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Sr 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 Senior 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 sr. scientist will play a key role in supporting and leading early and late stage drug product development activities. This position will require project accountabilities and responsibilities on several key aspects of drug product development including formulation, process, container closure and device etc. The candidate must have biopharmaceutical industry experience to develop, optimize, and characterize drug product (especially formulation and process development).

 

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

- Lead, designing and execution of studies to support formulation, process development (including lyophilization process development), E&Ls and compatibility and in use and administration studies

- Manage and/or lead design and execution of analytical biophysical characterization and high throughput formulation development and screening

- Lead and represent DP on cross functional teams and manage projects (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

20%                     Design and analyze the experiments      

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

20-30%               Lead , meet, prepare and present

30-40%               Execution in the lab to preform experiments described above in the job primary duties

 

Requirements

  • Ph.D. in biochemistry, pharmaceutics, chemical engineering, or related discipline with 3-5 years of meaningful industry experience or MS with over 6-8 years of industry experience or BS with 8-10 years of experience in drug product development (formulation/process) is required

 

  • Experience in formulation and/or fill/finish process development for large molecule parenterals i.e. gene therapies (RNA LNPs, AAVs), vaccines, cell therapies, and/or biological molecules is required. Experience on related sterile parenterals may be considered. Experience with rAAV is preferred.

 

  • Experience on cryopreservation is a plus. Good understanding of Freeze Drying/ Lyophilization of biologics is plus.

 

  • Experience with high throughput formulation development is preferred. Experience in large molecule analytics and biophysical characterization is preferred. Experience on setting up high throughput and automation/programming platforms as they relate to biopharma development is a plus

 

  • Some experience of container closures and devices and raw materials as it relates to large molecules is preferred

 

  • Experiences of large scale GMP manufacturing and GXP compliant documentation is plus.

 

Competencies

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

 

  • Strong 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