CMC Manager, Drug Substance

CMC Manager, Drug Substance

Location: Onsite - Menlo Park, CA, Miami, FL, Princeton, NJ or Oxford, UK

Overview of Role:

The CMC Manager, Drug Substance will play a crucial role in supporting the Director, CMC, Drug Substance. This position involves managing and overseeing the Chemistry, Manufacturing, and Controls (CMC) activities related to drug substance development and production. Experience with drug product would be beneficial. The CMC Manager will work closely with various departments to ensure the successful execution of CMC projects, maintain compliance with regulatory requirements, and support the overall drug development process. Experience in CMC biologics is essential, and experience in late-stage clinical and commercial phases is preferable. This role will report to the Director CMC, Drug Substance. All drug manufacturing is outsourced.

Role and Responsibilities:

• Support the Director, CMC, Drug Substance in managing and overseeing all CMC activities related to drug substance development and production.
• Assist in managing outsourcing of manufacturing activities, including working with Contract Development and Manufacturing Organizations (CDMOs).
• Collaborate with internal teams and external partners to ensure timely and efficient execution of CMC projects.
• Assist in developing and implementing CMC strategies to support drug development and regulatory submissions.
• Review and approve CMC documentation, such as development protocols, reports, batch records, and regulatory submissions.
• Ensure compliance with GMP, ICH, EMA, and FDA regulations throughout the CMC process.
• Work closely with Quality Assurance, Regulatory Affairs Supply Chain, and other departments to ensure alignment and successful project outcomes.
• Monitor and manage project timelines, budgets, and resources to ensure project goals are met.
• Identify and mitigate risks associated with CMC activities and develop contingency plans as needed.
• Provide technical expertise and guidance to the CMC team and other stakeholders.
• Assist in the data analysis of manufacturing, clinical, and commercial data to support ongoing processes.
• Support the planning and budgeting activities in collaboration with the Director, CMC, Drug Substance.
• Ensure quality standards are met throughout the CMC process and support quality assurance activities.
• Collaborate with the Quality Assurance team to address any quality-related issues and implement corrective actions.
• Work closely with the supply chain department to ensure seamless coordination and integration of CMC activities with supply chain operations.
• All other duties as assigned.

Experience, Education and Specialized Knowledge and Skills:

• Degree in Biotechnology, Chemistry, Biochemistry, Biochemical/Chemical Engineering, or a related field. Advanced degree preferred.
• A minimum of 5 years of proven experience in the biotechnology or pharmaceutical industry, specifically focusing on CMC activities in biologics. Experience with CMC biologics is essential.
• Strong understanding of drug substance development, process development, and manufacturing. Understanding of drug product manufacturing would be beneficial.
• Experience in late-stage clinical and commercial phases is preferable.
• Demonstrated expertise in regulatory submissions and compliance with GMP, ICH, EMA, and FDA regulations.
• Understanding of quality assurance and maintaining quality standards throughout the CMC process.
• Excellent project management skills, with the ability to manage multiple projects simultaneously.
• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
• Ability to travel as needed for business purposes.