job summary: **URGENT NEED
for a Senior Scientist to support the CMC team. This person will design, manage, and implement analytical development activities to support all stages of drug development.**
location: Allentown, Pennsylvania
job type: Permanent
salary: $80,000 - 90,000 per year
work hours: 9 to 5
- Use advanced analytical technologies to design, manage, and implement analytical development activities to support all stages of drug development.
- Represent department and actively participate in multiple CMC sub-teams: contribute to team strategies; provide high quality data to guide understanding and decisions; collaborate with other functional areas to solve technical problems and meet project development milestones.
- Must have knowledge and skills for Operation, Calibration, Qualification, Preventive maintenance and routine trouble shooting of analytical instruments like UPLC, HPLC, GC, UV spectrophotometer, Dissolution apparatus, KF Autotitrator, FT-IR Spectrophotometer, Polarimeter, Refractometer, Mass spectroscopy, Laser Diffraction Particle Size analyzer, etc.
- Develop, validate, and transfer analytical methods for drug substance, drug product and excipients.
- Troubleshoot and solve analytical problems to assure timely completion of projects and technical reports to meet CMC project timelines.
- Proactively identify potential analytical or project issues and mitigate or address appropriately.
- Bachelor's Degree (BA/BS) in chemistry or other relevant pharmaceutical sciences is required with minimum of 7 years of experience in analytical method development and validation or Master Degree (MS/MA) in chemistry or other relevant pharmaceutical sciences is required with minimum of 4 years of experience in analytical method development and validation.
- Extensive knowledge of Good Manufacturing Practices, FDA/ICH Guidelines, and Compendial references (USP/Ph. Eur., etc.).
- Experience using laboratory instrument data acquisition software (Empower, Chemstation, etc.).
skills: Analytical Chemistry
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.