Director, Process Chemistry
Cybin has an exciting opportunity for a Director, Process Chemistry 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
Reporting directly to the SVP, CMC, the Director of Process Chemistry is responsible for providing leadership and technical oversight on Cybin sponsored research and development activities conducted internally and at external Contract Manufacturing Organizations (CMOs). This role will lead technical efforts in API development and process validation. The candidate must have the ability to generate innovative solutions to R and D and manufacturing problems as needed together with cGMP manufacturing experience and a high level of proficiency with all technical principles of synthetic organic chemistry. This position can work out of our Boston office.RESPONSIBILITIES
- Provide leadership in process chemistry for API manufacturing projects within the Cybin pipeline.
- Ability to direct internal and external (CRO) synthesis efforts of new development compounds.
- Design and develop API manufacturing processes and manage activities conducted at CMOs.
- Coordinate with analytical, quality, and regulatory staff to ensure activities being conducted at CMO partners are performed according to Cybins expectations and appropriate standards
- Lead process chemistry efforts in the design, development and characterization of manufacturing processes such that they are suitable for process validation.
- Prepare Requests for Proposals (RFPs) to support vendor selection activities
- Prepare Technology Transfer Packages (TTPs) to support technical transfer activities between CMOs
- Assemble and write development reports
- Author and edit submissions to regulatory agencies
- Any other duties and responsibilities which may be assigned from time to time.
- BS/MS/PhD, Organic Chemistry
- Pharmaceutical industry experience in pharmaceutical development and manufacturing of small molecule APIs (minimum 10 years with a BS/MS; minimum 7 years with a PhD)
- Expert proficiency with handling, synthesis, route development, isolation, purification, and characterization of organic molecules
- Proven track record of working in a project leadership role with CMO partners to deliver on project milestones
- Direct experience with developing and characterizing manufacturing processes suitable for process validation
- Working knowledge of cGMP and regulations applicable to international regulatory agencies is required; experience working in a cGMP manufacturing environment is highly desirable.
- Strong problem-solving and troubleshooting abilities.
- Ability to work independently and in a team environment.
- Strong organizational skills
- Excellent oral, written and interpersonal communication skills
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. We thank all those who apply. However, only those selected for an interview will be contacted.