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Bioanalytical Scientist

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Oct 1, 2022

View more

Discipline
Health Sciences, Drug Development
Job Type
Staff Scientist
Organization Type
Pharma
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Job Details

Primary Duties

The Bioanalytical Scientist will be part of the Translational Bioanalytics Group, supporting multiple non-clinical and clinical studies in a regulated environment for advancing gene therapy programs across all therapeutic areas. The Bioanalytical Scientist will conduct various bioanalytical assays, such as immunoassay, anti-drug antibody, enzymatic activity, and biomarker assays under the guidance and supervision of the manager.

The Bioanalytical Scientist is responsible for:

  • Plan and perform optimization or development of new bioanalytical assays; primarily assays for protein levels or activity
  • Perform and/or provide oversight of method qualification and validation of bioanalytical assays following regulatory guidelines
  • Conduct and/or provide oversight of non-clinical and clinical sample analysis following standard operating procedures (SOPs) and regulatory guidelines
  • Perform data analysis using basic and advanced software
  • Maintain accurate, timely, and detailed records of all experimental work in accordance with Good Documentation Practices (GDP) and SOPs
  • Collaborate with and provide training to junior scientists
  • Author and review technical documents, protocols, reports, and SOPs
  • Assist in equipment maintenance and calibration in accordance with GDP and SOPs
  • Reagent sourcing, receipt, storage, inventory, preparation, and qualification

Responsibilities

Hands-on laboratory work supporting development, optimization, qualification/validation of bioanalytical assays

Hands-on laboratory work supporting sample testing and reporting

Maintain and review GDP documentation for all experimental work

Prepare and review technical documents, protocols, reports, and SOPs

Train and mentor junior scientists and associates

Perform and/or monitor equipment maintenance/calibration

Reagent ordering, receipt, storage, inventory, preparation, and qualification

Maintain updated safety, compliance, and SOP training

Education and Experience Requirements

  • PhD, BS or MS in relevant scientific discipline (molecular biology, biochemistry, immunology, cellbiology, etc.)
  • Minimum of 3 years bioanalytical experience, preferably with immunoassay, anti-drug antibody, enzymatic, and/or biomarker assays
  • Understanding of GLP and regulatory guidance for bioanalytical assay validation and sample testing

Key Skills, Abilities, and Competencies

  • Hands-on experience in assay development, optimization, qualification/validation of bioanalytical assays is required; experience obtained in a pharmaceutical environment is preferred
  • Understanding of GDP and GLP is required
  • Strong organizational, communication, and writing skills
  • Ability work independently as well as possess self‑motivation, adaptability, and a positive attitude
  • Detail oriented with a desire to produce high-quality results

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.

Learn more about Spark Therapeutics and view other openings.

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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