Associate Director, Engineering

Job Description

Associate Director, Engineering within Biologics External Manufacturing Technology

Due to continued growth and investment, our company is hiring an Associate Director, Engineering within Biologics External Manufacturing Technology. The Associate Director will be the key technical leader and interface between our company and external partners for the Biologics External Manufacturing (ExM) organization.

This individual will create, lead and execute technical transfers to and commercial supply from external partner(s). The candidate will be based in the US on the west coast and report to the Director, Biologics External Manufacturing Technology.

The ideal candidate will be able to navigate a complex network of drug substance nodes across biologics modalities and tech support models, collaborate with multiple technical functions, and provide significant leadership to the department. This role is critical to supporting new and in‑line commercial product technology transfers to external partnerships and maintaining our in‑line products.

Accountable for achieving excellence in compliance, supply, continuous improvement, and cost reduction in partnership with internal technical partners and external partner (EP) leadership, supporting the Vaccines and Biologics businesses.

Works in collaboration with Focus Factory Operations lead, modality specific technology leads, Large Molecule External Quality Assurance, and Procurement.

Must have biologics manufacturing experience, broad process sciences and analytics, strong leadership skills, business acumen, and interpersonal skills.

• Provides a single point of technical contact to assigned EP, impacted Company Manufacturing Division sites, and Commercialization.
• Provides technical oversight, management, and planning support for complex partnership models; coordinates communication and oversight of EP technical issues.
• Accountable to EP for overall tech transfer delivery (on‑time, within budget), working closely with Operations Unit leadership to assure resourcing.
• Provides technical guidance to EP, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound.
• Collaborates with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate EP(s) for inclusion in the Company Network and executes technical due diligence assessments.
• Ensures tech transfers are positioned for successful business outcomes and executes receiving site readiness activities.
• Leads team for identification and assessment of partner risks and develops mitigation plans.
• Develops and executes validation strategies for new and existing products.
• Provides manufacturing process support to EP to resolve production issues and optimize process and capacity.
• Ensures targeted communications and alignment across technical functions; guides and coaches others in change leadership.
• Supports, coordinates, and manages complex investigations, interfacing with other impacted manufacturing sites.
• Determines resource plans across all relevant technical functions.
• Provides technical review of EP process change requests, deviations, and Master Batch Record changes; minimizes duplication of efforts between EP and Company systems.
• Drives continuous process verification and process performance monitoring for all products under responsibility.
• In concert with Commercialization, Quality, and Regulatory, ensures EP are inspection ready for all new product introductions and transfers.
• Understands regulatory requirements and partners with Operations, Quality, and EP to develop more efficient ways to meet them.
• Collaborates with EP to achieve business goals and to establish a common culture that benefits both the Company and EP.

• At least a Bachelor’s degree in Engineering or applicable Science; advanced degree preferred.
• Minimum of 8 years post‑bachelor’s experience in drug substance or product vaccines and/or biologics manufacturing, engineering, or technical support operations.

• Expertise and accomplishments…