Job Summary
The Chemical Technical Operations Unit is seeking a highly motivated individual to fill an open position to support drug substance tech transfer and commercial manufacture within our External Manufacturing Network.
Responsibilities:
* Work with external partners to achieve business goals and establish a common culture that benefits our company, external partners, and patients.
* Lead and act as the primary interface on technical issues between Chemical Technical Operations and external partner API manufacturers.
* Responsible for technical transfer activities through review of GMP documentation, including Master Batch Records, change control, protocols, reports, qualifications, etc.
* Develop solutions to complex technical issues requiring ingenuity, creativity, and innovation.
Requirements:
* Bachelor's degree in Chemistry, Chemical/Biochemical Engineering, Pharmaceutical Science, or other related science or engineering field.
* Minimum 7 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations or Technical Operations.
* Experience in Quality Risk Assessments, deviation management, and change control.
Preferred Qualifications:
* Project management experience.
* Knowledge of worldwide regulatory requirements and experience supporting regulatory inspections.
* Experience in ADC manufacturing.
Key Skills:
* API Manufacturing Chemistry External Manufacturing.