Director, DP Workstream Leader – Small Molecule Parenteral (LAIs and Oligos)

Key Responsibilities

• Lead late stage development for New Chemical Entities drug products, from formulation to presentation and device design/development.
  • Specifically lead Small Molecule programs for parenteral (e.g. Long Acting Injectables), and/or for new modalities (Oligonucleotides).
  • Lead process development & scale-up and technology transfer of drug product processes to manufacturing and packaging sites, ensuring robust and efficient production, including internal facilities and Contract Manufacturing Organizations (CMOs), as required.
  • Oversee formulation and fill-finish process development, ensuring stability, compatibility, manufacturability, and product quality across clinical and commercial phases.
  • Carefully coordinate clinical and commercial supply readiness by aligning R&D, manufacturing, and supply chain activities, translating clinical and regulatory strategies into actionable technical deliverables, and building robust control strategies via cross-functional partnership.
• Strategically align CMC and workstream strategies with program objectives, translating project priorities into clear functional direction and deliverables influencing other functions as required to deliver integrated solutions.
• Act as the strategic interface between the CMC project and the function, ensuring technical excellence, operational readiness, and end-to-end delivery of CMC deliverables and Product Quality Deliverables (PQDs).
• Risk and Compliance: Anticipate and mitigate risks across quality, supply, and compliance dimensions, maintaining business continuity and regulatory robustness.
• Regulatory Excellence: Provide authoritative functional input to CMC regulatory submissions and ensure alignment with global standards, policies, and best practices to develop and file a robust control strategy.
• Cross-Functional Influence: Collaborate effectively across internal and external partners, driving alignment, accountability, and timely decision-making within a complex matrix environment.
• Technical Thought Leadership: Demonstrate scientific and operational leadership to elevate standards, streamline execution, and enable continuous improvement across the portfolio.
• Critical thinking: Apply critical thinking to assess the validity of arguments and data, form well-reasoned opinions, and challenge potential biases at all project levels to drive superior solutions.

Basic Qualification

• Bachelor’s degree in Chemical/Biochemical Engineering, Chemistry, Biology, or related science discipline.
• 8 or more years of experience in leading cross-functional projects and matrix teams representing a transversal or functional CMC development team at one or more project team levels within the pharmaceutical or biotechnology industries.
• 8 or more years of experience driving and executing on project strategies and the 360° aspects of medicine development, specifically for new chemical entities, their formulation and presentation.

PREFERRED QUALIFICATION

• PhD in Chemical/Biochemical Engineering, Pharmaceutics, Chemistry, Biology, or related scientific discipline.
• Experience with successful filing and approval.
• Experience in late stage development of small molecule drug candidates for parenteral long-acting injectables and/or oligonucleotides.
• Demonstrated record of scientific achievement and a broad and integrated knowledge of the field.
• Understanding of relevant regulatory and compliance standards.