Senior Scientist I/II, Formulation 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 Formulation Sciences, this position will help execute late-stage strategies to support aggressive program timelines, as well as manage external partners and suppliers.  This candidate will be responsible for CDMO oversight during the manufacturing execution of pivotal stability batches, process characterization and optimization for commercial readiness, and authoring of reports and regulatory documents.  The candidate will also manage cross functional collaborations to ensure an uninterrupted supply chain.  This is an excellent opportunity to join a small, nimble team and have a substantial impact across the organization.

Key Responsibilities:

• Manage multiple CROs and CMOs to coordinate drug product manufacturing for continuous clinical supply.
• Collaborate with Quality to review and approve master and executed batch records, manage deviations and oversee investigations.
• Monitor and interpret drug product characterization/optimization data to ensure an optimal manufacturing control strategy and design space for commercial readiness.
• Identify Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA) and perform technical/quality risk assessments based on QTPP, CQA and Quality by Design (QbD) principles.
• Coordinate and collaborate with CMC Operations, Process Chemistry and Supply Chain to monitor and plan appropriately to support drug product clinical needs.
• Collaborate with Analytical Sciences for statistical analysis of R&D/GMP data.
• Collaborate with Marketing, Supply, Regulatory, and other teams as appropriate to plan for final drug product/packaging presentations.
• Work with Regulatory Affairs/Publishing Preferred Provider CRO's to contribute to author, manage and coordinate DP-related sections for global regulatory submissions.

Qualifications:

• PhD in pharmaceutics, chemical engineering or material sciences with 4+ years or Master’s degree with 7+ years as a team member of various drug development programs
• Comprehensive understanding of small molecule and solid oral dosage form development, regulatory and quality
• Skilled in establishing, maintaining, and managing relationships with CROs, CMOs and testing labs

• Ability to effectively prioritize and manage tasks in a fast-paced environment

• Excels in a results-driven, highly accountable environment where your work makes a clear impact on the direction of the company
• Team player, who listens effectively and invites response and discussion from team members

• A collaborator who communicates in an open, clear, complete, timely and consistent manner; ability to communicate status, roadblocks and recommended solutions with management

• Ability to travel 30%-50%