The Bioanalytical Scientist I provides supervision of daily laboratory operations, offers guidance, leadership and direction to lab personnel to ensure on-time completion of customer projects. This includes leading initiatives for the transfer of newly developed assays that have been developed for customers to the company's Bioanalytical Lab, supporting new instrumentation intended for use in sample testing services and managing studies performed in accordance with relevant regulations. This pos... more details
POSITION SUMMARY:
The Bioanalytical Scientist I provides supervision of daily laboratory operations, offers guidance, leadership and direction to lab personnel to ensure on-time completion of customer projects. This includes leading initiatives for the transfer of newly developed assays that have been developed for customers to the company's Bioanalytical Lab, supporting new instrumentation intended for use in sample testing services and managing studies performed in accordance with relevant regulations. This position will directly supervise the work of others in their group and/or across interdisciplinary teams.
The Bioanalytical Scientist I will lead and/or direct the work of others, to include establishing the scope of work assignments, experiments and work schedules/deadlines. They are expected to independently manage multiple projects yielding high quality results, and provide oversight and guidance to other team members as needed.
DUTIES AND RESPONSIBILITIES:
Plan and oversee experiments performed in the Bioanalytical Laboratory utilizing appropriate protocols
Ensure resources (reagents, materials, equipment) are available and appropriate for intended use by lab personnel
Review documentation associated with executed projects including data capture, forms logbooks, and inventory batch records
Assist team members with interpreting results and troubleshooting technical issues
Verify the accuracy and validity of data; correct errors
Ensure that out-of-specification results or deviations from protocol are properly documented
Present laboratory management with summaries of troubleshooting efforts and conclusions
Direct 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.
Ensure that general lab maintenance initiatives are being performed and meet documented requirements
Verify electronic inventory databases, physical inventory and records of processing/aliquoting/vialing/labeling materials are accurate and up-to-date
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 other within the laboratory setting and provide guidance on best practices
This role supervises the work of others in all aforementioned areas of productivity and effectiveness
Responsible for supporting, mentoring and documenting performance evaluation for those they supervise
May be responsible for 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 preferred
Minimum of 7 years of work experience in an industrial setting is preferred; experience in a clinical or other regulatory environment is highly preferred; academic setting considered
Experience with protein based immunoassays, running antibody based assays, developing reagents and product development is desirable
Training and experience with Biosafety Level 2 (BSL-2) techniques is highly preferred
Minimum of one year of supervisory experience
KNOWLEDGE, SKILLS AND ABILITIES:
Strong scientific fundamentals and analytical background
Logical problem solving and demonstrated ability to initiate, organize and implement process improvement activities
Demonstrated 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 t technical challenges
Effective leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results
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
Ability to lift up to 25 pounds
PHYSICAL DEMANDS
Some work may be performed in the laboratory, and may involve repetitive tasks (e.g., pipetting)
Some lifting of up to 25 pounds
WORK ENVIRONMENT
Laboratory environment working with chemical reagents and performing some Biosafety Level 2 work
May involve handling BSL-2 materials and organisms including human blood and/or blood products
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