Senior Director of Analytical Development

The Senior Director of Analytical Development is responsible for providing strategic and operational leadership for all analytical development and analytical quality control activities supporting late‑phase drug substance development, drug product formulation discovery, and drug product manufacturing and formulation development within the CMC group. This role oversees analytical method development, qualification, validation, transfer, and lifecycle management for single‑ and multi‑component biological products, with emphasis on antibodies and oligonucleotides.

The Senior Director will lead and develop an internal analytical organization, directly managing a team of Managers, Associate Directors, and Director across method development and analytical QC, while providing technical and managerial oversight of external CROs, CMOs, and testing laboratories. The position requires close collaboration with formulation, manufacturing, quality, regulatory, and project teams to ensure phase‑appropriate, compliant, and efficient analytical strategies that support clinical and future commercial development

Principal Duties and Responsibilities include the following:

Strategic and Technical Leadership
- Define and execute the analytical development and analytical QC strategy across drug substance and drug product programs, ensuring alignment with CMC, regulatory, and corporate objectives.

- Provide scientific and technical leadership for analytical methods supporting identity, purity, potency, content, impurities, degradation products, and stability of biological drug substances and drug products, including multi‑component combinations.

- Establish phase‑appropriate analytical control strategies for late‑phase development, including in‑process controls, release testing, and stability programs.

- Drive CQA generation and support QTPP development for late-stage project development .

- Drive control of product specifications in collaboration with other functional groups.

- Oversee development and implementation of novel or non‑standard analytical approaches required for complex biological products.

People and Organization Leadership
- Directly oversee and develop a team of at least four professionals at the Manager to Sr. Director level, including: Method Development and Analytical Quality Control, including stability, testing records, and data analysis

- Set clear objectives, provide coaching and mentorship, conduct performance evaluations, and support professional development of the analytical team.

- Ensure effective coordination and workload prioritization across method development and analytical QC functions.

Method Development, Validation, and Lifecycle Management
- Oversee analytical method development, qualification, validation, transfer, and supplemental validation activities across internal and external laboratories.

- Ensure robust implementation, execution, troubleshooting, and continuous improvement of core analytical and bioanalytical assays.

- Review and approve analytical protocols, reports, SOPs, and technical documentation suitable for regulatory submission.

Analytical Quality Control and Stability Oversight
- Provide leadership and oversight for analytical QC activities, including GMP testing, stability studies, data trending, and lifecycle monitoring.

- Manage product and raw material specifications and product shelf-life/stability protocols.

- Ensure appropriate oversight of stability protocols, shelf‑life assignments, data review, and interpretation in support of late‑phase programs.

- Oversee review of testing records, analytical data packages, Certificates of Analysis, and investigation reports.

- Lead or support investigations related to OOS, OOE, deviations, and analytical discrepancies, including root cause analysis and corrective actions at CROs/CMOs.

External Partner and Vendor Oversight
- Manage and oversee analytical activities performed by CROs, CMOs, and external testing laborator