Sr. Development Engineer (FY07-164)

Job Description:

 

The Senior Process Development Engineer will be responsible for development, scale-up, and support of new and existing processes, particularly those related to the Alkermes sustained release injectable products. Individual will be expected to lead the design and development testing of new process technologies at the laboratory, pilot, and production scales and work with vendors to specify and build process equipment. Planning and executing experimental plans for process development and preparation of user requirement documents and process turnover packages for manufacturing is expected as part of this role. Leadership of scale-up activities to take a process from development/pilot scale to commercial production is expected.

 

For existing processes, individual will be responsible for optimization of process parameters to achieve desired finish product properties. Examples of desirable process targets would include cycle time reduction and yield improvement. Experimental testing of optimization options at the lab, pilot, and production scales will be routine.

 

In all projects, individual will be expected to run development experiments in a hands-on fashion as well as provide leadership for other junior engineers and process technicians. Data analysis and interpretation, modeling, documentation, and presentation of results is expected. Individual will be expected to become a key problem solver and process expert who is a technical resource for and key liaison between development and manufacturing. Other responsibilities will include determining critical process parameters and ways to control them, troubleshooting technical problems in development and manufacturing, and coordinating activities with external resources such as consultants and contract manufacturers.

 

Job Requirements:

 

Bachelor's degree in chemical engineering or related field with 5-10 years experience in process development and scale-up activities. Master's degree or PhD in chemical engineering along with less experience is acceptable. Experience with industrial pharmaceutical process development and manufacturing, including cGMP and validation protocols is required. Working knowledge of clean-in-place techniques is needed. Experience with process control and PAT is also valued but not required.

 

A successful candidate will be a motivated self-starter who can manage complex development projects and solve challenging technical problems. The individual will also have the ability to conceptualize, design, develop, build, and optimize industrial processes relevant to the pharmaceutical industry and will demonstrate a strong history of success in leading experimentally-driven process development efforts. Excellent written and oral communication and strong problem solving skills are expected as is the ability to plan and execute efficient experimental designs and interpret and summarize results with appropriate statistical analyses. Familiarity with cGMP operations is a plus but is not required.

 

Individual will be self-motivated, comfortable as a team player and individual contributor, open-minded, and positive. Demonstrated leadership of both people and projects is required.

 



Why Alkermes? 

 

Alkermes is a world leader in the development of products based on sophisticated drug delivery technologies.  We partner with many of the world?s finest pharmaceutical companies and leverage our own proprietary technologies that make a difference in people?s quality of life.  Our business is demanding, yet we strive to make Alkermes a company where people can grow, excel and have a rewarding personal and professional experience.  We are a mature company with established products and product technologies, yet we are small enough that every employee makes a difference ? and contributions are clearly recognized.  In addition to a competitive salary, Alkermes offers a comprehensive benefits plan including Medical/Dental Insurance, 401(k) plan with immediate vesting, stock options, and a generous vacation and holiday schedule.

 

Headquartered in Cambridge, MA, our Wilmington, Ohio manufacturing facility is expanding operations and product lines. For more information please visit www.alkermes.com.