Head of Analytical Development & Quality Control

he 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 Qualifications

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 molecule Drug Substance and Drug Product development and manufacturing with emphases on oral solid dose, parenteral, and pediatric formulations.
• Demonstrated success in developing and validating discriminating dissolution methods for 1+ OSD tablets.
• Proven track record advancing products from early development through late-stage clinical development and/or commercialization.
• Demonstrated success working with CDMOs and global development partners.
• Additional experience in development and implementation of analytical methods to support antibody/ADC manufacturing is desirable.

Technical Expertise

Strong working knowledge of:

• Analytical method development and validation
• Stability programs and specification setting
• Quality control laboratory operations
• GMP analytical testing
• Small molecule drug substance characterization and phase-appropriate method development.
• Oral solid dose characterization and phase-appropriate method development, including discriminatory dissolution method development
• ADC analytical characterization
• Experience with Biologics testing methodologies desirable
• Strong command of and facility working with relevant ICH quidances
• Regulatory submissions and health authority interactions

Leadership Competencies

• Strategic thinker with strong business and scientific acumen.
• Excellent project management and organizational skills.
• Strong communication and influence skills across scientific, quality, regulatory, and program teams
• Ability to travel (20%) to CDMO domestic and international sites.
• Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project), iStability, and JMP (or similar statistical tools).
• High level of personal integrity, commitment to excellence and to our patients.
• Experience in developing and commercializing drugs for oncology is preferred.