Summary

Conducts standard and advanced laboratory activities. Provides scientific and technical leadership in selection and implementation of analytical techniques that may be suitable for the portfolio of projects. Conducts laboratory activities towards development, verification, optimization, transfer, and validation of stage appropriate analytical methods. Drafts and reviews scientific documents that are commensurate with the requirement of global regulatory authorities e.g., US FDA, EMA, MHRA. Designs and conducts physico-chemical characterization studies with a focus on liquid chromatography (LC), spectroscopy, and aerosol performance techniques for orally inhaled and nasal drug products (OINDP) following cGMPs. Leads evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for OINDPs following cGMPs, Transpire Bio EH&S and other relevant guidelines. Analyzes and summarizes analytical data using advanced tools including statistical packages. Drafts sections of regulatory dossiers. Communicates data summaries, study observations and recommendations to Executive Management.

Essential Duties and Responsibilities

• Independently conducts standard and advanced laboratory activities.
• Independently conduct liquid chromatography (LC), spectroscopy, and aerosol performance characterization studies for orally inhaled and nasal drug products (OINDP).
• Conduct physico-chemical and aerosol analytical characterization of OINDPs.
• Conduct characterization studies for evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for OINDPs following cGMPs, EH&S and other relevant guidelines of Transpire Bio, US FDA and other governing bodies.
• Conduct in-depth data analysis including advanced techniques including statistical packages, identify trends and make recommendations, on a routine basis.
• Draft high-quality protocols, methods, reports, standard operation procedures, and submission documents, on a routine basis.
• Conduct execution of analytical activities required for regulatory submission including method development, verification, optimization, transfer and validation protocols of analytical methods.
• Present data analysis, recommendations, and conclusions to senior management on a regular basis.
• Communicate effectively with team members and internal or external customers. Work and communicate effectively with other functional groups.
• Troubleshoot technical issues, analyze data, identify solutions, and implement recommendations.
• Ensure lab work is conducted in accordance with SOPs; follow Transpire Bio safety rules and procedures.
• Comply with all Transpire Bio Corporate guidelines and policies.

Qualification Requirements

• Ph.D. in Analytical Chemistry or Organic Chemistry or Pharmaceutics or related fields with at least 3 years; MSc with at least 5 years or BSc with at least 8 years of experience in pharmaceutical or related fields.
• Must be able to work On-site in Weston, FL. (West of Ft. Lauderdale)
• Must have strong HPLC and Empower experience
• Extensive knowledge of chromatography and spectroscopy based analytical techniques including HPLC, GC, UV, FTIR is a must to have.
• Experience with analytical method development, verification and validation is a must to have.
• Experience with drafting technical documents is a must to have.
• Experience with orally inhaled and nasal drug products e.g., DPI, MDI or nasal drug products is a plus.
• Experience with drafting sections of regulatory dossiers is a plus.
• Good understanding of USP methodologies and ICH guidelines. Extensive knowledge of FDA and cGMP requirements as they apply to the Pharmaceutical industry.
• Strong English language skills including writing ability and oral communication.