What are the responsibilities and job description for the Engineer II - MTS position at BioPharma Consulting JAD Group?
The Engineer II (MTS) is a key member of the internal Manufacturing Technical Support (MTS) team, supporting critical activities within our manufacturing team to advance our RNAi technology. This is a lab-based position with a focus on general lab work, including conducting experiments and testing within our drug product and combination product (device) development labs. The Engineer II will execute experiments, perform in-process and final product testing, and support non-GMP manufacturing operations at our Cambridge development labs.
Key Responsibilities:
- Assist in the execution of development experiments.
- Provide laboratory organization support for general operations.
- Execute and document drug delivery device testing with guidance.
- Perform analytical in-process and final product testing for bulk drug product and drug product, including compendial methods, UPLC/HPLC, particle size analysis, and spectroscopy.
- Assist in coordinating routine and non-routine sample submissions, including receipt, aliquoting, inventory management, and shipping to external laboratories.
- Contribute to the creation and revision of technical documents (e.g., SOPs, protocols, reports).
- Support and contribute to method and equipment lifecycle activities, including implementation, qualification, validation, and maintenance.
- Assist management and team members with investigations, particularly in commercial manufacturing problem-solving.
- Support CAPA initiatives and continuous improvement efforts.
Accountabilities:
- Execution of routine laboratory experiments.
- Support for routine testing within communicated timelines.
- Continuous operation and maintenance of the MTS laboratory.
- Contributions to Manufacturing department and organizational goals.
Knowledge and Skills:
- Ability to work independently and manage multiple priorities.
- Strong teamwork, organizational, and communication skills.
- Capacity to adapt to changing priorities and fast-paced environments.
Physical/Environmental Factors:
- Must comply with all laboratory safety requirements.
- Ability to travel between Alnylam sites (Kendall, Alewife, and Norton) as needed.
- May be required to lift objects up to 50 lbs.
Education and Experience:
- Bachelor's degree in a relevant scientific field (e.g., biochemistry, chemistry, or other wet lab experience).
- Degree in engineering.
- Minimum 2 years of professional lab experience.
- Background in engineering, process development, or executing investigations in the lab (particularly related to commercial manufacturing problems).
Scope:
- Location: Primary worksite is Cambridge, MA. The ability to commute to Norton as needed is required.
- Work Schedule: Monday - Friday, 9:00 AM - 5:00 PM. No weekend work required.
