Senior Associate Engineer II, Supply Chain & External Manufacturing

Position Overview

We are seeking a talented Senior Associate Engineer II for the Supply Chain and External Manufacturing organization to serve as a primary point of contact for key external partners and support non-clinical development and CMC/manufacturing across Technology, Development & Operations (TDO). This includes relationship and project management for CDMOs, CTLs, CROs and other critical suppliers.

The role is focused on defining clear scopes of work, negotiating and managing SOWs/SOCs and change orders, proactively planning and managing risk, and ensuring tight alignment between internal teams and external partners. The ideal candidate is a highly creative and collaborative engineer with excellent project management skills, a roll-up-your-sleeve and solution-oriented attitude who is comfortable learning new things, wearing multiple hats, and operating in a fast-paced, evolving environment.

This role reports to the Director of Supply Chain and External Manufacturing. The ideal candidate will be onsite 5 days/week.

Key Responsibilities

External Partnership, Relationship Management and Logistics

• Serve as the primary point of contact and project manager for assigned CDMO, CTL, CRO and other external partners across both non-clinical and CMC projects and activities. The position will be responsible for coordinating communications between technical experts and external partners, prioritizing and facilitating external project team meetings.
• Establish and run effective meetings with partners and ensure timely communication and resolution of issues
• Coordinate with logistics providers and partners on shipment of materials, intermediates, and finished products between and external sites ensuring compliance with relevant shipping and regulatory requirements (permits, customs, chain of custody, temperature control).
• Build strong, trust-based relationships and drive continuous improvement in performance and ways of working.

Internal Alignment, Scope Definition, Financial Management & Communications

• Collaborate with stakeholders in Non-Clinical Development, CMC/Manufacturing and Quality, Program Management, Finance, Legal and others to align on objectives, expectations and priorities for external work.
• Translate program strategies into clear, actionable SOWs/SOCs with defined deliverables, timelines, and roles/responsibilities.
• Collaborate with Legal, Finance, Procurement and technical SMEs on MSAs, Quality/Technical Agreements, SOWs/SOCs and amendments.
• Own the operational aspects of SOW/SOC and change-order management
• Support budget tracking and financial planning for assigned vendors (forecasts, accrual inputs, and cost/risk trade-offs).
• Keep internal and external teams aligned as plans evolve with clear and concise documentation, as well as facilitating cross-functional meetings focused on execution and decision-making.

Project Management, Planning & Risk Management, Process and Tools

• Develop and maintain integrated project plans for external workstreams aligned with overall program timelines and decision points.
• Monitor progress against milestones and KPIs and drive accountability to keep work on track.
• Develop and use dashboards and reporting to improve visibility into vendor performance, contract status, risks and key milestones.
• Proactively identify risks and dependencies, propose mitigation options, and maintain risk/issue/action logs.
• Embrace the use of AI and other digital tools to streamline workflows, improve decision-making, and accelerate execution
• Use LEAN and Six Sigma methodologies to develop and improve business processes
• Additional duties as assigned

Qualifications

• BS/MS degree in Life Sciences, Chemistry, Engineering, Supply Chain, Business or related discipline; a background in STEM is preferred
• 4 - 6 years of relevant industrial experience in biotechnology, pharmaceuticals, or cell and gene therapy, with significant exposure to non-clinical development and/or CMC/manufacturing.
• Direct experience managing external partners (e.g., CDMOs, CTLs, CROs), including project execution, relationship management, and issue resolution.
• Demonstrated experience with contracts, SOWs/SOCs and change orders, working closely with Legal, Finance and technical teams.
• Strong project management skills including planning, prioritization, tracking, and cross-functional coordination in a fast-paced, evolving environment.
• Familiarity with GxP environments and advanced therapy modalities (e.g., CGT) is strongly preferred.
• Fluent in the use of digital and AI-based tools to manage projects, data and documentation, with an interest in learning and experimenting with new tools as they evolve.
• A hands-on, “just roll up the sleeves” mindset that keeps programs and partnerships moving forward
• Excellent verbal and written communication skills; able to influence and align diverse stakeholders without formal authority.