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JOB DESCRIPTION

Reporting to the Chief Scientific Officer, as the Director/ Sr Director, CMC Drug Product Development, you will serve as the CMC discipline lead and foundationally, you will be an expert in CMC drug product development and formulation.

RESPONSIBILITIES

• Develop company-wide Chemistry, Manufacturing and Control (CMC) strategies and plans related to Auron’s lead programs as they progress towards IND and beyond.
• Plan, perform and lead various stages of drug product development, including pre-formulation, solid form and formulation development, analytical, process development, optimization, scale-up studies.
• Provide technical, functional, and leadership on drug product development and CRO/ CDMO management.
• Manage outsourced Formulation R&D and drug product development and oversee drug substance strategy in conjunction with external consultants and vendors.
• Work collaboratively with discovery chemistry, toxicology, pharmacology, and clinical development to develop and deliver drug products for all phases of preclinical and clinical development.
• Author, review and oversee technical documents, formulation development reports, and drug substance and drug product sections for INDs.

Requirements:

• in Pharmaceutical Sciences, Chemistry, or related discipline, with 10+ years of experience, or Master’s with equivalent experience.
• Significant experience managing CROs, CDMOs and external vendors and delivering on challenging timelines.
• Excellent scientific knowledge in pre-formulation, solid form, formulation development and analytical development.
• A track record of successful development of intravenous and solid oral dosage forms and enabled formulations is highly desired.
• Thorough understanding and working experience in drug product development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
• Experience authoring and reviewing technical documents including, but not limited to development reports, master batch records, analytical testing methods, and specifications.
• Experience in drafting drug product and substance sections of INDs and practiced in responding to inquiries from regulatory agency review.
• Strong problem-solving skills with strategic and sound technically driven decision-making ability.
• Effective written and verbal communication skills and interpersonal skills.
• Innovative team player with high energy for a dynamic company environment.