Careers

CMC Project Manager

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To strengthen our CMC team in Greenville, SC, we are looking for a CMC Project Manager.

 

Your responsibilities include…

• Monitoring and guiding the day-to-day CMC activities for profiling and development of our drug candidates from research stage to full pre-clinical development to enable first-in-human clinical phase I studies (project goals, timelines, costs)

• Manage and supervise activities such as method transfer and establishment, process development and analytics at our CMOs in collaboration with external consultants

• Actively collaborate with our R&D team in identifying promising early-stage drug development candidates

• Co-author and review regulatory documents such as briefing books for scientific advice meetings with governmental authorities and IMPD

• Monitor and maintain the project documentation

 

You’ll succeed because with your scientific background, you have:

• Ph.D. in chemistry, pharmaceutics, chemical engineering or closely related disciplines

• Good knowledge of drug delivery systems

• Prior relevant experience in CMC project management, process development, technical transfer, support of GMP manufacturing and technical troubleshooting is a plus

• Understanding of relevant guidelines and GMP requirements for manufacturing of drug substance and drug product

• Strong communication and organizational skills

 

You’ll love it because you will:

• Contribute to a high-impact drug development platform project in high unmet need orphan disease areas

• Work in a multinational and interdisciplinary team

• Have an exciting and flexible working environment in a small, dynamic and highly committed team

• Get personal and professional development through responsibilities across a broad range of subjects

 

In return, Elastrin Therapeutics offers very competitive salaries with excellent benefits and the chance to progress your career within a truly innovative organization. Elastrin Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence, and business need.

 

About Elastrin Therapeutics

Elastrin Therapeutics is a US and UK based biotech which leverages a platform technology to develop medicines that restore hardened and damaged arteries and tissues, by specifically targeting degraded elastic fiber. This allows to reverse damage caused by the deadliest diseases and has the potential to save billions of lives. Our lead compound is planned to receive a conditional market approval for our orphan indication in 2025, followed by the launch of our second candidate in 2027.

 

If this sounds like you, please send your CV to mb@elastrin.com.