At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. We are a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. We have an opening for a biologics drug substance Associate Director/Director. The scope of the role encompasses mid to late-stage antibody development and manufacturing activities including process characterization, validation, and regulatory submission writing.
The candidate will oversee the planning and execution of outsourced antibody drug substance development and manufacturing. They will define project scope in conjunction with CMO/CROs, ensure appropriate quality and regulatory requirements are met, and ensure that timelines and budgets are on track.
- Define and manage drug substance CMO activities. Build strong relationships with all CMO/CROs involved in the program.
- Review Master and Executed Batch Records, release testing data and stability data.
- Provide direct oversight and represent Syndax CMC as person-in-plant during certain critical manufacturing activities at participating CMO/CRO sites.
- Participate in designing comparability and characterization studies and review reports.
- Perform risk assessment for upstream and downstream activities; create and implement any remediation plans necessary.
- Apply a science and risk-based approach for addressing deviations, investigations, and process issues.
- Provide clear communication to functional group and project teams.
- Ph.D. and 10 years of biopharmaceutical manufacturing experience or MS with more than 10 years of relevant experience.
- Experienced in all aspects of antibody drug substance manufacturing and development including expression, upstream cell culture operations, downstream purification operations, process and analytical characterization, and process validation.
- Experienced in advancing processes through clinical development to commercialization.
- Demonstrated ability to work outside of the box and influence novel CMC and regulatory pathways to accelerate development.
- Knowledgeable and practiced with Single Use Bioreactors for GMP manufacturing.
- Excellent written and verbal communication.
- Demonstrated ability to work well in a fast-paced environment.
- Must be able to effectively manage multiple activities and problem-solve to achieve business needs.
- Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.
- Excellent planning and project management skills.
- Dynamic and energetic, hands on approach to challenges.
- Business travel to various CMO/CRO sites, company offices, suppliers, and partners as required.