Associate Director, MFG Sciences, Downstream Process Technology

About This Role:
As the Associate Director of Manufacturing Sciences, Downstream Process Technology, you will lead a team of technical experts responsible for the Drug Substance Large Molecule Downstream manufacturing at our site. Your role is pivotal in providing scientific leadership and technical support for both new and existing manufacturing processes. You will oversee process transfers, manage laboratory studies, and ensure the seamless transition of processes into commercial operations. Collaborating with various site and global technical functions, you will support commercial manufacturing campaigns and lead the resolution of process deviations. Your contributions will enhance our manufacturing capabilities, ensuring product quality and regulatory compliance. This position is integral to the Global Manufacturing Sciences team, reporting directly to the Head of Manufacturing Sciences.

What You’ll Do:

• Lead and guide technical teams providing technical expertise and laboratory oversight across technology transfer, manufacturing operations, process lifecycle management, and continuous improvement initiatives.
• Manage, develop, and coach team members to enhance performance, build technical capability, and ensure alignment with strategic and operational objectives.
• Lead cross‑functional technology transfer teams from new product introduction through process qualification and commercial implementation.
• Provide technical oversight and support for clinical, PPQ, and commercial manufacturing operations to ensure robust and compliant processes.
• Collaborate on cross‑functional initiatives with site and global stakeholders, including operations, quality, development, and product technical peers.
• Investigate process deviations, define and implement corrective and preventive actions (CAPAs), and verify effectiveness through structured follow‑up and monitoring.
• Own and maintain process control strategies and documentation; author and review process validation documentation and own Global Change Controls (GCCs).
• Support regulatory audits and internal quality reviews.
• Perform Continued Process Verification (CPV) trending and advanced data analysis to assess process performance and drive optimization.

Who You Are:
You are a natural leader with a passion for driving innovation and process excellence. Your strong communication skills enable you to effectively share project updates and align team efforts with strategic goals. You thrive in collaborative environments and excel at guiding technical teams in complex problem-solving. Your dedication to continuous improvement and quality assurance makes you an invaluable asset to our manufacturing sciences team.

Required Skills:

• A minimum of 10 years’ experience with a B.S., 8 years with an M.S., or 5 years with a Ph.D. in a relevant field.
• Extensive experience in downstream process technology and manufacturing sciences.
• Strong leadership and team management skills.
• Excellent communication and collaboration abilities.
• Proven track record in process improvement and technology transfer.

Preferred Skills:

• Experience with regulatory audits and quality assurance processes.
• Proficiency in authoring technical reports and regulatory documents.
• Familiarity with process trending and data analysis for process improvements.

 

Job Level: Management