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Scientist, Drug Product Development

Date: Feb 22, 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.

 

 

The drug product development team within the process and technology development organization at Spark is seeking a highly motivated Scientist. Spark has paved the way for gene therapies and is a recognized leader in the transformational field. As a member of our dedicated process development function, the scientist will play a key role in supporting early and late-stage drug product development activities. This position will require project responsibilities on several key aspects of drug product development including formulation, process, container closure and device, raw materials etc.

 

- Drug product development, i.e. formulation and fill/finish process development (including in-use and administration, container closures and device and raw material aspects) of early and late stage gene therapy projects. The scientist will also support commercial projects and/or life cycle projects as needed

- Designing and execution of studies to support formulation, process development (including lyophilization process development), E&Ls and compatibility and in use and administration studies. Lead identification, designing and execution of administration device (large molecule parenteral devices) studies

- Manage designing and execution of analytical biophysical characterization and high throughput formulation development and screening

- Collaborate and work with cross functional teams (e.g. with analytical development, drug substance, CMC, clinical etc). Prepare and present (e.g. data) as needed

- Support downstream process development (including for successful DP process and formulation development)

- Support external/ internal manufacturing process and participate troubleshooting and investigations

- Ensure compliance with Spark procedures and good practices (e.g. documentation)

 

Responsibilities

10%       Design and analyze the experiments

20%       Write/review protocols, reports and tech transfer documents

20%       Meet, prepare and present

60%       Execution in the lab to perform experiments described above in the job primary duties

 

Requirements

  • Ph.D. in biochemistry, pharmaceutics, chemical engineering, material sciences, mechanical engineering or related discipline with 0-2 years of industry experience or MS with around 4-6 years of industry experience or BS with 6-8 years of experience is required. Experience/background in large molecule drug product development (formulation and/or process), material sciences, and/or container closures and devices (parenteral administration) development is preferred.

 

  • Experience/background knowledge in large molecules development i.e. gene therapies (RNA LNPs, AAVs), vaccines, cell therapies, and/or biological molecules is strongly preferred. Experience on related sterile parenteral products may be considered.

 

  • Experience with rAAV is plus.

 

  • Experience/background with in-use administration and delivery approaches to sterile parenetrals is a strong plus

 

  • Understanding/background of Freeze Drying/ Lyophilization of biologics is plus.

 

  • Experience/background knowledge of high throughput formulation development, analytics and biophysical characterization, setting up high throughput and automation/programming platforms as they relate to biopharma development is a plus

 

  • Experiences/background-knowledge of large scale GMP manufacturing and GXP compliant documentation is plus.

 

Competencies

  • Good scientific publication record and/or patent filing is plus.

 

  • Organizational skills and documentation abilities is required.

 

  • Should be adaptable/flexible and able to work independently and in teams as needed

 

  • Strong writing and verbal communication skills is required

 

  • Demonstrate independent problem-solving skills of technical issues


Nearest Major Market: Philadelphia