Director/Sr. Director, Analytical Sciences

Role Summary

The Director/Senior Director, Analytical Sciences is responsible for leading development, qualification and transfer of robust analytical methods for complex biological molecules, including monoclonal antibodies, multi-specific, antibody drug conjugates (ADC). This role will oversee early-phase and late-phase method development, qualification, transfer to QC, establish specifications for clinical & commercial products, and define Critical Quality Attributes (CQAs), Control Strategies, and Product Characterization strategies. This position will be a core member of the leadership team of BioPharmaceutical Development (BPD) department.

Responsibilities

• Manage a team of scientists and associates on developing and qualifying robust analytical methods, including physio-chemical, potency, residual, and product characterization assays.
• Provide technical and strategic leadership on developing analytical methods for release and characterization of Drug Substance and Drug Products.
• Oversee transfer of analytical methods to Quality Control at all stages of clinical development for release and stability testing. Support Quality Control team on method validation as needed.
• Lead and coordinate with CMC and regulatory teams to establish specifications for release and stability of Drug Substance and Drug Product, in order to support IND-enabling studies and late-stage development.
• Participate and lead BLA-enabling activities, including product characterization, comparability studies, CQA assessment, design of the analytical Control Strategy.
• Author and review technical reports, regulatory submissions, and address questions from Health Authorities.
• Manage sample analysis to support development activities for internal and CDMO projects.
• As part of BPD Leadership team, champion cross-functional communication to align short- and long-term needs within BPD and other stakeholder departments. Provide recommendations on strategic plans and long-term objectives for BPD department.
• Manage the performance and development of team members. Cultivate a cohesive, innovative, nimble and productive team environment.

Qualifications

• B.S. in Chemistry, Chemical Engineering or relevant life sciences discipline with a minimum of 15 years of related experience
• OR M.S. in Chemistry, Chemical Engineering or relevant life sciences discipline with a minimum of 12 years of related experience
• OR PhD in Chemistry, Chemical Engineering or relevant life sciences discipline with a minimum of 10 years of related experience
• Experience in developing and qualifying biochemical, biophysical and biological test methods for protein-based biotherapeutics
• Experience in successful transfer of methods to Quality Control within the company or to external collaborators
• Experience in establishing specifications for product release and stability studies, and defining phase-appropriate test strategies.
• Experience in authoring regulatory filings (INDs, BLAs), and authoring and implementing Control Strategy
• 8+ years’ experience in team management. Demonstrated capability of effectively managing supervisors and individual contributors, as well as developing and mentoring team members.

Skills

• Proven track record of leading analytical development activities for protein-based biotherapeutics.
• Knowledge of Quality by Design principles, Process Analytical Technologies (PAT), cGMP, and CMC requirements for regulatory filings globally, especially in the US and Europe.
• Strong writing and verbal communication skills, and effectiveness in communicating with interdisciplinary and cross-functional teams.
• Understanding of FDA, EMA, ICH guidelines associated with release, stability, and characterization assays.
• Capability of working in a fast-paced team environment, achieving on-time delivery of robust methods and test results, and prioritizing work across multiple projects.

Education

• PhD, MS, or BS in Chemistry, Chemical Engineering or relevant life sciences discipline with related experience as specified above.

Additional Requirements

• Experience in a variety of recombinant molecules, including monoclonal antibodies, bispecific antibodies and antibody drug conjugates.
• Experience in defining strategy for late-stage biologics drug development.
• A track record of promoting platform and technology development.
• A recognized technical expert in method development and innovation for biotherapeutics.
• Author of publications in method development in relevant scientific journals, or presentations at industry conferences.