The Role
Supports investigational product development and manufacturing compliance across the product lifecycle. Responsibilities include CMC and GMP support, product accountability, storage and shipment oversight, formulation and specification development, document and regulatory submission review, analytical method validation, facility audits, deviation and CAPA management, temperature excursion investigations, and Trial Master File maintenance for military health research programs.
Summary Generated by Built In
Product Technical Operations Scientist
About CICONIX: CICONIX LLC is a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. We value exceptional people, unwavering integrity, inclusive collaboration, and enduring impact.
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Location(s): Fort Detrick, MD
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Position Details:
- Full-time position
- Regular weekly hours (0900-1600)
- No calls, nights, weekends, or holidays!
- Full benefit program, including: health, PTO, & 401k + contribution
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Requirements:
- TBD
Summary:
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.
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About the Role:
- 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. Investigational product and chemistry, manufacturing, and control support includes but is not limited to the following: Chemistry, Manufacturing and Controls/Good Manufacturing Practices/product accountability.
- Provide investigational product and chemistry, manufacturing, and control support to integrated product teams or working groups. This includes working with team members, attending meetings with the team and industry partners, interacting with the manufacturing and quality units, developing strategies for and executing investigational product activities, including investigational product storage, shipment, and destruction, throughout all phases of the product development; Providing input for the final formulation of the investigational product, which may require specific subject matter expertise (e.g. Small molecule formulations); Assist in developing product specifications (list of tests, references to analytical procedures, and appropriate acceptance criteria) for drug, biologic, medical devices, and combination products.
- Write, review, and/or revise investigational product specific storage and handling instructions, which may be written in the investigational brochure, clinical protocol, pharmacy manual or other clinical documents.
- 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. Site visits can be for pre-award assessment visits, site qualification visits, due-diligence visits, person in-plant visits, and for-cause inspections. Provide audit reports and documentation of follow-up for review and comment prior to finalization.
- Regulatory operations: 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.
- QA/auditing : 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.
Qualifications:
- Education:
- TBD
- Licensure & Certifications (Current & Unrestricted):
- TBD
- Experience:
- TBD
- Security & Background Check:
- U.S. Citizenship and a successful background investigation are required.
- Ability to obtain and maintain a government security clearance.
- Additional Requirements:
- Willingness to comply with the government vaccination requirements.
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Compensation: $85k - $89k
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CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.
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Skills Required
- U.S. citizenship
- Successful background investigation
- Ability to obtain and maintain a government security clearance
- Compliance with government vaccination requirements
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The Company
What We Do
CICONIX is a veteran-owned small business that provides business advisory and technical assistance, with an emphasis on military and Veterans healthcare programs. Its services span medical research and development, operational medicine support, health information management and technology, organizational development and training, clinical support, program development and management advisory services, Lean training, and healthcare talent acquisition for government and healthcare clients.
