Engineer II - MTS

Job Summary
The Engineer II (MTS) supports late-stage and commercial drug product manufacturing within the Manufacturing Technical Services team. This role contributes to technology transfer, process validation, and continuous improvement to ensure robust manufacturing of the companies RNAi therapeutics.

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.

Summary of Key Responsibilities:
•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

Qualifications:
B.S. in a relevant science field; 2+ years of lab or GMP experience.
Proficiency with MS Word, Excel, and PowerPoint; JMP experience a plus.
Strong organizational, communication, and teamwork skills.
Ability to work independently and adapt to changing priorities.
Travel between sites (Cambridge and Norton) may be required.
Must meet lab safety standards; ability to lift up to 50 lbs.

Pay Range: 32-38/hr (based on experience)