Head of CMC
Title: Head of CMC
Location: Waltham, MA
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.
Who We Are:
Palleon Pharmaceuticals is the leading biotechnology company developing drugs that target glycan-mediated immune regulation to treat cancer and inflammatory diseases. The company’s proprietary platforms integrate technologies and insights from global scientific leaders in the glyco-immunology field to overcome historical scientific hurdles and create novel therapeutics for devastating diseases characterized by immune system dysfunction. Palleon’s lead program in oncology, an enzymatic sialoglycan degrader, is expected to enter clinical testing in 2021. The company has several other drug discovery programs underway in disease areas where glycan-mediated immune regulation plays a role, including inflammatory diseases such as autoimmunity and fibrosis. Palleon was launched in 2015. The company recently raised a $100 million Series B financing from leading investors Matrix Capital Management, SR One, Pfizer Ventures, Vertex Ventures HC, Takeda Ventures, AbbVie Ventures and Surveyor Capital (a Citadel company). Learn more at www.palleonpharma.com.