Job Abstract

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