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 Director/Senior Director leadership role for the biologics program. The scope of the role encompasses mid to late stage antibody development and manufacturing.
- Lead DS and DP pharmaceutical development and manufacturing activities relating to the biologics program.
- Hire, develop, and manage direct reports and consultants.
- Manage budgets, contracts, and ensure timelines are well integrated with program goals.
- Build strong relationships with all CMO/CROs involved in the program.
- Provide both strategic leadership and exceptional operational support.
- Collaborate with research and development and G&A functions, to accomplish program goals.
- Serve on the project team, representing the function and aligning on priorities.
- Prepare regulatory CMC submissions, author SOPs and technical reports
- Ensure compliance with Syndax quality standards.
- 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 at least 10 years of biopharmaceutical manufacturing experience or MS with more than 15 years of relevant experience.
- Experienced in all aspects of antibody drug substance manufacturing and development.
- Experienced in advancing processes through clinical development to commercialization strongly preferred.
- 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 and sterile fill-finish.
- 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.