Job Description:

Description

DETAILED DESCRIPTION

ICON Government and Public Health Solutions specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.

ESSENTIAL FUNCTIONS:

Reasonable Accommodation Statement:

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.

- Shall provide support for a variety of investigational product development plans and efforts and provide knowledgeable regulatory compliance information relating to GMP, GLP, and GCP.

- Specifically, the Contractor shall provide commercial sector manufacturing perspective to Principal Investigators, advanced development Product Managers, and others as they seek compliance with FDA rules and regulations.

- Consult on the developmental-appropriate scientific and documentation requirements for compliance of facilities/laboratories and associated assays and processes from the sponsor's perspective.

- Interact frequently with Regulatory Affairs (RA) Scientists, Product Managers, Clinical Affairs, Branch Chiefs, Laboratory Directors, Laboratory Technicians, Quality Assurance representatives, and the Director of Regulatory Affairs.

- Provide support by developing and assisting with laboratory and manufacturing compliance activities and related documentation to include those related to: product-related assays, product testing, accountability, manufacturing, laboratory, data systems and equipment.

- Facilitate efficient development of the product while ensuring compliance.

- Support product development strategy as it pertains to the extent of compliance needed as a function of the appropriate stage of product development.

- Provide manufacturing and testing related regulatory compliance information with appropriate individuals, teams, and forums to reduce and/or prevent critical errors that may inhibit the development of products.

- Shall support (1) research protocol development and review, (2) assay development and validation, (3) regulatory compliance for clinical and non-clinical studies, and (3) oversight of the performance of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs), including site visits.

- Function as a representative on USAMRMC Product Teams and provide technical product manufacturing and testing, nonclinical testing, and investigational product accountability support for efforts spanning the development life cycle, from early \\"tech base\\" to advanced development.

- Interpret FDA regulations and guidance and provide requirements and recommendations to USAMRMC Product Teams as related to product manufacturing, product release testing, nonclinical testing, analytical testing, and validation efforts, in order to achieve FDA product approval.

- Conduct pre-qualification, for-cause, and person-in-plant manufacturing site visits; clinical site initiation visits, generate trip reports, document deficiencies, and follow up with corrective actions.

- Communicate effectively and shall interface with RA Scientists, Quality Assurance representatives, Clinical Research Associates, and Product Managers as well as interface with other Government agencies and Contractors involved in medical product development efforts.

Candidates for positions under ICON Government and Public Health Solutions contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.

WORKING CONDITIONS/PHYSICAL DEMANDS:

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT:

Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.Qualifications

Experience
5 years: Manufacturing experience (required)
Experience with cGMP, GLP and familiarity with GCP. (required)
Need experience specific to manufacturing drugs, vaccines and small molecules. (required)
Strong analytical experience in method development and validation. (required)
eCTD experience with IND submissions including authoring and review for successful FDA submissions with Modules 2, 3 and 4. (required)
Experience with FDA meetings acting as the CMC representative. (required)

Licenses & Certifications
RAC (preferred)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c).

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