Senior Manager, Analytical Manufacturing Science and Technology

Scorpion Therapeutics; Hopewell (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Manager of Analytical MST to lead analytical method transfers and oversee the MST Analytical Laboratory supporting biologics drug substance and product manufacturing.

You will provide strategic and technical oversight for analytical capabilities, manage method transfers to QC labs, and support readiness for new product launches. This role requires leadership of cross-functional teams, regulatory documentation, and staff development.

Qualifications

• A bachelor’s degree in analytical chemistry, biochemistry, or a related field.
• 7+ years biopharma experience.
• 5+ years of leadership in analytical teams or projects.
• Experience with analytical method transfer, validation, and regulatory documentation.

Responsibilities

• Provide strategic and technical oversight for analytical capabilities.
• Manage method transfers of physicochemical, potency, and structural characterization to QC labs.
• Support analytical readiness for new product launches and lifecycle projects.
• Perform or supervise testing using HPLC/UHPLC and CE technologies.
• Author and review GMP documentation.
• Support regulatory submissions.
• Establish metrics and governance for transfer progress.
• Lead cross-functional collaboration with manufacturing, quality, CMC, regulatory, and external partners.
• Manage and develop laboratory personnel.
• Build a capable analytical team supporting tech transfer and process development.

Skills

Leadership

Cross-functional collaboration

Project management

Regulatory awareness

Education

Bachelor’s in analytical chemistry/biochemistry/related

Tools

HPLC/UHPLC

CE (Capillary Electrophoresis)

Job description

Role

Senior Manager of Analytical Manufacturing Science and Technology (MST) leading analytical method transfers and overseeing the MST Analytical Laboratory supporting biologic drug substance and drug product manufacturing.

Responsibilities

• provide strategic and technical oversight for analytical capabilities
• manage method transfers of physicochemical, potency, and structural characterization to QC labs
• support analytical readiness for new product launches and lifecycle projects
• perform or supervise testing using HPLC/UHPLC and CE technologies
• author and review GMP documentation
• support regulatory submissions
• establish metrics and governance for transfer progress
• lead cross-functional collaboration with manufacturing, quality, CMC, regulatory, and external partners.
• Manage and develop laboratory personnel
• build a capable analytical team supporting tech transfer and process development.

Requirements

• Bachelor's in analytical chemistry, biochemistry, or related field with 7+ years biopharma experience
• expertise in biologics analytical methods and protein QC attributes
• 5+ years of leadership in analytical teams or projects
• experience with analytical method transfer, validation, and regulatory documentation

Preferred

Master's degree, experience with regulatory submissions, lab start-up, or capability expansion.

High-Value

biologics (monoclonal and bispecific antibodies), analytical method transfer, GMP, biologics QC, lifecycle support, global cross-functional collaboration.

Work setup

up to 10% travel.