Location: NY office or remote in the US
- A fast-paced environment where you’ll work on a wide range of topics
- Be a major contributor to the success of a well-positioned, well-financed, rapidly growing biotech company
- Become part of creating a radically new and impactful paradigm shift in drug development and patient care
- An open, results-driven, and meritocratic start-up culture
- To work from where you want when you want, and with the device and equipment you choose
- The opportunity to participate in the company's success via a share option plan
- Ensure timely phase appropriate development and validation of analytical methods to support in Drug Substance and Drug Products processes and finished products testing by contract manufacturers
- Review analytical test methods, protocols, stability protocols, release and stability data, and technical reports
- Develop phase appropriate DS and DP specifications in collaboration with CMC and Regulatory colleagues and CDMOs/CMOs.
- Closely monitor stability programs and trend stability data to relate it to retest and shelf-life extensions
- Actively collaborate with DS process chemistry, formulation, CMC project/documentation management, and Regulatory to maintain high quality source documents and draft/review CMC sections of regulatory filings
- Draft necessary SOPs to define the analytical activities within ATAI and in collaboration with contract laboratories
- Communicate progress cross functionally and to management.
Manage analytical activities with CROs within budget
- Apply creative ideas and scientific rigor to overcome challenges and ensure robust analytical methods are developed and validated as per international guidance (ICH) across multiple projects
- Coordinate and build effective collaboration with CDMOs, CMOs and CROs Direct, and nurture strong partnerships to enable timely deliverables of high-quality products and documentation
- PhD in Analytical Chemistry or Physical Chemistry with 10+ years of bio-pharma industry experience
- Or Masters in one of these disciplines with 15+ years industrial experience
- You possess a theoretical and hands on experience with a wide array of analytical techniques to enable the coordination of work with contract laboratories (Chromatography, Spectroscopy, Thermal, X-Ray powder diffraction, Particle Size Distribution, Wet Chemistry, microbiology, Dissolution)
- You have analytical experience with various dosage forms and with drug/device is a plus.
- You have a proven track record of applying fundamental scientific principles and thorough compliance experience to analytical development, investigations, and control strategy
- You have a thorough knowledge of ICH, FDA and EMA guidance documents
- You possess in depth knowledge and prior practice of domestic and European regulatory filings (IND, IMPD, NDA, MAA)
- You have a strong track record in contributing to cross-functional teams in advancing projects
- You are highly empathetic with an outstanding ability to work multi-culturally
- You are willing to work in a challenging, fast-paced environment and to adapt to new situations as they arise
How to apply
Join us to improve the lives of millions suffering from a real unmet medical need - Apply today via the "Apply for this Job" - button on the top right. Please note that we can only accept applications from people that have a valid US work permit.
If you have any questions, don't hesitate to contact us at firstname.lastname@example.org.