Analytical Science Manager

Scorpion Therapeutics; Parsippany-Troy Hills (NJ); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics seeks an Analytical Science Manager-Technical Operations to provide technical expertise for analytical method development, transfers, and validation across drug substance and products.

You will ensure methods are robust, compliant with global regulatory standards, and optimized for seamless lab execution. Collaboration with QA, Regulatory Affairs, and external test sites is essential, with documentation and quality events managed via Veeva eQMS.

Qualifications

• Master’s in Chemistry, Pharmaceutical Sciences, or related field.
• 5–10 years of pharmaceutical industry experience.
• Strong expertise in analytical method validation and global method transfers.

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 QA, regulatory affairs, and external test sites to support technology transfers and validations.
• Support investigations for OOS results and implement CAPAs with QA.
• Serve as department QA liaison and manage documents, deviations, change controls, and quality events using Veeva eQMS.

Skills

HPLC

GC

LC-MS

XRPD

DSC

Regulatory knowledge

Cross-functional collaboration

Education

Master’s in Chemistry or Pharmaceutical Sciences

Tools

Veeva eQMS

Job description

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.

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 use 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 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.

Qualifications:

• - 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).

Work Location:

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

Travel Requirements:

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