Analytical Science Manager

Position Summary:

The Analytical Science Manager-Technical Operations provides technical expertise to support analytical method activities for drug substance and drug products. Ensures analytical methods are robust, compliant with global regulatory standards, and optimized for seamless execution in the lab.

• - 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 use Veeva eQMS to manage documents, deviations, change controls, and quality events.

• - In-depth knowledge of analytical instrumentation (HPLC, GC, LC-MS) and physical characterization techniques (XRPD, DSC).
• - Strong troubleshooting capabilities for complex analytical failures and instrument issues.
• - Thorough understanding of global regulatory mandates (ICH, cGMP) and industry best practices.
• - Strong collaboration and communication skills across cross-functional and global teams.
• - Good organizational and multi-tasking skills.

• - Master’s 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; ability to author regulatory documentation.
• - Hands-on experience with Veeva eQMS (highly preferred).

• - Parsippany, NJ or Lake Forest, IL; at least 2 days onsite at corporate headquarters on designated in-office days.

• - Up to 10% as needed for meetings, conferences, and company events.