Scientist/Senior Scientist, Analytical Sciences

IDRX is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. IDRX aims to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong response to therapy. IDRX’s lead program is IDRX-42, designed to inhibit key genetic drivers and drug-resistant mutations of KIT in gastrointestinal stromal tumor (GIST). Founded in 2021, IDRX’s leadership team has extensive experience in drug development and collectively has been involved in the discovery, development, and commercialization of more than 10 approved drugs.

About the role:

Reporting to the head of Analytical Sciences, this position will help execute late-stage analytical strategies for small molecule oral drug substance and drug product activities to support aggressive program timelines. This candidate will analyze and interpret data from a variety of sources and effectively and accurately communicate key points to internal (DS and DP process development, supply chain, CMC regulatory, quality, leadership) and external (CROs/CMOs) stakeholders.  The candidate will provide technical leadership to support registration stability studies, commercial readiness, and continuous clinical supply. This is an excellent opportunity to join a small, nimble team and have substantial impact across the organization.

Responsibilities:

• Manage and oversee the coordination of planning and execution of analytical chemistry activities at CROs/CMOs in support of clinical phase development programs:
  • Transfer of analytical methods (starting material, intermediate, DS, DP) to new suppliers, associated troubleshooting and optimization.
  • Ongoing analytical support for clinical manufacture (batch record, analytical data review).
  • Coordinate and collaborate with technical leads to oversee Quality investigations /change controls/OOS/OOT
• Stability program maintenance, data trending and statistical evaluation, shelf-life/retest period assignment.
• Act as a key player in analytical commercial-readiness activities including defining specifications and control strategies, design of experiments and risk assessment support, as needed.
• Author and review development reports, protocols, investigations, CMC sections of regulatory submissions and lead responses to inquiries by health authorities.
• Participate in the build out of the CMC group by defining analytical strategy and procedures; authoring and/or reviewing relevant SOPs.

Qualifications:

• BS, MS, or PhD in Analytical Chemistry or related field and 2+ years experience in pharmaceutical or biotech industry
• Knowledge and hands-on lab experience with analytical instrumentation (chromatographic separation techniques and detection methods, spectroscopic and characterization techniques, dissolution) and demonstrated ability to troubleshoot those methodologies
• Experience in late clinical phase analytical development for small molecule NCEs
  • Method development, troubleshooting, validation/transfer, lifecycle management
  • Small molecule solid oral dosage form experience preferred
  • Virtual CMO management preferred
• Knowledge of cGMP compliance, industry standards, requirements for clinical and commercial regulatory filings (IND, IMPD through NDA, MAA)
• An appreciation for data-driven and risk-based strategies (analytical DOE, predictive stability, statistics)
• Demonstrated ability to self-motivate and effectively prioritize and manage multiple products and projects
• A team player, who listens effectively and invites response and discussion
• A collaborator who communicates in an open, clear, complete, timely and consistent manner
• Willingness and ability to travel as needed (5 to 10%)