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Process Development Engineer II
Full Time
Watertown, Massachusetts, United States
Sponsors work visa for candidates.
Job description
Scismic is supporting the growth of a biotech company based out of Watertown, MA!
To support their ambitious pursuits, the Process Development Engineer II will be a Subject Matter Expert (SME) for their GMP bulk intermediate manufacturing process and will be instrumental in scaling up new ad-hoc projects.
The Process Development team is responsible for designing robust manufacturing operations for producing their clinical and commercial ImmTOR, polymer-based nano-particle product. The PD Engineer II role will provide tremendous learning potential in the area of cutting-edge manufacturing technologies for producing polymeric nanoparticles. You will have the opportunity to work in a cross functional team environment and contribute to the development, scale-up, and optimization of their nanoparticle manufacturing.
Principal Duties/Responsibilities:
- Use scientific principles and professional practices to solve a range of complex problems related to their cutting-edge nanoparticle manufacturing technology.
- Serve as Subject Matter Expert (SME) for GMP bulk intermediate manufacturing processes
- Draft experimental plans and execute experiments in their process development laboratory. Analyze and interpret results, and document in technical reports. Utilize this knowledge to expand process understanding in the manufacturing operations.
- Collaborate with Analytical Development, Formulation, and Quality to advance their various development programs.
- Support BLA filings with demonstrated excellence in writing reports
- Leverage process validation and process characterization experience to scale-up new projects
- Manage the CMO relationship by overseeing manufacturing activities and process improvements.
Desired Experience and Capabilities:
- Bachelors or master’s degree in chemical engineering, Bioengineering or related discipline with at least 5 years of industry experience
- Demonstrated experience with statistical analysis
- Creative problem solver
- Ability to work independently and safely in a pilot lab.
- Experience in GMP manufacturing and process development
- Excellent attention to details
- Ability to work with demanding deadlines and in a fast-paced work environment
- Excellent written and verbal communication and documentation skills
- Excellent teamwork and collaborative skills
Work Environment:
The position requires hands-on work setting up and operating equipment in an R&D laboratory. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to policies, rules and regulations is required.
While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.