Engineer II - MTS

Job Title:

MTS Engineer II

Location:

Cambridge, MA

Duration: 12+ Months

The Engineer II (MTS) will be a part of the internal Manufacturing Technical Services team; your support of critical activities within our team will help us bring our RNAi technology to patients.

We are looking for an energetic, collaborative, and curious individual to support late stage and commercial drug product manufacturing. Our new team member will be contributing to the DP technology transfer team to ensure robust manufacturing of our commercial drug products.

• Support Technology Transfer
  
  Activities:
  
  Assist in process scale-up, optimization, and technology transfer efforts for new drug product manufacturing at contract manufacturing organizations (CMOs). Participate in due diligence and technical assessments to ensure readiness for transfer.
• Manufacturing Support:
  Help assess deviations, contribute to change control documentation, and support CAPA development and risk assessments related to drug product manufacturing under guidance from senior staff.
• Data Analysis and Trending:
  Participate in routine process data collection and trending activities. Assist in preparing summaries and visualizations for internal reviews and management presentations.
• Continuous Improvement:
  Identify opportunities for process improvements and contribute to implementation plans. Collaborate with cross-functional teams to evaluate regulatory and operational impacts of proposed changes.
• Validation and Launch Support:
  Support the development of process validation protocols and sampling plans. Assist in execution and documentation of validation activities to meet GMP requirements.
• Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment, including process, equipment, and facility validation experience.
• Assist in the execution of development experiments in the lab as needed.

• Ensure commercial drug product manufacturing readiness prior to each lot.
• Support timely closure of deviations, investigations and CAPAs.
• Contribute to authoring process control documentation.
• Communicate updates to key cross-functional teams.
• Contributions to Manufacturing department / Alnylam goals and objectives.

• B.S. in applicable science field.
• 2+ years of experience in a laboratory setting.
• Competence with MS Word, Excel, and PowerPoint.
• Data Trending experience (Excel, JMP) is desirable.