Skills

Communication Data Analysis Data collection Organization

Job Specifications

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.

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.

Accountabilities:

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/client goals and objectives.

Reports to: Principal Engineer, Manufacturing Technical Services

Knowledge/Experience/Skill:

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

Travel between domestic client sites may be required (Cambridge and Norton).

Competencies

Ability to work independently
Excellent team skills, organization, collaborative spirit, and strong communication skills (written and verbal)
Ability to maneuver through changing priorities
Experience or exposure to working in GMP environments is desired

Physical/Environmental Factors

Must be able to adhere to all laboratory safety requirements
Ability to travel between domestic client sites is helpful (Kendall, Alewife and Norton)
May be required to lift objects up to 50lbs

About the Company

Integrated Resources Inc. (IRI) is a professional staffing firm specializing in contract, consulting & full time positions in the area of Information Technology, Life Science and Allied Healthcare. Since its inception in 1996, IRI has continued to grow in size, opportunities, service and quality. Our expert team of highly trained counselors work hand in hand with every candidate and client forming a partnership of understanding and commitment. Know more