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 characterization techniques (XRPD, DSC).
- Strong troubleshooting capabilities to resolve complex analytical failures and instrument issues.
- Thorough understanding of global regulatory mandates, including ICH guidelines, cGMP regulations, and industry best practices.
- Strong collaboration and communication skills across cross-functional and global teams.
- Good organizational and multi-tasking skills to successfully manage completing projects.
- Masters in Chemistry, Pharmaceutical Sciences, or related field with 5-10 years of pharmaceutical industry experience.
- Strong expertise in analytical method validation, and global method transfers.
- Excellent technical writing skills and ability to author regulatory documentation as required.
- Hands-on experience with Veeva eQMS is highly preferred
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
Ref: #568-Clinical
