Head of CMC

Head of CMC

Treeline Biosciences, Inc. is a drug discovery company developing small molecule drugs for cancer and other serious diseases. With research sites in Watertown MA and San Diego CA, we are committed to bringing forward drugs that benefit patients.

We are seeking a highly motivated, proactive, solution-focused Head of CMC, who will be responsible for the management of Treeline's CMC-related activities. This hands-on position will support CMC aspects of development, including process chemistry, route optimization, GMP manufacture and clinical supply, and formulation development. In this role, the CMC leader will manage multiple priorities in a fast-paced environment, enact quick problem-solving to ensure uninterrupted supply of drug for IND-enabling activities including toxicology studies as well as clinical trials. The successful candidate will have experience of and an interest in working in a small, dynamic environment with broad responsibilities.

Key Responsibilities

• Oversees outsourced manufacturing, including technology transfer, quality control and product / process development activities for drug candidates from late-stage preclinical development through commercialization.
• Identifies, diligences and selects Contract Manufacturing Organizations (CMOs) for process optimization, formulation work, GMP manufacture and supply.
• Works with CMOs to deliver robust, scalable, and cost-effective manufacturing routes.
• Formulates drug substance and drug product development strategy to meet clinical and commercial needs, ensure product quality, facilitate regulatory approvals, and achieve operational flexibility of supply chain.
• Coordinates with Quality Assurance, when applicable, to implement stage-appropriate analytical methods and ensure that all partner CMOs / CROs are in compliance with all relevant regulatory standards.
• Write and / or review CMC sections of regulatory documents and submissions; represent Treeline as the CMC expert in front of regulatory authorities
• Work collaboratively with relevant internal parties to meet current and future needs of Treeline programs, including uninterrupted drug supply for clinical trials.
• Establish and maintain detailed project plans; define risks and continually evaluate ways to optimize timelines and parallel process while appropriately managing risk.
• Build and lead CMC team as CMC responsibilities grow within the organization.

Qualifications

This position is classified as exempt. The anticipated annual base salary range for Director-level candidates who will work in San Diego is $210,771 to $232,220. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

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