Bioanalytical Associate III
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 Gaithersburg, MD

Requisition Number: BIOAN01411

POSITION SUMMARY:

The Bioanalytical Associate III is responsible for independently executing experiments and analyzing the resulting data in support of Bioanalytical sample testing service projects. This is a laboratory based position performing protein-based immunoassays on a routine basis with relatively high throughput (3-10 plates per day).The Bioanalytical Associate III is expected to be able to manage multiple projects with high quality results, and provide oversight and guidance to other team members as needed. The incumbent is expected to adhere to all standard operating procedures and policies established for execution of Bioanalytical studies and sample testing projects under applicable regulatory compliance requirements.

DUTIES AND RESPONSIBILITIES:

  • Independently execute planned experiments utilizing appropriate protocols
    • Organize and procure needed reagents, perform experiments, and analyze data
    • Complete documentation associated with specified testing procedures including data capture, forms, logbooks, and inventory batch records
  • Independently analyze experiment data utilizing validated analytical procedures, and assist team members with interpreting results and troubleshooting issues
    • Employ self-reliance in drawing experiment conclusions and interpreting results
    • Initiate the verification of accuracy and validity of data; correct any errors
    • Document and report any out-of-specification results, or deviations from protocol
    • Present laboratory management with summaries of troubleshooting efforts and conclusions
  • Lead efforts supporting qualification of materials and lot concordance, lot bridging studies, and transfer of newly developed assays/platforms for routine testing in a regulated environment.
  • Participate in general lab maintenance initiatives including maintaining laboratory supplies and equipment
    • Log associated maintenance activities in accordance with documented requirements
    • Maintain electronic inventory databases, physical inventory and records of processing/aliquoting/vialing/labeling materials
  • Utilize self-reliance in understanding and adhering to laboratory safety precautions and proper use of personal protective equipment
    • Projects may require running assays with Biosafety Level 2 (BSL-2) samples such as human serum and plasma
    • Bioanalytical personnel should feel comfortable handling or being trained to handle BSL-2 samples and work in a Biological Safety Cabinet
    • The incumbent is also expected to monitor the behaviors of others within the laboratory setting and provide guidance on best practices
  • Incumbents may be required to develop and implement SOPs as well as participate as a team member in developing new documentation for the department
  • This role may supervise individual runs by more junior analysts and provide training and development of laboratory personnel
  • Specific duties may vary depending upon departmental requirements

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in life sciences, protein sciences, cellular/molecular biology, chemistry, biochemistry, biotechnology, or other related area is required
    • Master’s degree is preferred
    • Additional experience may be substituted for Master’s degree
  • Minimum 5 years of work experience in reagent or assay development in an industrial setting is preferred; academic setting considered
  • Experience with protein based immunoassays, running antibody-based assays, developing reagents and product development is desirable
  • Training in and experience with Biosafety Level 2 (BSL-2) techniques is highly preferred
  • A demonstrated level of consistency in performance and aptitude for managing additional responsibility and accountability are required for next level consideration

KNOWLEDGE, SKILLS AND ABILITIES:

  • Strong scientific fundamentals and analytical background
    • Logical problem solving and demonstrated ability to initiate, organize and implement process improvement activities
  • Demonstrate understanding and ability to execute and oversee assays run in a high-throughput environment with a focus on high-quality results. Ability to troubleshoot issues and provide solutions to technical challenges.
  • Excellent interpersonal skills and ability to work well with personnel at all levels
    • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
    • Effectively communicate performance goals and expectations
  • Proficiency in MS Office suite; familiarity with electronic file management using SharePoint (end user minimum) and MS Excel is necessary
  • Ability to multi-task and work productively in a demanding environment with changing priorities

PHYSICAL DEMANDS:

  • Up to 60 % of the day may be spent at a lab bench, and may involve repetitive tasks (e.g., pipetting)
  • Ability to lift up to 25 lbs

WORK ENVIRONMENT:

  • Laboratory environment working with chemical reagents and performing some Biosafety Level 2 work
    • May involve handling of BSL-2 materials and organisms including human blood and/or blood products
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