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Senior Director, Drug Product Development

2 months ago

Santa Clara, California, United States Bayside Solutions Full time
Job Summary

We are seeking a highly experienced Senior Director to lead our drug product development activities, including preclinical lead optimization, formulation and process development, clinical manufacturing, and commercialization. This role will be responsible for developing and executing the CMC strategy, providing technical and project leadership, and working with cross-functional stakeholders to ensure seamless execution of pharmaceutical drug product development and CMC activities.

Key Responsibilities
  • Lead drug product development activities from preclinical lead optimization to commercialization, including pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, process optimization, and process validation.
  • Develop and execute the CMC strategy, including designing and overseeing the execution of QbD and risk-based studies, as well as process development activities in preparation for registration, validation, and commercialization.
  • Author and review technical reports and CMC-related documents required for regulatory submissions, including IND/NDA/MAA filings.
  • Build and maintain a high-performing team to support the ongoing pipeline, including strategic and technical oversight of internal staff and Contract Manufacturing Organizations (CMOs).
  • Lead cross-functional CMC teams for assigned projects to ensure adequate development and execution of CMC plans/strategies.
  • Collaborate with cross-functional teams, including process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox, to meet CMC and program goals.
Requirements and Qualifications
  • PhD (minimum MSc) in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field.
  • 18+ years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise, leadership, and early and late-phase drug product development experience with small molecules.
  • Demonstrated strong project and cross-functional team leadership and people management skills.
  • Leadership experience in late-stage product development, scale-up, tech transfer, and process optimization of solid oral dosage and parenteral formulations is a plus.
  • Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
  • Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China.
  • Exceptional problem-solving skills with strategic and sound technically driven decision-making ability.
  • Excellent written and verbal communication skills and interpersonal skills.
  • Innovative team player with high energy for our dynamic company environment.