Director, Biologics Analytical Development; CMC Biologics

SUMMARY/JOB PURPOSE

The Director, Analytical Development manages the analytical activities across multiple CMC biologics areas to support the development and manufacturing of biological drug candidates at external sites. The incumbent utilizes his/her technical expertise in CMC analytical areas such as method development, qualification, and specification setting to advance CMC development and manufacturing for pre‑IND and in‑clinic biological molecules. Strong ownership is critical to ensure the speed, cost‑effectiveness, and technical quality of our CMC activities.

The individual works independently and in cross‑functional teams and works effectively with third‑party CDMOs and partners.

• Build and lead an analytical team responsible for the analytical activities at external contract development and manufacturing organization (CDMO) and control testing laboratories (CTL) for biologics CMC product development.
• Own one or more projects with hands‑on responsibility as the analytical point of contact in the interaction with CDMO/CTL.
• Take ultimate accountability for the team's success on the assigned projects to set up the phase‑appropriate analytical programs per the project timelines. This includes analytical method development, qualification, validation, reference standard qualification, stability setup, specification, analytical comparability, product characterisation, etc.
• Provide analytical support to the process development and manufacturing team on the process development activities at CDMO sites.
• Build a process to ensure a seamless handover of the routine GMP testing and batch release review responsibility to the QC Operation team after the CDMO/CTL is set up for GMP testing. Support QC in the communication with CDMO/CTL to align the Exelixis change control and deviation investigation activities.
• Guide direct reports on various technical issues. Monitor the team performance and dynamics and provide feedback as needed.
• Escalate significant issues from the responsible team to the group head and/or relevant project teams in a timely manner and drive the mitigation or problem‑solving activities.
• Build collaborative relationships with other stakeholders including DS and DP Manufacturing, Process Development, Project Manager, Quality Assurance, and Regulatory Affairs.
• Adjust and align the roles and responsibilities across different functions as needed.
• Support the IND/IMPD writing, review, and regulatory responses.
• Contribute to a broad range of technical objectives, such as troubleshooting urgent issues, proactive monitoring and analysis of ongoing manufacturing/testing, late‑stage product development strategy, and longer‑term development efforts.

• Hire, train, and manage new members of the responsible analytical team.

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 13 years of relevant industry experience.
• Master's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 11 years of relevant industry experience.
• Ph.D. in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 8 years of relevant industry experience.
• Equivalent combination of education and experience.

• Demonstrated experience in managing the CDMO/CTL for clinical or commercial biological products.
• Extensive experience in outsourcing the analytical method development, transfer and qualification, product characterisation, stability, and cGMP initiation activities for biological IND projects.
• In‑depth experience in a wide range of batch release methods such as cell‑based assays, ELISA, residual HCP, qPCR, HPLC, CE, appearance, A280, chemical impurities, excipients test, etc. Experience in QC microbiology methods such as sterility, bioburden, endotoxin, and environmental monitoring is a plus.
• Demonstrated experience in people management, conflict resolution, and building consensus.
• Experience in…