Job Summary:
Responsible for leading all aspects of ARx Research and Development Department.
Essential Functions:
- Leads Department in developing new products, formulations and technologies consistent with business priorities, customer needs and application requirements; determines early-stage program feasibility and communicates recommendation to the business team.
- Develops, recommends, and implements division-wide technical research policies and programs to support profitable growth, while also establishing general policies for ARx's Research and Development Department.
- Establishes and administers procedures for discovering new technologies, developing new products, and modifying existing products, ensuring compliance with applicable quality systems and regulations. Develop and author white papers, technical reports, and case studies for marketing and publishing purposes, communicating the company's technical expertise, capabilities, and successful project outcomes.
- Ensure that all CMC activities comply with global regulatory requirements (e.g., FDA, EMA), industry standards (e.g., GMP, ICH) and internal SOPs.
- Prepare and review CMC sections for regulatory filings (Pre-IND, IND, NDA, IMPD, etc.) and ensure the appropriate documentation for regulatory inspections.
- Provide technical guidance to clients and internal teams to resolve CMC-related issues and ensure seamless project execution.
- Facilitate the technology transfer process from R&D to manufacturing, ensuring that all CMC documentation supports scale-up and commercialization activities.
- Ensures establishment and maintenance of adequate records for formulas, processing methods, testing methods and product construction standards; assures organization of technical information in frameworks which readily afford business organizational efficiency.
- Ensures R&D development activities will maintain ARx's leadership role in developing innovative technologies in the oral thin film, transmucosal and transdermal drug delivery spaces.
- Works closely with customers and project teams to ensure the successful progression of developmental projects to commercialization.
- Participates in annual and long-range business planning; develops technical strategies consistent with overall business strategy; effectively positions the business for sustainable and profitable commercial revenue streams.
- Leads business in formulation and implementation of intellectual property strategy yielding significant competitive advantage; monitors and leads the business in effectively understanding relevant intellectual property landscape; maintains adequate records to support intellectual property-related actions; assists Patent Counsel in obtaining patent protection and assuring freedom to operate.
- Coordinates invention disclosures from scientists and decides which findings merit patent filing.
- Works with patent attorneys to draft claims and review filings.
- Oversees freedom-to-operate (FTO) assessments to ensure projects don't infringe competitors' IP.
- Manages confidentiality agreements (CDAs) and material transfer agreements (MTAs) when collaborating with clients or partners.
- Work closely with the marketing team to produce high-quality content that showcases the company's innovations and positions the organization as a leader in the drug delivery space.
- Maintains current awareness of pharmaceutical and drug delivery technical progress via avenues including:
- Industry peer networking
- Monitoring relevant literature
- Participating in industry groups
- Attending relevant conferences
- Forecasts operating and capital expense requirements and manages to budgets.
- Effectively manages technical organization including but not limited to assuring up-to-date position descriptions, establishment and auditing of performance expectations, annual reviews, individual development plans, and training.
- Ensures all subordinate associates are fully oriented and trained; assure a safe work environment and that all practices are conducted in a safe and effective manner; manage with safety, associate well-being and environmental practices as a priority.
- Effectively communicates functional status within function as well as across division.
- Conducts all aspects of position in a professional, respectful manner consistent with ARx Guiding Principles; embraces 6S LEAN culture; organizes personal work areas and appearance consistent with corporate and divisional professional image.
Additional Responsibilities:
- Performs other duties and responsibilities as assigned.
Job Specifications:
- Advanced degree (PhD) in a scientific and/or engineering discipline with focus in chemistry, pharmaceutical sciences, pharmacology, biotechnology or related area.
- 20+ years technical and 10+ years laboratory environment management experience in pharmaceutical and/or drug-delivery business; preferably experienced with transdermal, transmucosal oral thin film, and fast dissolve applications/technologies.
- Experienced with FDA-regulated business and regulatory requirements necessary to operate in compliance with FDA 21 CFR 211 regulations; familiarity with all stages of pre-clinical and clinical therapeutic offering development.
- In-depth understanding of CMC documentation preparation, regulatory requirements and guidelines related to oral thin film, transmucosal, and transdermal products.
- Demonstrated expertise in successfully preparing and submitting regulatory filings to the U.S. Food and Drug Administration (FDA), leading to the approval and commercialization of pharmaceutical products.
- Deep understanding of in-vitro and in-vivo models for testing of oral thin films and transdermal drug delivery devices.
- Experienced with DEA regulations for handling controlled substances (e.g. Schedules II-V).
- Proven experience in managing intellectual property (IP) for pharmaceutical technologies, including patents and trade secrets.
- In-depth understanding of drug pharmacokinetics and pharmacology
- Strong leadership, influencing, interpersonal, negotiation and communication skills.
- Expert in design control and statistical analysis.
- Advanced proficiency in using standard desktop software applications.
- Ability to travel 10-15% of the time (including some international).
