Associate Director, Engineering

This is a fully remote position, open to applicants in China.

📋 Description

• Serve as the lead and primary point of contact for technical matters between technical operations and external partners.

• Offer technical leadership for the commercialization and production of drug substances.

• Deliver technical guidance to external partners while evaluating proposed process configurations and adherence to standards.

• Collaborate with procurement, external manufacturing operations, external quality, regulatory, and other teams to assess external partners.

• Carry out technical due diligence evaluations at external partner sites.

• Implement technical transfers and ensure readiness activities at receiving sites.

• Identify and evaluate partner risks, developing mitigation strategies as necessary.

• Execute validation strategies for both new and existing products.

• Assist external partners in troubleshooting production challenges and enhancing processes and capacities.

• Support, coordinate, and manage intricate investigations.

• Review process change requests, deviations, and modifications to master batch records from external partners.

• Promote continuous process verification and monitor process performance for designated products.

• Collaborate with operations, quality, and external partners to efficiently meet regulatory requirements.

• Aid in external large molecule drug substance manufacturing activities throughout the external manufacturing network.

⛳️ Requirements

• A Bachelor’s degree in engineering, biological or chemistry sciences, or a related field.

• At least 10 years of pertinent experience in manufacturing, including process start-up, routine manufacturing, and/or technical transfer.

• A minimum of 5 years of experience in Drug Substance, particularly in leading Drug Substance Technical Transfers and/or commercial manufacturing.

• Proven ability to work effectively across various boundaries and establish collaborative relationships with internal teams and external partners.

• Strong professional and interpersonal communication abilities.

• Authentic and inclusive leadership skills, with the capability to engage others and foster a psychologically safe, collaborative environment.

• Ability to manage multiple tasks and work under tight deadlines.

• Familiarity with change control procedures and relevant systems.

• Capacity to work independently complemented by excellent organizational skills.

• In-depth understanding of Quality systems, Drug Substance Manufacturing, and Validation processes.

• Proficient analytical problem-solving skills, including root cause analysis and risk assessment/mitigation capabilities.

• Excellent command of English, both written and spoken.

• Experience in mAb DS production is preferred.

• Familiarity with conjugation processes is preferred.

• Lean Manufacturing / Six Sigma experience is preferred.

• Project management experience is preferred.

• Awareness of global regulatory requirements and experience in supporting regulatory inspections is preferred.

🏝️ Benefits

• Remote work arrangement available.

• No relocation assistance provided.

• Travel requirements include periodic travel of 10–20% as outlined in the role description.

• Temporary (Fixed Term) employee status.