Alnylam Pharmaceuticals · 3 days ago
Principal Engineer, Manufacturing Technical Services
Cambridge, MA
Contract
Hybrid
Senior Level, Lead/Staff
6+ years expAlnylam Pharmaceuticals is a leader in RNA interference therapeutics, dedicated to transforming the lives of patients with rare diseases. The Principal Engineer will provide expert technical and GMP support for contract manufacturing organizations, ensuring reliable and compliant manufacturing of drug products while leading various technical initiatives.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Lead due diligence, process scale-up, optimization, and technology transfer activities for new drug product manufacturing at CMOs
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
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
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
Develop process validation strategies and statistical sampling plans to demonstrate process control and compliance with GMP requirements
Qualification
Required
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
Proficiency in Quality by Design (QbD), Design of Experiments (DoE), statistical process control (SPC), and complex data analysis
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
Preferred
Development or manufacturing sciences experience in sterile filtration, aseptic fill/finish, and/or formulation development is strongly preferred
Familiarity with modeling and optimization tools (e.g., MATLAB, JMP) is a plus
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase