PHARMACEUTICAL CHEMIST

Responsibilities

• Perform API/finished-product characterization/specification finalization
• Conduct preformulation/compatibility studies
• Develop generic product /scale up solid oral prototypes using QbD/DoE
• Optimize CPPs
• Execute tech transfer, GMP/validation batches, Commercial support, BE/ANDA support, IVIVC
• Stability programs
• Comprehensive CMC/GMP documentation/SOPs

Qualifications

• Masters (or foreign equivalent degree) in Pharmaceutical Science
• Knowledge of product/process development of dosage forms per ICH/USFDA/SUPAC guidelines
• Experience with scale-up/ANDA batches
• Conduct preformulation studies
• Preparation of site transfer documents
• Preparation of PDR, SOP/Qualification protocols

Pay

$82K