Position: Analytical Science ManagerPosition Summary: The Analytical Science Manager-Technical Operations provides critical technical expertise to support analytical method related activities for both drug substance and drug products. Reporting directly to the Director, the Analytical Science Manager collaborates closely with cross-functional and external partners to support manufacturing readiness. This role ensures all analytical methods are robust, compliant with global regulatory standards, and optimized for seamless execution in lab.
Primary 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.
Skills & 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.
Qualifications:- 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
Work Location:- This role is based in Parsippany, New Jersey or Lake Forest, IL and requires at least 2 days onsite presence at the corporate headquarters on designated in-office days.
Travel Requirements:- Ability to travel up to 10 % as needed for meetings, conferences, and company events.
