Associate Director, Technical Operations, Small Molecule Drug Substance

What you'll do

• Provide technical leadership and oversight for API manufacturing processes including chemical synthesis, purification, crystallization, and drying.
• Lead process scale-up, technology transfer, and validation activities for assigned products across internal sites and external partners.
• Support capital projects through design, commissioning, qualification, and facility startup phases to ensure readiness for commercial production.
• Drive continuous improvement initiatives to enhance process performance, yield, robustness, and impurity control.
• Lead investigation of manufacturing deviations, out-of-specification results, and CAPA actions using root cause analysis.
• Ensure all manufacturing processes comply with cGMP standards and regulatory requirements during audits and inspections.
• Manage a team of technical specialists and engineers through coaching, performance feedback, and resource planning.

What we're looking for

• Hold a Bachelor’s, Master’s, or higher degree in Chemistry, Chemical Engineering, or a related discipline.
• Possess at least 10 years of experience in API process development and/or manufacturing.
• Demonstrate a strong background in process chemistry and scale-up.
• Possess expertise in process, equipment, and cleaning validation.
• Maintain working knowledge of cGMP manufacturing operations and regulatory inspection readiness.
• Experience with deviation management, investigations, and electronic batch records is required.
• Exposure to capital projects, CQV, and facility startup is required.
• Must possess strong analytical, problem-solving, and communication skills to work across cross-functional teams.