Senior Formulation Chemist
Cybin has an exciting opportunity for a Senior Formulation Chemist to join the growing team!
A leading biotechnology company, Cybin is focused on and dedicated to progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for psychiatric disorders. To learn more about Cybin, visit https://www.cybin.com.ABOUT THE POSITION
Working in the R&D department, reporting directly to the SVP, CMC, the Senior Formulation Chemist will be responsible for internal development and stability of new drug product formulations and manage the outsourcing and development of drug products in advanced development for future clinical trials. This position can work out of our Boston office.RESPONSIBILITIES
- Leads the development and testing of drug product formulations and drug-device combinations.
- Performs formulation development studies and testing in the laboratory.
- Experience in oral and inhalation delivery a plus.
- Ensures drug product development activities and timelines are aligned with project goals
- Manages drug product development activities at external vendors with applicable regulatory and quality requirements including providing input into the design of experiments, managing timelines, reviewing technical and batch manufacturing documentation and ensuring that Cybins needs are met by the vendor
- Prepares pharmaceutical development reports and other technical documentation required for regulatory submissions including authoring, review and approval of requisite sections.
- Works collaboratively across internal stakeholder functions such as Project Management, Manufacturing Operations Clinical and Regulatory to meet program goals, including representation on CMC development teams
- Ensures that all work is conducted in accordance with applicable policies and procedures, cGMP and regulatory standards and guidelines
- Any other duties and responsibilities which may be assigned from time to time.
- PhD in Pharmaceutical Sciences or related discipline with at least 7 years of relevant experience in pharmaceutical formulation development
- Experience in leading drug product development and manufacturing activities
- Experience in formulation development for small molecules.
- Strong project management skills and the ability to prioritize and align drug product development activities with broader project goals
- Knowledge of current regulatory guidance and experience in managing IND and NDA filings
- Excellent interpersonal, technical writing, and oral communication skills
- Skilled at independently organizing project goals, completing long-term projects on time and within budget and fully integrating them into the work of other functions
- A team player who is able to collaborate effectively with a broad range of internal functions.
Cybin Inc. is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to ethnicity, color, national origin, age, religion, sexual orientation, gender identity or expression, family or parental status, veteran status, neurodiversity status, disability status or any other basis protected by applicable law. We are proud to provide employment accommodation during the recruitment process. Should you require an accommodation, please contact us at HR@Cybin.com and we will work with you to meet your accessibility needs. We welcome applications from all qualified candidates.