Product Technical Operations Scientist

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 compliance, clinical (GCP), non-clinical (GLP), manufacturing (GMP), data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.

This is a PART TIME position (20 hrs a week), and is located in Frederick, Maryland. It is a hybrid role, and you would be required to be on-site 2 days/week.

Duties include:

• Provide investigational product and chemistry, manufacturing, and control (CMC) 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. Biologics, Small molecule formulations); Assist in developing product specifications (list of tests, references to analytical procedures, and appropriate acceptance criteria for release or stability testing) 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 electronic Common Technical Document (eCTD), the clinical 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 (GMPs); 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
• Support Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and Command Laboratories with developing Standard Operating Procedures (SOPs), pre-clinical protocols (toxicity and pharmacokinetics), Site Specific Procedures, validation and analytical methods.
• Conduct and lead (virtual and in-person) manufacturing site visits, generate site visit reports, document deficiencies and follow up with corrective actions to ensure Contract Manufacturing Organizations (CMO), Contract Research Organizations (CRO) are complaint with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Quality System Regulations (QSRs) in accordance with the Code of Federal Regulations (CFR) and International Conference on Harmonisation (ICH) guidelines and guidance documents.
• Experience in quality systems auditing in medical devices industry. Familiar with Medical devices 21 CFR 820 Quality Management System regulations
• This is a PART TIME position (20 hrs a week), and is located in Frederick, Maryland. It is a hybrid role, and you would be required to be on-site 2 days/week.

REQUIRED QUALIFICATIONS

• Bachelor’s Degree or the equivalent combination of education, professional training, or work experience.
• 5+ 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).

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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