Principal Engineer, Manufacturing Technical Services

Alnylam Pharmaceuticals • Cambridge, MA

10h

About The Position

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.

Requirements

• 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.
• Comprehensive understanding of cGMP principles and regulatory requirements, including process, equipment, and facility validation.
• Ability to travel to domestic and international CMOs as needed.

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal