Head of Analytical Development & Quality Control

About the role

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.

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. amorphous 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.

Requirements

Education: Ph.D./MS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemical Engineering, or related scientific discipline preferred.

Experience: 12+ years (Ph.D.) / 15+ years (MS) of progressive pharmaceutical or biotechnology analytical development experience.

• Demonstrated deep experience in analytical development activities supporting Small