Req ID: RQ210374
Type of Requisition: Regular
Clearance Level Must Be Able to Obtain: None
Public Trust/Other Required: NACI (T1)
Job Family: Science and Research
Skills:
Clinical Trials,CMC Strategy,Documentations
Experience:
5 + years of related experience
US Citizenship Required:
Yes
Job Description:
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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The likely hourly rate for this position is between $46.17 - $57.50. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
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 50 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.
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Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
