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Overview

The Principal Engineer, Manufacturing Technical Services, will provide expert technical and GMP support for contract manufacturing organizations (CMOs) responsible for commercial drug product supply. This role will establish and maintain robust technical partnerships with CMOs to ensure reliable, compliant, and efficient manufacturing of aseptically filled drug products.

Key Responsibilities

• Technology Transfer & Scale-Up: Lead due diligence, process scale-up, optimization, and technology transfer activities for new drug product manufacturing at CMOs.
• Process Design & Control: Define process control strategies by establishing robust unit operations and probing process design spaces to enable commercial-scale manufacture of siRNA drug products across multiple therapeutic areas.
• Commercial & Clinical Manufacturing Support: Provide technical leadership for late-stage clinical and commercial manufacturing activities. Resolve complex manufacturing issues while balancing Supply, Quality, and Regulatory requirements. Deliver on-the-floor support, assess deviations, scope change controls and CAPAs, and develop risk assessments.
• Data Analysis & Continuous Improvement: Implement routine process data trending and prepare quarterly management review presentations. Identify and execute continuous process improvement initiatives with a strong understanding of regulatory and business impacts.
• Process Validation & Product Launch: Develop process validation strategies and statistical sampling plans to demonstrate process control and compliance with GMP requirements.

Qualifications

• Bachelor's degree in Engineering with 11+ years, Master's with 8+ years, or Doctorate with 6+ years of relevant process development/engineering experience.
• Strong leadership in drug product technology transfer and scale-up for clinical and commercial manufacturing.
• Development or manufacturing sciences experience in sterile filtration, aseptic fill/finish, and/or formulation development is strongly preferred.
• Proficiency in Quality by Design (QbD), Design of Experiments (DoE), statistical process control (SPC), and complex data analysis.
• Familiarity with modeling and optimization tools (e.g., MATLAB, JMP) is a plus.
• Detail-oriented with strong problem-solving skills and ability to identify subtle trends in data.
• Comprehensive understanding of cGMP principles and regulatory requirements, including process, equipment, and facility validation.
• Ability to travel to domestic and international CMOs as needed.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.

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