Director of Product Development

JOB TITLE

Director of Product Development

• eLiqui
  
  Tech, Inc.

• Eldersburg, Maryland.
• Domestic and international travel to the UK, Europe, or India may be required. Frequency: 3 to 4 times per year.

The Director of Product Development will design and develop new products that comply with FDA and international regulatory requirements.

• Develops new products and processes that are compliant with pharmaceutical standards for creating nicotine products, including synthetic nicotine products, to access market opportunities and create new projects involving complex delivery devices/products such as gums, pouches, lozenges, films, e-liquids, and polymer‑based systems for nicotine and other actives.
• Maintain knowledge of the associated product industries and identify market gaps as a foundation for new product offerings.
• Collaborates with product development partners in the creation of formulations and the manufacturing regulatory requirements to ensure compliance with US and International Pharmaceutical/Regulatory Authorities.
• Acts as a champion for product quality and variation reduction by producing the appropriate data to substantiate that the product meets requirements.
• Develops and designs dosage forms integrating novel approaches such as flavor encapsulation techniques, taste masking, flavor complexations, spray‑drying techniques, extrusion and spherization, hotmelting granulations, particle coating, pulverization, and plating techniques that produce controlled particle size in a narrow range to maximize product properties.
• Engineers manufacturing techniques from lab conception through pilot production to mass production, using scientific methods and appropriately documenting the process, including technology transfer from pilot production to full‑scale manufacturing.
• Creates, reviews, and updates product design files, including justification of the design, to conform to business and regulatory needs.
• Develops dosage forms with the Quality by Design principle and Design of Experiments to meet global market regulatory requirements while creating business efficiency, reducing development costs, and shortening timelines.
• Participates in product development, manufacturing, and testing teams and advises senior management on product design and potential.
• Key member of a cross‑functional team to prepare, review, compile, and submit regulatory dossier module documents related to DMF, ANDA 505(b)(2), TPMF, and PMTA submissions, including preparation and submission of required regulatory filings to support product approval and maintain market access.
• Evaluates prior art to avoid infringement of existing intellectual property and potentially generate new intellectual property for ELT.
• Interacts with subject‑matter experts and regulatory authorities as required, including preparation for and attendance at meetings and teleconferences to advance research objectives.
• Participates as a subject‑matter expert in international tobacco groups to establish best practices, methods, and publications.
• Utilizes knowledge of conversion of liquid formulations to powder formulations to create new product offerings.
• Demonstrates project‑management skills with the ability to manage multiple projects simultaneously.
• Participates as a subject‑matter expert with other industry experts, regulators, and professional organizations.
• Has ability and willingness to perform needed research personally.

• Minimum of 13 years of industrial Research and Development experience.
• Master’s Degree in Pharmaceutical Sciences, Chemistry, or related field required.
• Minimum of 5+ years of hands‑on, practical industrial expertise in spray drying, encapsulation, stable suspension creation, lyophilization, and nano‑emulsion technologies, demonstrated by successful product development and process design.
• At least 8+ years of hands‑on, practical industrial R&D knowledge compliant with QBD principles and FDA protocols, with at least 5 of those years in nicotine‑based product development.
• Working knowledge of Microsoft Office and Windows suite, with intermediate to expert level skills…