QC Chemistry Analyst (NCI) Job in Maryland (MD), Research and Development Career, Full Time Jobs in Leidos Biomedical Research, Inc.
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QC Chemistry Analyst (NCI) job in FREDERICK

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Leidos Biomedical Research, Inc. jobs
Maryland (MD), FREDERICK
Job Code:  655874
Employer:  Leidos Biomedical Research, Inc.
Category:  Research and Development
Job Type:  Full Time

Country:  United States
State:  Maryland (MD)



The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.


Reporting into the QC Chemistry Manager, the QC Chemistry Analyst will:

- Conduct routine and non-routine analysis of raw materials, in-process, finished product, and stability samples according to standard operating procedures (SOPs)
- Coordinate sample shipments to client and outside testing labs
- Perform required data analysis, review data of moderate complexity, interpret data findings, investigate issues and report abnormalities, troubleshoots analytical methods
- Prepare and submit data summaries of moderate complexity for review
- Perform routine maintenance and troubleshooting on lab equipment
- Participate in out-of-specification investigations and recommend corrective actions
- Draft and revise SOPs
- Maintain the safety and orderliness of the lab
- Perform method transfer and qualification activities
- Follow good documentation practices to ensure appropriate documentation of test results
- May be required to work an occasional 2nd or 3rd shift and weekends as needed to support manufacturing activities
- Responsible for daily laboratory maintenance tasks
- Ensure compliance with SOPs, FDA, cGMP and GLP regulations



To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

- Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, a minimum of 2 years' job-related experience
- Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
- Ability to follow SOPs and comply with cGMP regulations
- Ability to perform a variety of analyses including computer-based instrumental analytical methods
- Working knowledge of a laboratory environment and equipment used for pharmaceutical analysis
- Experience working in a biopharmaceutical testing environment
- Experienced with wet chemistry techniques, chromatographic and spectroscopic testing
- Experience with raw material sampling and testing
- Good technical writing skills
- General knowledge of Biosafety Level 2 (BL2)
- Must be able to obtain and maintain a security clearance


Candidates with these desired skills will be given preferential consideration:

- Analytical instrument qualification
- Ability to develop analytical methods and generate SOPs
- Familiar with following USP monographs
- Use of electronic systems
- Ability to interface with Manufacturing, Quality Assurance, Materials Management

Expected Competencies:

- Intermediate professional role, responsible for delivery of professional activities while receiving a moderate level of guidance and direction
- Focuses on providing standard professional advice and creating initial reports/analyses for review by experienced team professionals
- Accountable for meeting own targets which impact the immediate work area
- Impact is generally limited to short-term team performance, occasionally on medium-term goals
- Beginning to have more of a contributory impact on team performance
- Requires knowledge and experience in own discipline and company policies, practices and procedures; still acquiring higher level knowledge and skills
- Determines a course of action based on guidelines and modifies processes and methods as required
- Uses previous experience, analysis and investigation, to identify the most appropriate option to solve a range of differing, but straightforward problems
- Understands and communicates complex information within the specialization or recognized body of formal knowledge
- In some instances, will need to convey information to audiences not knowledgeable of the subject matter

Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company's diverse employees support vital missions for government and commercial customers. 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. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.

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