ABOUT THE COMPANY:
Aquavit Pharmaceuticals, Inc. is a high-tech pharmaceutical company that provides a comprehensive range of innovative pharmaceutical, biotech, and medical device technologies. Aquavit Pharmaceuticals, Inc. focuses on personalized medicine to improve patients' health, maximize the efficiency of our medical community, and support the pharmacoeconomic of payers.
At Aquavit, we hold a fundamental belief that our science has the potential to improve patients’ lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs. We are a company driven by the knowledge that our work is important and the desire to make a difference. Aquavit offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.
DUTIES/TASKS AND RESPONSIBILITIES:
Daily R&D Operational Activities:
Develop recommendations to optimize product development results and procedural technique for medical device technology focused on intradermal delivery of drugs and therapeutics
Lead Aquavit’s R&D Division in product development activities such as design, engineering, manufacturing, while complying with medical device regulations (FDA, CE)
Support product development activities for Aquavit’s ACK/BCC drug delivery devices, targeted for skin cancer
Support product development activities for Aquavit’s AQV-1122, targeted for intradermal delivery of vaccines (Immunology)
Develop clinical trial plans for pipeline products
Develop translatable product designs for clinical applications of Aquavit’s core microchannel delivery technology, the underlying mechanism of action, and the competitive landscape in the fields of dermatology, neuroscience, immunology and oncology
Collaborate with clinical sites, physicians, and patients
Collaborate closely with clinical partners to define clinical performance goals and perform risk assessments. Validate performance of the device relative to those goals
Working in a small team setting, attain a high level of professional knowledge through familiarity with clinical literature related to Aquavit’s products and pipeline devices
Inter departmental and regulatory activities:
Conduct market research on competitive product offerings, new market prospects & product development ideas
Advocate potential strategic partnerships such as academic institutions, research organizations, companies, etc.
Support Marketing & Sales team by providing technical support and answering questions raised by customers
Review documents/reports for regulatory submissions as per US FDA guidelines and other international cGMP norms.
Coordinate FDA submissions including but not limited to Pre-IND meetings, IND, BLA, 510(k) submissions, etc.
Review additional information/responses as requested by regulatory agencies
Ensure compliance to relevant regulations as standards as listed by the FDA
Address product/process changes and deviations from regulatory commitments
Intellectual Property Portfolio Management:
Oversee Aquavit’s Intellectual Property portfolio- manage timely deadlines for responses and filing
File new patent applications & USPTO office actions & responses
File new trademark applications & USPTO/WIPO office actions & responses
Bachelor’s or Master's Degree is required in Bio-Medical Engineering or Bio-Engineering or Integrated Biomedical Engineering & Business.
2-3 years of medical device and pharmaceutical experience
Previous start-up experience is a must. Must be a self starter
Theoretical knowledge of business operations and management is required. Experience working in small teams preferred
Prior experience in product development activities including prototyping, designing, and biomedical engineering
Proven problem solving and analytical skills, including statistical analysis. Experience with Minitab or other statistical software is a plus
Ability to work independently and in collaboration with other team members
Excellent verbal, visual, and written communication of ideas, processes, and conclusions. The ability to synthesize data for different audiences, including executive leadership
Experience working with marketing and sales teams in a technical support role is preferred
Knowledge of FDA regulations, good clinical practices, and design control for medical devices
Knowledge of USPTO patent submissions preferred
• Attention to detail.
• Proven expertise in thriving in a fast paced, results-oriented environment.
• Ability to manage multiple projects and deadlines and to adapt to changing work priorities.
• Strong team building and collaboration skills across the organization.
• Experience working with engineers, physicians and patients is a plus.
• Ability to manage highly confidential material in an appropriate manner.