Product Technical Operations Scientist (Regulatory & GMP)

CICONIX, LLC; Frederick (MD); On-site; USD 85,000 - 89,000; Full time

Benefits offered by this job

Health insurance

Paid time off

401(k)

Job summary

CICONIX LLC is seeking a Product Technical Operations Scientist to support the DHA R&D MRDC team at Fort Detrick, MD. The role involves regulatory and technical support for manufacturing strategies, investigational product activities, and CMC responsibilities across all development phases.

Responsibilities include handling investigational product storage/shipment, reviewing development records, and contributing to product specifications and QA/audit activities.

Responsibilities

• Provide regulatory and technical support for development of manufacturing strategies and CMC activities across all development phases.
• Oversee investigational product storage, shipment, and destruction, ensuring cold chain integrity and compliance with regulations.
• Review master batch records, stability protocols, COAs, and related documents for development readiness.
• Develop and review bioanalytical/analytical method qualification and validation, ensuring alignment with regulations.

Job description

CICONIX LLC is seeking a Product Technical Operations Scientist to support the DHA R&D MRDC team at Fort Detrick, MD. The role involves regulatory and technical support for manufacturing strategies, investigational product activities, and CMC responsibilities across all development phases.

Responsibilities include handling investigational product storage/shipment, reviewing development records, and contributing to product specifications and QA/audit activities.