Senior Technical Product Manager

CICONIX, LLC•Fort Detrick, MD

1d•Onsite

About The Position

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. CICONIX is seeking a Senior Technical Product Manager 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 functions as the Product Technical Operations lead at the individual team level by providing 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 is a key aspect of the role.

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 investigational product and chemistry, manufacturing, and control support to integrated product teams or working groups.
Work with team members, attend meetings with the team and industry partners, interact with the manufacturing and quality units.
Develop strategies for and execute investigational product activities, including investigational product storage, shipment, and destruction, throughout all phases of the product development.
Provide 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 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.
Provide audit reports and documentation of follow-up for review and comment prior to finalization.
Write, review, and revise regulatory submission documents relevant to the investigational product and nonclinical efforts, in electronic Common Technical Document format.
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.
Provide regulatory support for nonclinical development to ensure compliance with the applicable regulations, guidance documents, policies, and standards.
Provide nonclinical subject matter expertise to integrated product teams or working groups and update ORA leadership as needed.
Develop and/or review protocols and reports for Good Laboratory Practices and non-Good Laboratory Practices efforts, including but not limited to toxicological, pharmacokinetic, and genotoxicity studies, and ensure or evaluate compliance with the designated quality system and applicable regulatory requirements.
Create and maintain Target Product Profiles and provide to the Government.
Review non-clinical protocols and reports for compliance with Good Laboratory Practices.
Conduct clinical, non-clinical, and manufacturing site visits for compliance assessment and provide site visit reports.
Identify and mitigate product and manufacturing risk through a project Risk Register.
Lead a regulatory intelligence working group and stay updated on regulatory trends and changes, proactively adapting strategies to maintain compliance.
Work closely and collaborate with Cross-Functional teams to align regulatory strategies with program and organizational objectives.
Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities.
Lead, mentor and train a team of junior PTO scientists, fostering their development, managing workloads and ensuring alignment with organizational goals.
Lead and/or actively participate in working groups for ORA process improvement, continued learning, regulatory intelligence, and quality review.
Write, review, and/or revise SOPs.