Product Technical Operations Scientist

CICONIX, LLC•Fort Detrick, MD

2d•$89,000 - $91,000•Onsite

About The Position

CICONIX is seeking a Product Technical Operations Scientist to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD. This role provides regulatory and technical support for the development of manufacturing strategies and execution of investigational product activities throughout all phases of product development to ensure compliance with applicable regulations, guidance documents, policies, and standards. This includes Chemistry, Manufacturing and Controls/Good Manufacturing Practices/product accountability. The scientist will also provide investigational product and chemistry, manufacturing, and control support to integrated product teams, attend meetings, interact with manufacturing and quality units, develop strategies for and execute investigational product activities (storage, shipment, destruction), and provide input for final formulation. Additionally, the role involves assisting in developing product specifications, writing/reviewing/revising investigational product storage and handling instructions, obtaining and reviewing investigational product shipment records for accountability and cold chain management, facilitating import/export, managing shipping and destruction requests, updating product accountability systems (like LIMS), reviewing temperature logs, and maintaining accountability records in the Trial Master File (TMF). The scientist will also review master batch/executed production records, stability protocols/reports, product labels, and associated documents. Further responsibilities include developing, reviewing, and/or revising bioanalytical/analytical method and/or equipment qualification and validation protocols and reports, performing current Good Manufacturing Practices and current Good Laboratory Practices facility audits and site visits, and writing, reviewing, and revising regulatory submission documents in electronic Common Technical Document format. Finally, the role involves reviewing product data discrepancies (failures, deviations, Out of Specifications, Out of Trends, test anomaly reports, CAPAs, etc.) and managing them to resolution.

Requirements

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.

Responsibilities

Provide regulatory and technical support to the development of manufacturing strategies and execution of investigational product activities throughout all phases of the product development to ensure compliance with the applicable regulations, guidance documents, policies, and standards.
Provide investigational product and chemistry, manufacturing, and control support to integrated product teams or working groups.
Write, review, and/or revise investigational product specific storage and handling instructions.
Obtain and review investigational product shipment records to track product batch, review shipping conditions, and ensure product accountability and cold chain management.
Facilitate import and export of investigational product and ensure compliance with all the applicable regulations and requirements.
Manage Investigational Product shipping and destruction requests and respond to investigational product requests/order forms by keeping the product accountability system up to date including but not limited to a laboratory information management system (LIMS).
Review investigational product temperature logs from product shipments, document this review, and investigate any temperature excursions until resolution is achieved with a final report generated.
Add and maintain appropriate accountability records in the Trial Master File (TMF).
Review master batch/executed production records, stability protocols/reports, product labels, and associated documents (i.e. certificates of analysis) are adequate for the level of development and in compliance with applicable regulations.
Develop, review, and/or revise bioanalytical/analytical method and/or equipment qualification and validation (installation qualification, operational qualification and performance qualification protocols and reports and ensure they are adequate for the phase of development and in compliance with the appropriate regulations and requirements).
Perform current Good Manufacturing Practices and current Good Laboratory Practices facility audits and site visits IAW SOPs.
Write, review, and revise regulatory submission documents relevant to the investigational product and nonclinical efforts, in electronic Common Technical Document format located in Module 2, Module 3, and Module 4.
Review product data discrepancies (failures, deviations, Out of Specifications, Out of Trends, test anomaly reports, CAPAs, etc.) found in the testing records to include managing discrepancies to resolution through the proper Good Manufacturing Practices course of action; communicate discrepancies through periodic reports to ORA leadership.