Project Specialist I, Manufacturing

Scorpion Therapeutics; Waltham (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Scorpion Therapeutics is seeking a Project Specialist I in Manufacturing to support technical documentation, quality records, training, process improvements, and GMP compliance in autologous cell/gene therapy manufacturing.

You will manage deviations, CAPAs, change controls, and SOPs, oversee short-term scheduling and resource planning, coordinate technician training, and drive continuous improvement while enabling cross-functional collaboration with manufacturing, supply chain, and project

Qualifications

• Bachelor's degree in GMP/manufacturing with 3+ years experience.
• Experience in autologous gene/cell therapy manufacturing preferred.
• Proficiency in Excel, SAP, and Veeva; GMP quality systems knowledge.

Responsibilities

• manage deviations, CAPAs, change controls, and SOPs
• oversee short-term manufacturing scheduling, technician resource planning, and workforce alignment
• coordinate technician training, onboarding, and qualification tracking
• drive operational efficiency through continuous improvement initiatives
• facilitate cross-functional communication between manufacturing, supply chain, and project teams

Skills

Manufacturing scheduling

Resource planning

Cross-functional collaboration

Education

Bachelor's degree in GMP/manufacturing

Master's degree in related field

Tools

Excel

SAP

Veeva

Job description

Role

Project Specialist I in Manufacturing supporting technical documentation, quality records, training, process improvements, and compliance within GMP biopharma manufacturing, particularly in cell/gene therapy.

Responsibilities

• manage deviations, CAPAs, change controls, and SOPs


• oversee short-term manufacturing scheduling, technician resource planning, and workforce alignment


• coordinate technician training, onboarding, and qualification tracking


• drive operational efficiency through continuous improvement initiatives


• facilitate cross-functional communication between manufacturing, supply chain, and project teams

Requirements

• Bachelor's degree with 3+ years (or Master's with 1+ year) experience in GMP or manufacturing environment


• experience in autologous gene/cell therapy manufacturing preferred


• strong skills in manufacturing scheduling, resource planning, and proficient in Excel, SAP, Veeva


• knowledge of GMP quality systems

HighValue

experience in cell/gene therapy, autologous manufacturing, GMP compliance, and technical operations; focus on workforce and process optimization in fast-paced biopharma setting.

WorkSetup

on-site with physical requirements for routine GMP manufacturing activities.