My client is expanding and seeks a fully remote Principal Engineer for oligo and small molecule drug development and manufacturing. The ideal candidate will take on the following tasks:
* Support drug substance process development, technology transfer, process scale-up, and process characterization activities.
* Manage external CMOs for drug substance process development and manufacturing activities.
* Support GMP manufacturing and leads late phase API development activities towards commercialization.
* Bring knowledge of global regulations and prepars source documents to support regulatory filings.
* Collaborate closely with cross functional teams.
The ideal candidate will possess the following qualities:
* MS/PhD and 10+ years including experience with drug substance process development, unit operations, and late-stage drug development programs.
* Experience working with CDMOs and vendors
* Demonstrated ability for critical thinking and innovation and ability to understand and communicate risks, and develop and execute contingency plans.