Head of Analytical Development & Quality Control

The Head of Analytical Development & Quality Control will provide strategic and operational leadership for analytical development, characterization, method validation, transfer, and quality control activities supporting a growing pipeline of small molecule Oral  Dose and parenteral Drug Product programs.  The incumbent will have deep experience in analytical activities required to support early-stage to late-stage drug substance as well as  oral solid dose and parenteral drug products. Additional experience in antibody/ADC manufacturing-focused analytical activities is desirable. This individual will be responsible for operating in a 100% outsourced environment to establish and will manage phase-appropriate analytical strategies from preclinical through commercialization, overseeing external analytical operations, and ensuring compliance with global regulatory expectations and GMP requirements for assigned programs.

As a key member of the Technical Operations team, this leader will collaborate cross-functionally with Medicinal Chemistry, Toxicology, Clinical Pharmacology, Drug Substance, Drug Product, , Regulatory Affairs, Quality Assurance, and external CDMOs/CROs/consultants to advance programs efficiently through development milestones while building scalable analytical and quality control capabilities for a rapidly growing organization.

Key Responsibilities

Analytical Development Leadership

• Build and lead a small team of analytical development and quality control chemists capable of developing and executing phase-appropriate analytical method development and testing strategies and activities supporting Chemical and Drug Product development and eventual commercialization of the Treeline portfolio, including:

• Phase-appropriate small molecule drug substance method development and testing

• Phase-appropriate small molecule oral dose drug product method development and testing (tablets, capsules, gelcaps, pediatric formulations, etc.)

• Phase-appropriate small molecule oral dose drug product intermediate method development and testing (e.g. amporphous solid dispersions)

• Provide technical oversight for development, qualification, validation, and lifecycle management of analytical methods.

• Ensure analytical methods support process development, formulation development, manufacturing, release testing, and regulatory submissions.

Quality Control Oversight

• Establish and lead QC strategies across clinical manufacturing operations
• Oversee external GMP testing activities including raw materials, IPCs, release testing and stability programs.