Senior Director of Analytical Development

Principal Duties and Responsibilities

• 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.
• 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.
• 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.
• 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.
• Manage and oversee analytical activities performed by CROs, CMOs, and external testing laboratories, ensuring quality, timelines, and cost control.
• Provide technical oversight and decision-making support for outsourced analytical development, validation, and QC activities in a virtual operating model.
• Participate in vendor selection, scope definition, budgeting, and performance management.
• Author, review, and approve analytical sections of CMC documentation for INDs, BLAs, and other regulatory submissions.
• Ensure compliance with cGMP, GLP, ICH guidelines, FDA guidance, and relevant pharmacopeial standards.
• Partner closely with Quality and Regulatory Affairs to support inspections, audits, and regulatory interactions.
• Collaborate closely with formulation discovery and development, drug substance and drug product development, drug substance and drug product manufacturing, quality, regulatory, and project management teams.
• Provide analytical expertise to support formulation discovery, formulation development, process characterization, and late-phase manufacturing activities.

Qualifications

• Master or PhD in Chemistry, Biochemistry, or Analytical Science
• At least 15 years of experience in analytical development and validation activities for biologicals, including product development and manufacturing.
• Experience with liquid biological injectable dosage forms, drug formulations of individual and combination products, is highly preferred.
• Experience with analytical techniques applicable for characterization of proteins, antibodies and/or oligonucleotides highly preferred.
• Experience in complex single or tandem mass-spectrometry technologies used for characterization of proteins, oligonucleotides and their impurities is highly valued.
• Comprehensive understanding of the dosage form manufacturing process development, scale-up, optimization and validation processes.
• Strong scientific and operational background in the optimization and validation of compendial, biochemistry, HPLC, immunochemical and cell-based assays.
• Proven ability to provide analytical expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies.
• Experience working in a GMP/GLP regulated environment and deep understanding of phase appropriate method qualification, validation, sample analysis, GLP, GMP requirements, ICH guidelines and FDA guidance.
• Experience authoring and reviewing IND and/or BLA submissions.
• Expert knowledge of advanced principles, concepts, and theory related to product and process development.
• Experience in preparing budget and managing expenses.
• Skilled at managing CROs and CDMOs.
• Strong leadership, organizational, and project management skills.
• Excellent written and verbal communication skills; strong technical writing and document review capabilities.
• Ability to operate effectively in a remote and virtual work environment.
• Demonstrated ability to collaborate across cross-functional and geographically distributed teams.
• Detail-oriented with exceptional documentation practices.
• Knowledge of U.S. and Chinese Pharmacopeia methods for biologic drugs is a plus.
• Proficiency in English required; Mandarin proficiency is a plus.
• Flexibility to travel domestically and internationally as needed.