Treeline Biosciences, a clinical-stage biotechnology company advancing precision medicines, is seeking an experienced Director/SD, Chemical Development to drive the development, scale-up, manufacturing, and regulatory readiness of our small-molecule portfolio. This role will be central to establishing a robust supply chain for our portfolio compounds About the Position The Director/SD, Chemical Development will have overall responsibility for leading and managing development and manufacturing activities for drug substance, DS intermediates, and starting materials for one or more Treeline programs. The scope of the role encompasses process development, scale-up, and characterization/design space mapping of the manufacturing process of a drug candidate, up to and including process performance qualification (PPQ).

Operating within a virtual (100% outsourced) business model, the incumbent will have accountability for CDMO selection and the development of strong and enduring business partnerships supporting assigned programs. The successful candidate will also assume a key leadership role in the development, review, and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and TPP/QTPPs. The successful candidate will be an experienced process chemist with significant experience in CMC development and commercialization of small molecules and an in-depth understanding of critical-path activities and interdisciplinary connections associated with late-phase development and product registration.

S/he will possess strong leadership, management and communication skills, ensuring that internal and external business partners understand and respect program goals, objectives, priorities, and timelines.

Responsibilities

Lead and manage cross-functional teams engaged in external cGMP manufacturing of drug substance, DS intermediates, and starting materials. Provide technical and functional project leadership on drug substance process development, manufacturing, and CDMO partner management. Lead and manage process transfers and associated site implementation to support supply chain expansion activities and continuous improvement initiatives.

Monitor, track and trend process performance. Develop and implement data analytics to support investigations and provide an historical baseline for future operational and process-related improvements. Support investigations, root cause identification and CAPA implementation associated with manufacturing deviations and associated quality events.

Work closely with Analytical Development/QC, Quality Assurance, Regulatory CMC, Supply Chain and external manufacturing operations to ensure operational excellence with respect to timelines, budgets, and attainment of technical, regulatory and business goals/milestones. Lead the selection of drug substance CDMOs based upon core capabilities, capacity and track record of regulatory compliance; establish KPIs to monitor site technical, quality and business performance. Develop and maintain strong relationships with CDMO business partners and participate in Steering Committees as appropriate.

Review/approve technical reports, controlled GMP documents and CMC content for Module 3 CTDs. Develop and manage scope, milestones, interdependencies, budgets and timelines associated with drug substance program deliverables. Ensure cross-functional alignment of drug substance program deliverables with overall program strategy.

Continuously monitor external business and regulatory environments; identify risks and establish mitigation plans and/or best practices to proactively address Drug Substance and supply chain risk. Represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities.

Qualifications

Director/Sr Director, Chemical Development