Day One Biopharmaceuticals is hiring a
Director, Analytical Development

Summary

Join our team as a strategic and technical leader to build and lead both the biologics and small molecule analytical development and quality control function in support of our Tovorafenib commercial product and pipeline of ADC novel therapies.

Requirements

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field with 10+ years of BioPharma experience leading analytical development and QC of both large and small molecules within a CMC department
• B.S or M.S in relevant field with 15+ years of BioPharma experience leading analytical development and QC of both large and small molecules within a CMC department
• Demonstrated experience managing internal and external teams
• Experience in Analytical Development, QC, and Global external laboratory oversight strongly preferred
• Expertise in developing and validating phase appropriate analytical methods for both biologic and small molecules in early and late-stage product development
• Significant experience interfacing with and providing effective oversight of analytical and QC operations at CDMOs
• Deep and broad knowledge of analytical chemistry of biologics in support of drug substance and drug product release and stability method development, raw material control, in process control, and characterization

Responsibilities

• Lead and oversee the analytical development & QC function in developing robust phase-appropriate analytical methods for characterization and release of intermediates, active pharmaceutical ingredients, and drug product candidates in the pipeline
• Lead and oversee analytical development in designing and developing robust phase-appropriate analytical methods for characterization and routine testing of materials
• Execute the overall analytical development control strategy throughout development with robust analytical and biological methods for the characterization of starting materials, intermediates, products, and known/potential impurities
• Guide critical quality attribute, specification, and control strategy development
• Define product specifications and strategy for harmonization of specifications across global clinical and commercial supply chains
• QC check CDMO generated raw data
• Oversee characterization and control of reference standards, Track and trend stability data for ongoing studies
• Independently and/or as part of a team, identify impurities and degradation products
• Leadership in the selection of CDMOs and contract laboratories for non-GMP/GMP development and manufacturing
• Ensure phase appropriate method qualification and testing activities for biologic/small molecule products are available at qualified vendors
• Oversee all analytical based activities at CDMOs by providing analytical development and testing guidance to ensure all analytical methodologies are robust and in compliance
• Manage investigational testing and assist with deviations/investigations/CAPA’s as they pertain to both internal and external CDMOs quality management systems
• Manage proposals and contracts for CDMOs
• Collaborate with cross-functional teams, including Process Chemistry, Formulation Development, mAb production, QA, and Regulatory, to ensure alignment of analytical methods and controls with overall project goals
• In conjunction with other CMC members and QA, communicate product quality risks at all stages of development
• Implement and maintain analytical testing procedures in compliance with regulatory requirements based on relevant guidance and accepted standard organizations (e.g., USP, EP, JP, etc.)
• Work closely with regulatory CMC to ensure that analytical methods and specifications meet all regulatory guidelines and are properly represented in regulatory filings
• Author/review for IND, BLA, and other regulatory submissions to include all relevant analytical data and documentation in support of clinical/commercial products

Benefits

The salary range for this position is $200,00 - $230,000