Associate Director, Drug Product, CMC

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BBOT

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51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

BBOT ist ein Biotechnologieunternehmen, das gezielte Therapien für durch RAS-Signale und PI3Kα verursachte Krebsarten entwickelt. Das Unternehmen konzentriert sich auf rationales Wirkstoffdesign, um den aktiven ON-Zustand von RAS zu hemmen und die RAS-getriebene PI3K-Aktivierung selektiv zu blockieren, zielt auf mehrere KRAS-Mutanten und neuartige Ansätze zur Maximierung der Zielinhibition. BBOT übersetzt jahrzehntelange Forschung zur RAS-Biologie in therapeutische Kandidaten, die zur Verbesserung der Ergebnisse für Patienten mit RAS- und PI3Kα-gesteuerten Tumoren bestimmt sind.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

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