Director/ Sr Director, CMC Drug Product Development
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.
- 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.
- 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.
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