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. • Ensure timely release and disposition support for clinical materials. • Manage investigations involving OOS, OOT, deviations, and laboratory events. Regulatory and Quality Support • Author and review analytical sections of regulatory submissions including: INDs, IMPDs, BLAs, NDAs, and CTAs. • Ensure analytical approaches align with ICH, FDA, EMA, and other global regulatory expectations. • Support establishment of specifications and analytical control strategies throughout the product lifecycle. • May participate in regulatory agency interactions and inspections. • Ensure compliance with cGMP, GLP, GCP, and data integrity requirements. • Partner closely with Quality Assurance to maintain inspection readiness. • Support audits of contract testing laboratories and manufacturing partners. External Partner Management • Manage relationships with contract laboratories and CDMOs. • Oversee method transfers, validation activities, and technical governance of external laboratories. • Establish performance metrics and ensure delivery against development and manufacturing timelines. • Evaluate/implement new technologies/outsourced capabilities as needed. Required Qualification