Product Technical Operations Scientist (Manufacturing experience)

General Dynamics' (GDIT) Military Health team is looking for a Product Technical Operations Scientist to join our team to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.This position is based at Ft. Detrick in Frederick, Maryland.Learn More HERE HOW YOU WILL MAKE AN IMPACT:

• Provide investigational product and chemistry, manufacturing, and control support to integrated product teams or working groups, which includes working with the team members, advising the team of investigational product and chemistry, manufacturing, and control activities and issues, and attending meetings with the team and any industry partners.
• Develop strategies for and execute investigational product activities, including investigational product storage, shipment, and destruction, throughout all phases of the product development; Review and document investigational product accountability, which includes maintaining adequate product receipt, shipment, inventory, and distribution records including temperature logs.
• 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, devices, and combination products.
• Review product labels for compliance with applicable regulations and requirements; update leadership and the sponsor's representative through routine reports.
• Write, review, and revise regulatory submission documents relevant to the investigational product, such as sections of the protocol relevant to investigational product, investigational brochures, etc.
• Release and document investigational product to clinical and nonclinical sites; Interact with the manufacturing and quality units conducting lot release functions and provide current Good Manufacturing Practices documentation for the investigational product; Review and document that the lot release documentation is adequate for the phase of development.
• Review the investigational product certificates of analysis and test data for product compliance with the pre-established specifications and to ensure test data are adequate for IND application submission and the phase of development; update and complete data entry to the sponsor's product accountability database and Laboratory Information Management (LIMS) Systems.
• Maintain the product accountability log for both commercial and investigational products.
• Write, review, and/or revise investigational product specific storage and handling instructions, which may be written in the investigational brochure, protocol, pharmacy manual or other documents
• Review product data to ensure they meet all established specifications and document and investigate any discrepancies (failures, Out of Specifications, Out of Trends, etc.) found in the testing records and including managing deviations, test anomaly reports and corrective and preventive action plans, communication discrepancies through periodic reports to leadership and sponsor's representative as necessary.
• Add and maintain appropriate records in the Trial Master File (TMF).
• Review master batch production records and document that the records are acceptable and in compliance with current Good Manufacturing Practices; Review batch production records, which are the executed master batch production records, and document that the records are adequate and in compliance with current Good Manufacturing Practices.
• Review and revise stability protocols and reports and document that the protocols and reports are adequate for the product and the level of development and are in compliance with applicable regulations and requirements.
• Review non-clinical protocols and reports for compliance with Good Laboratory Practices (GLP).
• Conduct clinical and non-clinical, and manufacturing site visits for compliance assessment and provide site visit reports.

WHAT YOU'LL NEED TO SUCCEED:

• Bachelor's Degree or the equivalent combination of education, professional training, or work experience.
• 5+ years of related product manufacturing experience with medical products and highly organized, detail oriented, and perform independently as a Subject Matter Expert within a project team.
• Knowledgeable of CFRs and GMPs.
• Excellent written and oral communication skills.
• Must be U.S. citizen and be able to obtain a TI (Public Trust).

WHAT GDIT CAN OFFER YOU:

• Challenging work that makes a real impact on the world around you
• Internal mobility team dedicated to helping you own your career
• 401K with company match
• Diverse, highly collaborative teams
• Professional development, education assistance, certification and training opportunities

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Work Requirements

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Years of Experience
5 + years of related experience

* may vary based on technical training, certification(s), or degree

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Certification

Travel Required
None

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Citizenship
U.S. Citizenship Required

About Our Work

We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.