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Analytical Chemist

2 months ago

Lowell, United States RevBio, Inc. Full time
Job DescriptionJob DescriptionJob Description:
The Analytical Chemist will be responsible for characterization of the Tetranite® product across multiple projects and work with the scientists to plan and execute these tasks. This individual will be responsible for method development and validation, testing and analysis of results, and the presentation of data to a cross functional team. This individual will also collaborate with the QC/QA team to perform analytical quality testing for the raw materials, in-process testing, product performance characterization and product conformance. 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;
  • Support the method development and validation plan and execution in vitro tests;
  • Develop methods for analyzing and optimizing therapeutic elution from Tetranite Bone Adhesive;
  • Prepare and support project design reviews and lead discussions related to technical specifications;
  • 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;
  • Design studies to develop the most appropriate analytical tests to ensure compliance to product specifications documented within the RevBio Quality Management System; 
  • Review and curate the data from prior studies and develop scientific justification for its used for proposed indication;
  • 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:
  • Degree in Sciences or Engineering (Chemistry, Biomedical Engineering, or Biochemistry); 
  • Bachelor’s Degree with 3-5 years, Master’s Degree with 1-3 years or PhD with 0-2 years, medical device, pharmaceutical, or biotechnology experience 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;
  • Experience with XRD, NMR, FTIR, SEM, histology is highly 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 ability to prepare and develop manuscripts for publication;
  • 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.