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Analytical Development Scientist

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Jul 2, 2022

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Job Details

Primary Duties

The Analytical Development Scientist is a key member of Assay/Methodology development team. The selected candidate will apply existing knowledge to develop new analytical methods and optimize existing assays to support the development of novel gene therapy programs. She/he must be able to efficiently design and execute experiments, perform data analysis to support upstream and downstream process development. Participate in process characterization/validation work, collaborate with analytical science and QC teams to develop SOPs and transfer the developed assays to internal corresponding teams and external CRO.

The major responsibilities are as follows, but not limited to:

  • Develop new analytical methods to support process development and platform optimization on the efforts of removing empty capsids and DNA impurities in rAAV products.
  • Serve as SME for analytical method transfer to QC and CRO.
  • Design and conduct analytical experiments to support process and technology development, and to deliver a reliable high-quality experimental data and prepare experimental reports in a timely manner.
  • Understand regulatory expectation, write, review, edit, and approval internal technical reports, quality documents and external presentations.
  • Provide analytical expertise to troubleshoot issues and resolve the issues timely
  • Demonstrate proficiency with biological and biochemical analysis techniques (protein analysis methods and qPCR/ddPCR-based assays) for biotherapeutic characterization
  • Maintain GXP compliant good documentation with high level of detail.

Responsibilities

  • Working in the labs to perform experiments described above in the job primary duties
  • Design experiments, organize, discuss and record experimental data.
  • Prepare presenting materials, literature search and so on.
  • Trainings, lab meetings and administration work

Education and Experience Requirements

  • Ph.D in a relevant scientific discipline such as biological sciences, biochemistry, or analytical chemistry. Or BS/MS degree in a relevant scientific discipline with at least 3 years of applicable experience.
  • Experience with viral vector production and characterization is preferred

Key Skills, Abilities, and Competencies

  • Strong analytical skills and problem-solving capabilities; Expert skills in a variety of lab techniques, including protein assay methods and qPCR/ddPCR-based assays.
  • Proven ability to work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques
  • Demonstrated ability to collaborate with team and to train junior staff
  • Excellent organizational, record keeping, communication skills, strong technical writing skills
  • Flexible and comfortable with a fast-paced and evolving business environment
  • Demonstrates Spark values, especially Commit to Collaboration and Demonstrate the Respect you Seek

Complexity and Problem Solving

  • Refers to policies and established procedures for guidance
  • Strong technical expertise and capable to identify, resolve, and/or advise on technical issues related to assay development and procedures of protein analysis and qPCR/ddPCR based assays
  • Develops solutions to a variety of problems of moderate scope and complexity
  • Plan daily work schedule to complete tasks efficiently
  • Work is generally performed independently, with moderate direction
  • Work is reviewed for soundness of judgement and overall adequacy and accuracy

Internal and External Contacts

  • Serves as SME for AD technical discussions
  • Represent group/department on specific projects
  • May participate/present at relevant scientific conferences and contribute to publications
  • Communicates and coordinates with external vendors
  • Attend scientific conferences or symposia; may present when possible

#LI-2326

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.


Nearest Major Market: Philadelphia



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.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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