Senior Director CMC Leader
Location: Leuven
Job Type: Full-time
About Us: Onco3R is a dynamic and innovative biotech start-up company committed to transform the lives of patients with autoimmune diseases and cancer. We are seeking a strategic, hands-on CMC Leader to lead and execute our CMC activities across a growing pipeline of innovative therapeutics.
Scope of the job
The CMC leader is a key member of the development team and will be responsible for developing and implementing regulatory strategies as part of the optimal development of molecules in the Onco3R portfolio. This is an exciting opportunity to shape the regulatory function within a fast-paced, entrepreneurial biotech environment.
The ideal candidate will bring deep CMC expertise, strong leadership capabilities, and a proven track record of hands on experience in contributing to the development of molecules.
Key Responsibilities
CMC Strategy & Execution
Plan and lead CMC development activities across all projects within the Onco3R portfolio and ensure development and supply activities are executed according to an agreed strategy, SOPs, industry standards, regulations and guidelines.
Oversee process development, analytical method development, formulation, and technology transfer
Define and implement manufacturing plans to support IND/CTA submissions and clinical supply
Manufacturing Oversight
Select, manage, and oversee contract development and manufacturing organizations (CDMOs) for GMP manufacturing
Ensure on-time delivery of drug substance and drug product for clinical trials
Support scale-up activities and assess manufacturability for future commercial readiness
Regulatory & Quality Support
Lead CMC content generation for regulatory submissions (INDs, CTAs, amendments, and responses to health authority questions)
Partner with regulatory and quality functions to ensure compliance with global GMP and regulatory expectations
Support quality system development and participate in vendor audits where appropriate
Cross-Functional Collaboration
Collaborate with nonclinical, clinical and regulatory teams to align CMC activities with program goals
Provide technical leadership in cross-functional team meetings and represent CMC in governance forums
Job requirements
PhD in organic chemistry with a proven track record in a (CMC) pharmaceutical environment, with extensive experience in setting up and managing an external partner network (CRO, CDMO) in a global context.
Knowledge of ICH (International Council on Harmonisation), GMP (Good Manufacturing Practice) and other regulatory requirements applicable in the CMC development domain are a must.
The candidate should be an expert in chemical process research and development with demonstrated experience interacting with discovery colleagues in bringing new compounds from preclinical to clinical development with a focus on speed, quality and efficiency.
Strong knowledge in analytical development, driving analytical controls and stability strategy for projects in an external CRO/CDMO network.
A deep understanding of Drug Product development with the ability to ensure clinical supplies in alignment with clinical project plans
Hands-on experience in dossier development, regulatory submissions and interactions is a must have.
Benefits
Competitive salary and benefits package.
Opportunity to work in a fast-paced and innovative environment.
Opportunity to help shape the growth of the company.
How to Apply
Interested candidates should submit their resume to contact@onco3R.com