Description

Senior Technical Product Manager

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.

Location(s): Fort Detrick, MD

Position Details:

Full-time position
Regular weekly hours (0900-1600)
No calls, nights, weekends, or holidays!
Full benefit program, including: health, PTO, & 401k + contribution

Requirements:

Summary:

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.

About the Role:

Function 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 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 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.
- 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.
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. Studies include, but are not limited to bench performance testing, biocompatibility, In vivo or in vitro, toxicological, pharmacokinetics, and genotoxicity studies. Nonclinical support includes but is not limited to the following:
- Good Laboratory Practices and Non-Good Laboratory Practices
  - 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. The target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate.
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.

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.

Compensation: TBD

*This position is contingent and will begin upon contract award.

CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.

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Senior Technical Product Manager

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