Associate Scientist, Development
2 weeks ago
We are seeking a creative, experienced, and motivated Associate Scientist to join our growing CMC Process Development team. You will play a critical role in the development of Corner Therapeutic’s novel classes of immune modulating therapies toward in-human trials. Your primary responsibilities will include developing analytical methods to quantitate and characterize drug products to support lead candidate selection, formulation and process optimization and preclinical studies. The successful candidate will possess creative problem-solving skills, keen attention to detail, and the ability to multitask. You will have the opportunity to grow in this position and to learn new skills as you work independently and collaboratively within an interdisciplinary team.
The Responsibilities:
- Research and develop new methods for characterizing new compounds to support pipeline development
- Evaluate and define critical quality attributes of drug substances and drug products to aid in process and formulation development
- Characterize physiochemical properties of drug products (size, zeta-potential, morphology, concentration, stability, interaction with proteins, etc.) using different techniques
- Execute experiments, analyze and organize data, troubleshoot, and communicate findings in team and company meeting presentations
- Proactively identify issues and develop solutions in a collaborative multidisciplinary environment
- Author SOPs and technical reports for regulatory filings
- Support analytical method transfer to CDMOs and CROs, review protocols and reports, provide input for trouble-shooting as needed
- Provide consultation on future analytical needs and manage out-sourced vendors to support analytical needs
- Procure, produce and maintain critical reagents and assay controls
- Maintain thorough and detailed electronic lab notebooks and documentation records
Preferred Qualifications
- BS with 5+ years or MS with 3+ years laboratory experience (industry preferred) in chemistry, biochemistry, material science, chemical engineering, bioengineering, or equivalent
- Hands-on experience with analytical HPLC (RID, ELSD, CAD), plus experience with method development and troubleshooting a must
- Experience with physiochemical characterization techniques (UV-Vis, DLS, microscopy)
- Adaptability to learn and apply new technical knowledge, manage multiple projects, or accommodate changing priorities as new data is generated
- Excellent written and verbal communication skills a must
- Prior experience and track record of working on project teams toward successful drug milestones (INDs, BLAs, etc.) a plus
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