Associate Director – Engineering

Role Overview

• Lead and act as the primary interface on technical issues between technical operations and the external partner.
• Provide technical leadership for Tech Transfers and commercial manufacturing of ADC drug substance.
• Lead a high performing team of Technical Operations Engineers who are supporting tech transfers and commercial manufacturing of different ADC molecules.
• Provides technical guidance to the external partners, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound.
• Executes identification and assessment of partner risks and develops mitigation plans.
• Collaborates with procurement, external manufacturing operations, external quality, regulatory, and others to evaluate external partner(s) for inclusion in our company network.
• Executes technical due diligence assessments at external partner(s).
• Executes validation strategies for new and existing products.
• Provides manufacturing process support to external partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
• Supports/coordinates/manages complex investigations, with appropriate interface with other impacted manufacturing sites.
• Provides a technical review of external partner process change requests, deviations, and master batch record changes.
• Minimizes duplication of efforts between external partner and our systems.
• Drives and supports continuous process verification and process performance monitoring program for all products under his/her responsibility.
• Understands the true regulatory requirements and partners with operations, quality, and the external partner to develop more efficient ways to meet these requirements.

Requirements

• Minimum of 10 years of relevant work experience in manufacturing
• Minimum of 5 of experience in Bioconjugation/ADC DS manufacturing
• Experience in leading Technical Transfers and Commercial Manufacturing
• Proven people management experience with a focus on developing and coaching high performing teams
• Strong professional and interpersonal communication skills are required
• Must be able to multi-task and work within tight deadlines
• Flexibility and the ability to work independently as well as excellent organizational skills
• Extensive knowledge of Bioconjugation Chemistry, Quality systems, Drug Substance Manufacturing and Validation
• Strong analytical problem-solving skills, root cause analysis and risk assessment/mitigation
• Excellent command of English (both written and oral).

Benefits

• Flexible Work Arrangements