Senior Director of Analytical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and manage strategic and operational initiatives for all analytical development and quality control processes that support late-phase drug substance development, drug product formulation discovery, and manufacturing within the CMC group.

• Supervise the development, qualification, validation, transfer, and lifecycle management of analytical methods for both single and multi-component biological products, focusing particularly on antibodies and oligonucleotides.

• Build and guide an internal analytical team, directly overseeing Managers, Associate Directors, and Directors involved in method development and analytical quality control.

• Provide technical and managerial oversight of external Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), and testing laboratories.

• Work collaboratively with formulation, manufacturing, quality, regulatory, and project teams to establish phase-appropriate, compliant, and efficient analytical strategies that facilitate clinical and future commercial development.

⛳️ Requirements

• A Master’s or PhD in Chemistry, Biochemistry, or Analytical Science is required.

• A minimum of 15 years of experience in analytical development and validation for biologicals, encompassing product development and manufacturing.

• Significant experience with liquid biological injectable dosage forms and drug formulations for both individual and combination products is highly preferred.

• Familiarity with analytical techniques suitable for the characterization of proteins, antibodies, and/or oligonucleotides is strongly desired.

• Proficiency in complex single or tandem mass-spectrometry technologies utilized for characterizing proteins, oligonucleotides, and their impurities is highly regarded.

• A thorough understanding of the manufacturing process development, scale-up, optimization, and validation for dosage forms is essential.

• A solid scientific and operational foundation in optimizing and validating compendial, biochemistry, HPLC, immunochemical, and cell-based assays is necessary.

• A demonstrated ability to provide analytical expertise on program/project teams for pre-clinical and clinical studies employing a wide range of techniques and technologies.

• Experience in a GMP/GLP regulated environment with a deep understanding of phase-appropriate method qualification, validation, sample analysis, GLP, GMP requirements, ICH guidelines, and FDA guidance.

• Proven experience in authoring and reviewing IND and/or BLA submissions.

• Advanced knowledge of principles, concepts, and theories related to product and process development.

• Experience in budget preparation and expense management.

• Proficient in managing CROs and CDMOs.

• Strong leadership, organizational, and project management capabilities.

• Exceptional written and verbal communication skills, along with strong technical writing and document review abilities.

• Capability to operate effectively in a remote and virtual work environment.

• Proven ability to collaborate across cross-functional and geographically dispersed teams.

• Detail-oriented with outstanding documentation practices.

• Knowledge of U.S. and Chinese Pharmacopeia methods for biologic drugs is a plus.

• Proficiency in English is required; Mandarin proficiency is an advantage.

• Willingness to travel domestically and internationally as required.

🏝️ Benefits

• Cash incentive compensation.

• Equity incentive compensation.

• Employee benefits as per the Company’s benefit plans.