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.

Essential Duties And Responsibilities:

• 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 characterization, 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

Supervisory Responsibilities:

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

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 13 years of relevant industry experience; or,

• Master’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 11 years of relevant industry experience; or,

• Ph.D. in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 8 years of relevant industry experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• 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 characterization, 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 later-stage analytical development, method bridging, commercial validation, BLA authoring, and review is a plus

• Experience in antibody-drug conjugates and bispecific antibodies is a plus

Knowledge/Skills:

• Broad and deep knowledge of CMC biologic