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Salary: USD 193,877 - 232,875 / annual
Treeline Biosciences seeks a Director of Analytical Development & Quality Control to provide strategic and operational leadership for analytical development, characterization, method validation, transfer, and quality control activities supporting a growing pipeline of small molecule and antibody-drug conjugate (ADC) programs. This role emphasizes drug product and ADC-focused analytical activities in a 100% outsourced environment.
You will establish and manage phase-appropriate analytical strategies from preclinical through commercialization, oversee external analytical operations, and ensure compliance with global regulatory expectations and GMP requirements. As a key member of the Technical Operations team, you will collaborate cross-functionally with Drug Substance, Drug Product, ADC production, Regulatory Affairs, Quality Assurance, and external CDMOs/CRO/consultants to advance programs efficiently through development milestones while building scalable analytical and quality control capabilities.
Key responsibilities include:
**Analytical Development Leadership:** Develop and execute phase-appropriate analytical strategies for small molecule and ADC development. Lead analytical characterization efforts including small molecule oral solid dose drug product method development and ADC conjugation support. Provide technical oversight for development, qualification, validation, and lifecycle management of analytical methods. Serve as the company's analytical subject matter expert for ADC development, supporting characterization of monoclonal antibodies, cytotoxic payloads, linkers, conjugates, and related impurities. Guide implementation of advanced analytical techniques (HPLC, UPLC, LC-MS, HRMS, SEC, CE-SDS, icIEF, HIC, ELISA, bioassays) and collaborate with external CDMOs to define CQAs and control strategies.
**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 (INDs, IMPDs, BLAs, NDAs, CTAs). Ensure analytical approaches align with ICH, FDA, EMA, and other global regulatory expectations. Support establishment of specifications and analytical control strategies. Participate in regulatory agency interactions and inspections. Ensure compliance with cGMP, GLP, GCP, and data integrity requirements. Partner with Quality Assurance and support audits of contract testing laboratories.
**External Partner Management:** Manage relationships with contract laboratories and CDMOs. Oversee method transfers, validation activities, and technical governance. Establish performance metrics and ensure delivery against timelines. Evaluate and implement new analytical technologies.
**Requirements:**
Education: Ph.D. or MS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemical Engineering, or related scientific discipline preferred.
Experience: 12+ years (Ph.D.) or 15+ years (MS) of progressive pharmaceutical or biotechnology analytical development experience with demonstrated expertise in both oral solid dose (OSD) drug product analytical development and biologics/ADC analytical development. 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.
Technical Expertise: Strong working knowledge of analytical method development and validation, stability programs and specification setting, quality control laboratory operations, GMP analytical testing, oral solid dose characterization and phase-appropriate method development (including discriminatory dissolution methods), ADC analytical characterization, biologics testing methodologies, ICH Q1/Q2/Q3/Q6/Q7/Q8/Q9/Q10/Q14 guidance, and 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 MS Office (Word, Excel, PowerPoint, Project) and JMP or similar statistical tools. High level of personal integrity and commitment to excellence. Experience in developing and commercializing drugs for oncology is preferred.
