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Drug Product Development Research Associate

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
May 17, 2022

View more

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

The drug product development team is seeking a highly motivated and creative associate to support drug product activities. The associate will primarily support formulation and process development activities including container closure and device studies and in use studies. The scientist will also work to develop new analytical techniques.

The candidate must have a Bachelors or Masters degree with coursework covering biological and/or health science subjects. Experience with analytical (biophysical) methods including particulate analysis, HPLC, and light scattering is preferred. Experience with characterization of AAV viral vectors and other non-viral gene therapies (e.g. lipid nano particles) is preferred. Experience with large datasets is required. Experience with biologics could be used

Responsibilities

Develop and use analytical methods to support experimentation and AAV characterization.

Use experimental methods and techniques to support formulation development

Support colleagues by assisting in setup and experimentation using automation tools.

Prepare presentations in various team and project meetings.

Prepare process development reports and technical documents

Education and Experience Requirements

    BS/MS degree in Pharmacy, biochemistry, biotechnology, biophysics, chemical engineering, biomedical engineering or related area. BS with 0-2 years of experience and/or MS with early career experience would be preferred. Experience with formulation development and/or analytical characterization of lipid nano particles-based gene therapies, AAV based gene therapies, mAbs and/or other biologics is strongly preferred. AAV, LNP experience is preferred. Experience with biologics (mAbs etc) may be considered as well. Academic experience on above may also be considered. Experience with analytical methods development (HPLC, Biophysical characterization, DLS, DSF, Particles etc) for formulation product characterization is required Experience working with large datasets is preferred Exposure to multivariate statistical analysis is preferred

Key Skills, Abilities, and Competencies

  • Strong organizational skills and detailed documentation abilities is required.
  • Able to quickly learn new skills and troubleshoot new problems
  • Work under supervision in hands-on laboratory setting, self-motivated to learn and develop new techniques
  • Perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
  • Excellent writing and verbal communication skills is required.
  • Teamwork is a must.
  • Must be comfortable in the fast-paced, multi-tasking biotech environment.
Complexity and Problem Solving

  • Clear communication and collaboration with multiple collaborators and stakeholders (automation, HTPD development, and formulation groups) will be required.
  • Organization, flexibility, and the ability to juggle multiple tasks in parallel (including sample testing and development projects).
  • Independent problem-solving skills during development of new analytical techniques, including develop solutions to a variety of moderate to complex problems.

Internal and External Contacts

  • HTPD Downstream and Formulation development team, to collaborate on development projects
  • PD Downstream and Formulation teams, to support sample and experimental testing as needed
  • Data science and statistical experts, who will support with data capture, organization, and data interpretation.

Other Job Requirements

Are there any other requirements such as below:

  • Must be able to lift 25 pounds
  • Must be able to wear appropriate clean room attire and all Personal Protective Equipment
  • Must be able to stand for long periods

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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