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Bioanalytical Scientist

Date: Apr 21, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

Primary Duties

 

The Bioanalytical Scientist position requires a background and hands-on experience in developing, validating, and implementing complex molecular, enzymatic and immunoassays independently or in collaboration with senior personnel. The selected candidate will apply existing knowledge and regulatory guidance to new assays and methods to support the development of gene therapy products across all therapeutic areas.  The Bioanalytical Scientist will report to the Bioanalytical Testing Lead.

 

The candidate, under the guidance and supervision of senior scientists, must be able to develop and execute experiments, perform data analysis, and collaborate effectively with other scientists.  The candidate must be able to work independently and as part of a team and possess self-motivation and show adaptability.

 

The Bioanalytical Scientist is responsible for:

  • Assisting in the planning, development, and optimization of bioanalytical assays such as quantitative PCR assays, ELISA, and enzymatic assays in support of gene therapy studies
  • Performing method qualification and validation of bioanalytical assays such as quantitative PCR assays and immunoassays following regulatory guidelines to support non-clinical and clinical studies
  • Conducting preclinical and clinical sample analysis in accordance with standard operating procedures and generate data with high scientific quality to meet GDP/GLP expectations
  • Participating in reagent sourcing, storage, and qualification
  • Performing data analysis using basic and advanced software
  • Preparing technical documents, protocols, reports, and standard operating procedures
  • Maintenance, calibration, and documentation of laboratory equipment

 

Responsibilities

 

% of Time

Job Function and Description

30%

Hands on assay development, optimization, and execution

30%

Qualification, validation, and implementation of the assays for sample analysis

20%

Sample analysis and reporting

20%

Preparing technical documents, protocols, reports, and standard operating procedures

 

Education and Experience Requirements

 

  • PhD in relevant scientific discipline (molecular biology, biochemistry, immunology, cell biology, etc.)
  • Minimum 3 years of hands-on experience in qPCR, immunoassays, and/or enzymatic assays in pharmaceutical and/or academic environment
  • Experience with digital PCR is desired
  • Understanding of GLP and regulatory guidance on bioanalytical assay validation and sample testing is desired
  • Experience with preparing technical documents, protocols, reports, and standard operating procedures

 

Key Skills, Abilities, and Competencies

.

The position requires hands-on experience in assay development, qualification, and validation of bioanalytical assays. Ability to learn new techniques and show adaptability is essential.  Excellent organizational and communication skills are necessary.

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Nearest Major Market: Philadelphia