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Salary: USD 234,500 - 286,338 / annual
Treeline Biosciences seeks a Head 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 oral dose and parenteral drug product programs.
In this role, you will operate in a 100% outsourced environment, establishing and managing phase-appropriate analytical strategies from preclinical through commercialization. You will oversee external analytical operations and ensure compliance with global regulatory expectations and GMP requirements across assigned programs.
Key responsibilities include:
**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. This includes small molecule drug substance methods, oral dose drug product methods (tablets, capsules, gelcaps, pediatric formulations), and intermediate methods (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, in-process controls, release testing, and stability programs. Ensure timely release and disposition support for clinical materials. Manage investigations involving out-of-specification, out-of-trend, 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 and implement new technologies and outsourced capabilities as needed.
You 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.
**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. Demonstrated deep experience in analytical development activities supporting small molecule drug substance and drug product development and manufacturing with emphasis on oral solid dose, parenteral, and pediatric formulations. Demonstrated success in developing and validating discriminating dissolution methods for one or more oral solid dose 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, and relevant ICH guidances. Experience with biologics testing methodologies desirable. Strong command of 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, Project), iStability, and JMP or similar statistical tools. High level of personal integrity, commitment to excellence and to patients. Experience in developing and commercializing drugs for oncology is preferred.
