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Bioanalytical Associate II at Meso Scale Diagnostics LLC in Gaithersburg, Maryland

Posted in Other 7 days ago.

Type: Full Time





Job Description:

POSITION SUMMARY:

A Bioanalytical Associate II 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 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:

* Execute assigned experiments with minimal guidance 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

* Exercise professional judgment to independently analyze experiment data utilizing validated analytical procedures

* 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-specificatio n results, or deviations from protocol

* Support efforts for qualification of materials and lot concordance, lot bridging studies, and transfer of newly developed assays/platforms for routine testing in a regulated environment

* Lead general lab maintenance initiatives including maintaining laboratory supplies and equipment

* Log associated maintenance activities in accordance with documented requirements

Maintain electronic inventory data bases , physical inventory and records of processing/aliquoting/vialing/labeling materials

Prepare, maintain and report reagent inventories for assigned methods

* 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

* Specific duties may vary depending upon departmental requirements

EXPERIENCE AND QUALIFICATIONS:

* Bachelor's degree in life sciences, protein sciences, cellular/molecular biology, chemistry, bioche mistry , biotechnology, or other related area is required. Master's degree desirable.

Minimum 3 years of work experience (excluding academic internships) in reagent or assay development in an industrial setting is preferred; academic setting considered

* Training in and experience with Biosafety Level 2 (BSL-2) techniques is highly preferred Experience with running antibody-based assays, developing reagents and products is desirable

KNOWLEDGE, SKILLS AND ABILITIES:

* Strong scientific fundamentals and analytical background

* Demonstrate understanding and ability to execute assays in a high-th roughput environment with attention to detail and a focus on high-qualit y 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

* Proficiency in MS Office suite; familiarity with electronic file management using SharePoint (end user minimum) and MS Excel is necessary

* Ability to multi-task in an environment with changing priorities

* Ability to lift up to 25 lbs

PHYSICAL DEMANDS:

Up to 75 % of the day may be spent at a lab bench, and may involve repetitive tasks (e.g ., pipetting).

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.