Job Description
Job Title: Analytical Science Manager
Location: Parsippany, NJ
Type: Direct Hire
Compensation: $100,000.00 - $135,000.00
Work Model: Hybrid – onsite and remote
Responsibilities
+ Lead analytical method transfers and validation activities for drug substance and drug products.
+ Author and review GMP documents such as SOPs, protocols, summary reports, and QMS records.
+ Partner with Quality Assurance, Regulatory Affairs, and external test sites to support technology transfers, and analytical method validations.
+ Support technical investigations for out-of-specification (OOS) results and collaborate with QA to implement corrective actions.
+ Serve as department Quality liaison and utilize Veeva eQMS to manage documents, deviations, change controls and quality events.
Requirements
+ In-depth knowledge of analytical instrumentation (HPLC, GC, LC-MS), and physical characteriza...
Location: Parsippany, NJ
Type: Direct Hire
Compensation: $100,000.00 - $135,000.00
Work Model: Hybrid – onsite and remote
Responsibilities
+ Lead analytical method transfers and validation activities for drug substance and drug products.
+ Author and review GMP documents such as SOPs, protocols, summary reports, and QMS records.
+ Partner with Quality Assurance, Regulatory Affairs, and external test sites to support technology transfers, and analytical method validations.
+ Support technical investigations for out-of-specification (OOS) results and collaborate with QA to implement corrective actions.
+ Serve as department Quality liaison and utilize Veeva eQMS to manage documents, deviations, change controls and quality events.
Requirements
+ In-depth knowledge of analytical instrumentation (HPLC, GC, LC-MS), and physical characteriza...