General Dynamics Information Technology – Federal Civilian Division is looking for a Product Technical Operations Scientist to join our team to support the Department of Army. This position is based in the Ft. Detrick and Frederick, Maryland. Duties include:
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 the sponsor’s product accountability system; Maintain the product accountability log
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 document
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; communicate 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
Bachelor’s Degree or the equivalent combination of education, professional training, or work experience.
2+ years of related experience.
Must be highly organized, detail oriented, and perform independently.
Have excellent Microsoft Excel Spreadsheet skills.
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a TI (Public Trust).
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
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.