Director of Product Development

Director of Product Development 4.5 4.5 out of 5 stars 604 Liberty Road, Eldersburg, MD 21784 $175,769.36 - $180,000.00 a year Tobacco Technology 2 reviews $175,769.36 - $180,000.00 a year

JOB TITLE

Director of Product Development

EMPLOYER

eLiquiTech, Inc.

GEOGRAPHIC AREA WHERE APPLICANT WILL LIKELY HAVE TO RESIDE TO PERFORM THE JOB AND TRAVEL REQUIREMENTS

Eldersburg, Maryland. Domestic and international travel to the UK, Europe, or India, may be required.

Frequency:

3 to 4 times per year.

DUTIES:

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

Essential job responsibilities:

1. Develops new products and processes that are compliant with pharmaceutical standards for creating nicotine products including synthetic nicotine products to access market opportunities and creating new projects involving complex delivery devices/products, including gums, pouches, lozenges, films, e-liquids and polymer-based systems for nicotine and other actives. 2. Maintain knowledge of the associated product industries and identify market gaps as a foundation for new product offerings. 3. Collaborates with product development partners in the creation of formulations, as well as the manufacturing regulatory requirements, to ensure compliance with US and International Pharmaceutical/Regulatory and Authorities. 4. Acts as a champion for product quality and variation reduction by the production of the appropriate data to substantiate that the product meets the requirements. 5. Develops and designs dosage forms integrating novel approaches like flavor encapsulation techniques, taste masking, flavor complexations, spray-drying techniques, extrusion and spherization, hotmelt granulations, particle coating, pulverization, and plating techniques that produce controlled particle size in a narrow range to maximize product properties. 6. Engineers the manufacturing techniques from lab conception through pilot production to mass production, using scientific methods and appropriately documenting the process. This includes the technology transfer from pilot production to full scale production manufacturing. 7. Create, review and update product design files, including the justification of the design, to conform to business and regulatory needs. 8. Develops the dosage forms with the Quality by Design principle and Design of Experiments to meet global market regulatory requirements as well as create business efficiency, reduce development costs and timelines. 9. Participates in product development, manufacturing and testing teams and advises senior management on product design and potential. 10. 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 to gain and maintain market access for the products that are created. 11. Evaluate prior art to avoid infringement of existing intellectual property of others and potentially generate new intellectual property for ELT. 12. Interacts with subject matter experts and regulatory authorities, as required, including preparation for and attendance at meetings and teleconferences to advance research objectives. 13. Participate as a subject matter expert in international tobacco groups to establish practices, methods, and publications that establish best practices. 14. Utilizes knowledge of conversion of liquid formulation to powder formulations to create new product offerings. 15. Demonstrated project management skills with the ability to manage multiple projects simultaneously. 16. Participates as a subject matter expert with other industry experts, regulators, and professional organizations 17. Ability and willingness to perform needed research personally.

QUALIFICATIONS

This position requires a minimum of 13 years of industrial Research and Development experience. Master's Degree in Pharmaceutical Sciences, Chemistry, or related field required A minimum of 5+ years of hands-on, practical industrial expert level knowledge and experience of spray drying, encapsulation, stable suspension creation, lyophilization, and nano emulsion technologies as demonstrated by sound fundamental knowledge, leading successful product development and process design. This requirement cannot be met by theoretical or non-industrial experience in the execution and delivery of products. At least 8+ years of hands-on, practical industrial knowledge and experience in Research & Development compliant with QBD principles and FDA protocols as demonstrated with real industrial project success with at least 5 of those years being in the development of nicotine-based products. Working knowledge of Microsoft Office and Windows suite of products demonstrated by demonstrated intermediate to expert level skills in Microsoft Word, Excel, and Outlook. Strong written and verbal communication skills demonstrated though sharing information with all employees in one-on-one conversations, in meetings/presentations, professional presentations and through email and memos. Demonstrated ability to work in a result-oriented, challenging environment by a defined history of managing multiple projects simultaneously and delivering results per the established timeline. A minimum of 5 years of successful product development in the tobacco/nicotine industry as demonstrated by products developed and introduced in the tobacco industry. Strong leadership skills with the ability to gain alignment to achieve results as demonstrated by leading teams to accomplish research goals on time and within budget. Cost estimation skills for new projects and processes including equipment costing, raw material cost effectiveness for the launch of cost-effective solutions to enter into the market even in the presence of existing products. This position requires regular presence in the office. Satisfactory background check and execution of Confidentiality and Non-Disclosure Agreement required. Occasional domestic and international travel to the UK, Europe, or India, may be required.

HOURS OF WORK PER WEEK

40

SALARY:

$175,769.36 to $180,000.00 annually.

Benefits include:

discretionary bonuses; medical/dental/vision/disability & life insurance; HSA; 401k; profit sharing; PTO; paid holidays; paid parental leave; tuition reimbursement; gym stipend.

CONTACT:

REPORT OR SEND RESUMES TO

Lisa Taylor, Human Resources Director, eLiquiTech, Inc., 604 Liberty Road, Eldersburg, Maryland 21784. Email resume to Lisa Taylor at ltaylor@tobaccotech.com Apply directly from our careers page at https://www.eliquitech.com/careers