More jobs:
Senior Manager, Analytical Manufacturing Science and Technology
Job in
Hopewell, Mercer County, New Jersey, 08525, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
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.
- 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
Master's degree, experience with regulatory submissions, lab start-up, or capability expansion.
High-Valuebiologics (monoclonal and bispecific antibodies), analytical method transfer, GMP, biologics QC, lifecycle support, global cross-functional collaboration.
Work setupup to 10% travel.
Position Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×