Regulatory Product Operations Scientist

CICONIX; Frederick (MD); Sur place; USD 85 000 - 89 000; Plein temps

Avantages offerts par ce poste

Health insurance

PTO

401k

Résumé du poste

CICONIX LLC seeks a Product Technical Operations Scientist to support the Office of Regulated Activities (ORA) for the DHA R&D MRDC team in Fort Detrick, MD.

The role provides regulatory and technical support across manufacturing strategies, investigational product activities, QA/auditing, and document management to ensure GMP/GxP compliance and regulatory standards.

You will work with cross-functional teams, manage product storage/shipment, and aid in regulatory submissions during development.

Qualifications

• U.S. Citizenship and a successful background investigation are required.
• Ability to obtain and maintain a government security clearance.
• Willingness to comply with the government vaccination requirements.

Responsabilités

• Provide regulatory and technical support across manufacturing strategies and investigational product activities.
• Assist with development of product specifications and quality systems.
• Review master batch records, stability data, and COAs for compliance.
• Support regulatory submissions and QA/auditing activities per SOPs.

Connaissances

Regulatory support

Cross-functional coordination

GXP compliance

Documentation

Outils

LIMS

Description du poste

CICONIX LLC seeks a Product Technical Operations Scientist to support the Office of Regulated Activities (ORA) for the DHA R&D MRDC team in Fort Detrick, MD.

The role provides regulatory and technical support across manufacturing strategies, investigational product activities, QA/auditing, and document management to ensure GMP/GxP compliance and regulatory standards.

You will work with cross-functional teams, manage product storage/shipment, and aid in regulatory submissions during development.