Director / Senior Director of CMC

Company Overview:

Our current pipeline includes immuno-oncology candidates against both solid and hematological tumors as well as medicines and vaccines for several of the world's most pressing viral threats. Our founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients.

External Description:

We are seeking an experienced and highly motivated Director / Senior Director of CMC. This role is pivotal in ensuring the seamless progression of our diverse pipeline of biologics candidates from Research to IND enabling work and through clinical development.

Key Responsibilities:

• CMC Technical Leadership: Develop and implement comprehensive CMC strategies and oversee CMC activities for assigned projects, including biologics and lipid-based delivery modalities, ensuring alignment with regulatory standards and company objectives. Present plans and updates to senior leadership and external stakeholders.
• CDMO Management: Oversee execution of CMC work at CDMO network worldwide from cell line development to bulk drug substance, drug product manufacturing, shelf life and readiness for clinical supply. Ensure timeline delivery of high-quality Drug Substances and Drug Products for nonclinical studies and clinical trials.
• Regulatory Submissions: Prepare and/or review CMC sections of regulatory submissions including background documents, INDs, IMPDs, ensuring compliance with regulatory requirements and guidelines.
• Cross-Functional Collaboration: Work collaboratively with Research, Clinical Development, Regulatory Affairs, and other departments to ensure cohesive advancement of projects. Establish and maintain high-quality, collaborating closely with Quality Assurance to ensure adherence to GMP and ICH guidelines.

Qualifications:

• Advanced degree (Ph.D. or M.S.) in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• Minimum of 10 years of experience in CMC roles within the biotechnology or biopharmaceutical industry.
• Demonstrated experience as a CMC technical lead with hands-on experience managing CDMOs.
• Strong technical background in biologics process development and/or manufacturing operations.
• In-depth knowledge of global regulatory requirements, GMP, and ICH guidelines.
• Exceptional problem-solving skills, strategic thinking, and the ability to operate effectively in a dynamic, fast-paced environment.
• Strong technical writing and communication skills and experience presenting to internal and external stakeholders at all levels.

ModeX Therapeutics is an Equal Opportunity Employer