Associate Director, Biologics Analytical

SUMMARY/JOB PURPOSE:

The Associate Director manages QC activities and external analytical development across multiple CMC biologics areas to support the development and manufacturing of biological drug candidates. The incumbent utilizes their technical expertise in clinical QC and analytical development such as batch release testing, stability management, method development, laboratory deviation investigation, and change control 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:

• Responsible for the QC batch release data review following Exelixis standard; work closely with QA to support the batch release and CoA issuance on product intermediates, DS, and DP lots

• The incumbent will interact with the contract development and manufacturing organization (CDMO) and control testing laboratories (CTL) to ensure the batch release and stability data are reported per the project timeline

• Manage the stability program for CMC biologics projects and build the internal process/system for stability data review and trending. Provide QC assessment on temperature excursion incidents from GMP material shipment and clinical sites

• Manage and / or support external analytical development at CROs and CDMOs

• Monitor and ensure an uninterrupted supply of assay reference standards, assay controls, and critical reagents for sample testing at CDMO/CTL sites. Work with the rest of the analytical team to plan and qualify new reference standard and reagent lots

• Manage the internal change control such as specification change and deviation investigation related to the analytical team.

• Manage sample shipments to internal and external sites

• Support the analytical development team to develop, qualify and validate the analytical methods at the CDMO/CTL sites

• Escalate significant issues to the group head and/or relevant project teams in a timely manner and drive the mitigation or problem-solving activities

• Analyze, interpret, present and document complex technical information such as development data or manufacturing and testing trends, in support of CMC objectives

• Support the IND/IMPD/BLA writing, or review based on the area of expertise

• Contribute to a broad range of technical objectives, such as troubleshooting urgent issues, proactive monitoring and analysis of ongoing manufacturing/testing, product development strategy, and longer-term development efforts.

• Adjust and align the roles and responsibilities across different functions as needed

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

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

• Master’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 9 years of relevant industry experience; or,

• Ph.D. in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 5 years of relevant industry experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Demonstrated experience in QC technical support of clinical or commercial biological products. This includes but is not limited to the GMP method performance monitoring and troubleshooting, laboratory event investigation, reference standard, critical reagent management, stability data management and trending, instrument qualification, change control, specification, and CoA issuance.

• Analytical testing, validation, or transfer experience in a wide range of QC methods such as cell-based assays, ELISA, residual HCP, qPCR, HPLC, CE, color, clarity, visible particles, A280, and QC microbiology methods such as sterility, bioburden, and endotoxin.

• Experience in analytical method development, method qualification, method validation for biologics including HPLC, CE and mass spectrometry-based methods.

• Experience in developing and applying mass spectrometry-base