Sr. Engineer/Engineer III (MS&T)
This position is part of the Manufacturing Science and Technology (MS&T) department to support our efforts to specify and implement new equipment while expanding manufacturing capacity. The individual will work cross-functionally with internal stakeholders (Manufacturing, Supply Chain, Regulatory, and Quality Teams) as well as external suppliers and CMOs to establish processes. The individual will help ensure that all aspects of technology transfer and technical support are successfully executed. The candidate should have a breadth of experience working with biopharmaceutical processing equipment and a good attention to detail.
Here’s What You’ll Do:
- Support expansion of production capabilities by working with CMOs to correctly outfit their manufacturing process.
- Perform technology transfer activities into CMOs.
- Provide startup technical support of cGMP manufacturing at CMOs.
- Lead cross functional troubleshooting and operational improvements for manufacturing process and equipment.
- Author and execute protocols supporting process improvements and equipment scale up in cGMP Manufacturing.
- Maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing platforms, shared manufacturing issues, and common solutions.
Here’s What You’ll Bring to the Table:
- Biochemical engineer, Chemical engineer, or Biochemistry background. BS with 5 to 10 years’ experience or MS with 3 to 5 years’ experience in a pharmaceutical or biotechnology company.
- Process development or operational experience in one or more of the following bioprocessing unit operations: enzymatic reaction, chromatography, tangential flow filtration, buffer formulation, drug product formulation, and aseptic filling.
- Prior experience in identifying, procuring, and implementing new process equipment.
- Prior experience providing technical support in a cGMP manufacturing environment.
- Experience in biologics process development or cGMP manufacturing of biologic products.
- Experience in working with SS equipment and tanks
- Knowledge of cGMP equipment commissioning and validation.