrate analytical instrumentation on a scheduled basis at the direction of the Quality Department;
• Think creatively, problem solve, develop innovative solutions based on sound engineering skills and statistical analyses;
• Perform other tasks as may be required from time to time.

Essential Education, Skills Environment Education and Work Experience

• Bachelors/ Masters Degree in the Sciences (Chemistry or Biochemistry or other related disciplines) or equivalent certification through an accredited program;
• Wet lab experience is a must with general physical, thermal, and moisture characterization knowledge;
• Experience with analytical chemistry (such as HPLC, NMR, FTIR, SEM) is preferred;
• Knowledge of drug delivery development, drug release kinetics, and pharmacokinetics is preferred;
• A demonstrated attention to detail;
• Proficient in verbal and written communication; and
• A demonstrated proficiency in understanding and applying design controls and their development;

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 maintain design control documentation and project files;
• 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.