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
- Developing phase appropriate drug product formulations in a fast-paced environment to enable clinical trials.
- Review and approve batch records, products specifications, stability protocols, data, and reports.
- Delivering and overseeing execution of formulation optimization and process understanding through rational experimental design, thoughtful execution and clear data interpretation, with emphasis on statistical analysis.
Developing and executing strategy for formulation and process development for later clinical phase and commercial in line with regulatory requirements.
- Work with cross functional peers and CMOs to enable timely delivery of clinical testing material and plan for registration and validation/commercial batches.
- Draft requests for proposals and review service agreements and work proposals
Helps define scientific direction and champion technological innovation for the department.
- Being accountable for troubleshooting and resolving high complexity formulation challenges.
Communicate progress cross functionally and to management leadership.
Author and review technical reports, regulatory filings and responses to deficiency letters, source documents, patents.
- Direct, overview, and coordinate development and manufacturing activities at CDMOs and CMOs and nurture strong partnerships.
- Apply creative ideas and scientific rigor to link small molecule formulation design to thorough process understanding to deliver robust dosage forms that guarantee consistent bio-performance.
- Overcome challenges of small molecules (poor water solubility, first pass metabolism, instability, etc.) applying bioavailability enhancing techniques, selecting appropriate dosage forms in combination with administration routes, as well as solve processability and scalability challenges.
- PhD in Pharmaceutics, Materials Sciences and/or Chemical Engineering with 10 years of industrial experience
- OR Masters in one of these disciplines with 15 years industrial experience.
- You have prior experience with a variety of dosage forms and with drug/devices.
- You have a proven track record of applying fundamental scientific principles to formulation design, development, and process optimization
- 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 email@example.com.