R&D Analytical Develpment Scientist II
Core
Develop, optimize, validate, and transfer analytical methods for small molecules and biologics to support pharmaceutical product development, registration, and manufacturing.
Role type
Senior analytical development scientist (pharmaceuticals)
Builds
Validated analytical methods and protocols for drug development and regulatory submission
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Analytical method development and optimization, Validation and transfer of analytical methods, U/HPLC, ELISA, Capillary Electrophoresis (CE), GMP compliance, Technical supervision of analysts, Data trend analysis, Regulatory monograph verification (USP/EP), Laboratory procedure development
Preferred skills
Prior experience in pharmaceutical analytical development within regulated environments (via careerplan.io/jobs/JR119798-rd-analytical-develpment-scientist-ii-at-pciservices)
Technologies
U/HPLC, ELISA, CE-SDS, CIEF, SEC, RP, HILIC, IEX, Western blot
Responsibilities
Develop and optimize new or existing analytical methods for small molecules and biologics; Create transfer and validation protocols and reports; Supervise analytical development analysts and provide technical support; Review analyst-generated documentation and evaluate data trends; Verify new USP/EP monographs; Collaborate with formulation and production departments on sample analysis; Participate in internal and external audits
Seniority
Senior, hands-on IC