Associate Director, Drug Product, CMC

🕒 Julho 28

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BBOT

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

BBOT é uma empresa de biotecnologia que desenvolve terapias direcionadas para cânceres impulsionados pelo sinal RAS e PI3Kα. A empresa foca em design racional de medicamentos para inibir o estado ativo de RAS e bloquear seletivamente a ativação de PI3K impulsionada por RAS, visando múltiplos mutantes KRAS e novas abordagens para maximizar a inibição do alvo. BBOT traduz décadas de pesquisa em biologia do RAS em candidatos terapêuticos destinados a melhorar os resultados para pacientes com tumores impulsionados por RAS e PI3Kα.

Descrição

• Lead the drug product development strategy for assigned small molecule programs, including solid oral dosage forms and other relevant formats • Design, review, and oversee formulation development, process development, and technology transfer activities • Develop phase-appropriate Clinical formulations with a view to overall program success on aggressive development timelines • Author, review, and approve key CMC documentation including development reports, batch records, and regulatory filings (INDs, IMPDs, NDAs, etc.) • Manage outsourced development and manufacturing activities at CDMOs, ensuring technical rigor, compliance, and timeline adherence • Collaborate with internal CMC stakeholders including Process Chemistry, Analytical Chemistry, Reg CMC, and Supply Chain • Collaborate effectively as needed with ex-CMC partners, including Clin Ops, Clin Pharm, Global Reg, Quality, DMPK and Tox • Provide technical leadership on drug product troubleshooting, risk assessments, and change controls • Ensure activities are compliant with GMP, ICH guidelines, and global regulatory requirements • Travel as needed (up to 20%) to support critical manufacturing campaigns and attend company gatherings

🎯 Requisitos

• Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field with 8+ years of relevant industry experience • M.S. with 12+ years of relevant industry experience • Demonstrated experience in drug product development across Clinical phases, with an emphasis on Pivotal development and commercial readiness • Experience managing CDMOs and overseeing external development and manufacturing • Hands-on experience in drug product development with formulation design and process optimization • Experience with scale up and understanding of potential impact on CQAs • Exceptional problem-solving, organizational, and communication skills • Experience in authoring and reviewing regulatory submissions

🏖️ Benefícios

• Competitive salary, benefits, and meaningful equity participation in a company entering the public market • Annual bonus • Stock-based long-term incentives • Medical, dental, and vision benefits • Retirement • Wellness stipend • Flexible time off