Associate Director, Drug Product, CMC

🕒 Abril 7

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BBOT

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

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

• At least 5 years of lab-based experience specifically in small molecule drug product development. • Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field with 8+ years of relevant industry experience OR M.S. with 12+ years of relevant industry experience. • Specific experience in Pivotal drug product development, registration batches, validation or commercial. • Experience with Quality by Design (QbD) and Design of Experiments (DoE) for selection and optimization of drug product. • Experience in developing BCS Class II/IV drugs. • Experience directly managing CDMOs and overseeing external development and manufacturing. • Tech transfer and scale up experience of drug product manufacturing processes.

🏖️ Benefícios

• annual bonus • stock-based long-term incentives • medical, dental, and vision benefits • retirement • wellness stipend • flexible time off