Palleon Pharmaceuticals is seeking a Sr. Director of CMC to lead and execute the CMC development of drug substances and drug products from pre-clinical studies through clinical development. He/She will be responsible for all aspects of CMC activities to advance Palleon’s lead program, Sialidase-Fc, a first-in-class enzymatic sialoglycan degrader to treat cancer. The successful candidate will have a demonstrated track record of technical and project leadership of CMC development programs that deliver biological products to the clinic. This is an excellent opportunity for a highly motivated self-starter and creative problem solver who has a strong desire to make an important contribution to the development of novel biologics. This is a high profile, leadership position with the opportunity to innovate in an entrepreneurial and high growth organization.
- Lead CMC activities from pre-IND through early and late stage clinical development.
- Manage and oversee Contract Development and Manufacturing Organizations (CDMOs) for process development, GMP manufacture, and supply of drug product (DP) in support of clinical programs.
- Coordinate and monitor progress to ensure quality and timelines.
- Guide external operations including technology transfer, process and method development, optimization, qualification and validation of all activities related to CMC operations.
- Review CDMO documents, including technical reports, master and executed batch records, protocols, change controls, and documents related to supply chain and logistics in support of clinical studies.
- Prepare CMC regulatory filings.
- Participate in regulatory strategy development, regulatory filings, and meetings with regulatory agencies.
- Maintain an up-to-date understanding of all applicable regulations and industry standards for the development of biological products.
- PhD or MS in engineering, biochemistry, or a relevant discipline with 15+ years of experience in the biotech/pharmaceutical industry, and experience in all stages of biologics CMC development.
- Experience in managing CMC activities and projects with respect to science, technology, quality, and regulatory requirements.
- Knowledge of CMC development of enzymes, fusion proteins, bispecifics, or mAbs from the pre-clinical phase, through the clinical stage, to commercialization.
- Subject matter expertise in one or more CMC functional areas (process development, drug product, analytical).
- Solid understanding of cGMP and FDA regulations and guidelines related to CMC, and experience in the preparation of CMC regulatory filings.
- Proficiency in analysis of scientific data and results with the ability to review scientific documents including reports, publications and regulatory submissions.
- Strong problem solving and risk-based decision-making skills, and a strong ability to influence or manage without having direct authority.
- Highly developed interpersonal and communication skills.