Director, CMC Formulation Development and Manufacturing

About the role

IDEAYA is a precision medicine oncology company dedicated to discovering, developing, and commercializing transformative therapies for cancer. The Director, CMC Formulation Development and Manufacturing role is based in South San Francisco and involves collaboration with cross-functional teams to support the company's drug discovery pipeline.

Responsibilities

• Lead formulation efforts to facilitate drug development across all stages of development (pre-clinical, Phase I-III, and commercial)
• Author and review technical development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigations
• Develop and implement DP strategies to meet program and project development targets, ensuring timely and efficient delivery of high-quality products and regulatory approvals
• Represent DP/CMC and participate in cross-functional project teams, managing multiple priorities in a fast-paced environment and solving problems quickly
• Collaborate with cross-functional teams including Medicinal Chemistry, DMPK, Analytical Chemistry, Process Chemistry, Toxicology, Quality, Project Management, CMC Regulatory, Development Sciences, and Clinical Pharmacology to achieve project goals
• Oversee technology transfer activities at CDMOs to ensure successful manufacturing and provide technical expertise in troubleshooting and resolving issues as necessary
• Lead dosage form selection, formulation development, process optimization, and scale-up activities, ensuring robust, cost-effective, and scalable manufacturing processes
• Select, manage, and evaluate CDMOs for formulation and process development, and GMP manufacture

Requirements

• Ph.D. in Pharmaceutics, Chemistry, Chemical Engineering or related discipline with a minimum of 12 years of development experience, or M.S. with a minimum of 15 years of development experience
• Demonstrated success in delivering timely execution of DP and CMC activities ranging from preclinical to commercial
• Expertise in small molecule formulation development, scale-up, and manufacturing, and phase-appropriate control strategy and specification development
• Experience with analytical techniques for small molecules and oral solid dose products, including proficiency in UPLC/HPLC, dissolution, and solid-state characterization techniques such as DSC/TGA, PLM, XRPD, and laser diffraction PSD method
• Good understanding of physico-chemical properties of APIs, PK/PD correlation, and formulation development
• Strong understanding of Quality systems, including SOPs, manufacturing record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, Deviations, and Change Management
• Knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines, and USP-NF, Ph. Eur, BP, and JP compendia
• Experience in managing global CDMOs and reviewing documentation to ensure proper guidelines are followed
• Exceptional problem-solving skills and ability to quickly adapt and shift focus as needed
• Excellent interpersonal and communication skills for internal and external collaborations
• Ability to multi-task in a fast-paced dynamic environment while maintaining a calm and positive attitude and superior work ethic
• Able to travel domestically and internationally to oversee DP development and manufacturing at CDMOs

Qualifications

• Ph.D. in Pharmaceutics, Chemistry, Chemical Engineering or related discipline with a minimum of 12 years of development experience, or M.S. with a minimum of 15 years of development experience
• Pharmaceutical development experience in small molecule formulation development, scale-up, and manufacturing
• Experience with analytical techniques for small molecules and oral solid dose products, including proficiency in UPLC/HPLC, dissolution, and solid-state characterization techniques such as DSC/TGA, PLM, XRPD, and laser diffraction PSD method
• Understanding of physico-chemical properties of APIs, PK/PD correlation, and formulation development
• Strong understanding of Quality systems, including SOPs, manufacturing record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, Deviations, and Change Management
• Knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines, and USP-NF, Ph. Eur, BP, and JP compendia
• Experience in managing global CDMOs and reviewing documentation to ensure proper guidelines are followed

Skills

• Leadership in cross-functional teams
• Technical writing and reporting
• Project management and prioritization
• Collaboration with cross-functional teams
• Problem-solving and quick adaptation
• Interpersonal and communication skills
• Travel and international oversight

Benefits

• Competitive total rewards package including medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs
• Salary range: $215,000 - $266,000
• Flexible work arrangements, including work-from-home options
• COVID-19 vaccination requirement

Pay

$215,000 - $266,000

Schedule

Full time