Career Category

Job Description

Job Description:

The associate scientist will work within the Process Sciences group in the ASM Biologics Drug Substance Process Development department.

• Plan and lead laboratory-based experiments in conjunction with drug substance colleagues to support small-scale model qualification, investigations, and process improvements.
• Generate technical and scientific reports.
• Support Process Development laboratory operation, including managing PD lab equipment and preventive maintenance.
• Participate in teams and collaborate cross-functionally with representatives from other functions and sites to transfer and support drug substance manufacturing processes
• Applies expertise to support commercial lifecycle of a product, including troubleshooting of unit operations and new process technology transfer.
• When needed, support the commercial team to review process trends and integrate data/information into plans and recommendations
• Interfacing with Amgen network for collaboration, alignment, and conflict resolution.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Basic Qualification:

• Bachelor’s degree & 6 years of scientific experience OR Master’s degree & 4 years of Scientific experience

Competencies / Skills:

• Strong experience in running bench scale cell culture. Experience with biological purification is a plus
• Experience in supporting clinical and/or commercial pharmaceutical manufacturing
• Experience in design of experiment (DoE) and statistical analysis tools such as JMP software
• Experience with the use of biologics analytical instruments and interpreting the scientific data based upon these techniques.
• Demonstrated communication and scientific writing skills.
• A scientific track record which may include peer reviewed publications, scientific conference participation