Manages analytical projects in support of the development of a manufacturable multi-source pharmaceutical product. Conducts testing, analytical method development and validation in support of regulatory submissions and product launches. Troubleshoots and improves analytical methods. Manages analytical project time-lines, and coordinates analytical activities to meet the business deadlines. Coaches and mentors peers.
PhD in a scientific discipline with a minimum of 5 years experience,or
MS in a scientific discipline with a minimum of 8 years experience, or
BS/BA in a scientific discipline with a minimum of 10 years of experience.
The work related experiences include development, validation, execution and transfer of analytical methods for APIs or drug products.
For API: experience in HPLC, GC and particle size is required. Experience in one of the following techniques is preferred: DSC/TGA, DVS, MS, XRD.
For Product: experience in HPLC and dissolution is required. Experience in two of the following techniques is required: GC, droplet size, particle size, DSC/TGA, DVS, MS, XRD, AA, NIR.