Director, CMC – Formulations

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🕒 Maio 15

🏄 California – Remoto

🏄 California – Remote

💵 $190.000 - $260.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Codera

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🧬 Biotecnologia

💊 Farmacêutico

🤝 B2B

Biotechnology • Pharmaceuticals • B2B

A Codera é uma empresa B2B que faz parceria com empresas de biotecnologia e farmacêuticas para fornecer expertise e infraestrutura de desenvolvimento de medicamentos de ponta a ponta. Ela apoia clientes em todo o ciclo de vida do desenvolvimento de medicamentos com serviços técnicos, operacionais e infraestrutura para ajudar a avançar os programas terapêuticos.

Descrição

• Assist with the design and evaluation of drug product formulations, primarily small molecule formulations, to achieve specific pharmacokinetic (PK) goals • Contribute to CMC and development strategy • Manage relationships with various contract development and manufacturing organizations (CDMOs), analytical labs and contract research organizations (CROs) • Assist with the clinical supply logistics • Prepare, analyze and interpret analytical data that integrate into regulatory and intellectual property (IP) documents • Draft, edit and review sections of regulatory and IP documents • Provide scientific input for analytical protocols and study reports • Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence • Research CMC and formulation topics to support Tang Capital’s investments • Participate in business development activities, as requested

🎯 Requisitos

• Bachelor’s degree or higher in life sciences or related discipline required • Master’s degree preferred • Minimum of 5 years in relevant pharmaceutical industry work experience required • Experience with small molecule formulations required • Experience with biologics formulations preferred • Experience working with CDMOs and analytical labs • Experience with one or more of the following drug product formulation strategies: modified/delayed release, fixed-dose combinations, spray-dried dispersions • Experience with a wide range of excipients and formulation technologies • Experience with formulations for oral, subcutaneous and/or inhaled delivery • Ability to research, synthesize and summarize complex CMC topics • Experience writing and/or reviewing regulatory documents, including Investigational New Drug (IND)/New Drug Application (NDA) sections • Ability to effectively organize and manage multiple assignments with challenging timelines from project start-up through submission • Excellent knowledge of Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) regulations and Good Manufacturing Practices (GMP) • Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas • Ability to establish and maintain collaborative working relationships with internal and external stakeholders.

🏖️ Benefícios

• employer sponsored insurance plans including medical, dental and vision coverage • generous paid time off • retirement plan options • additional wellness and professional development programs