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Drug Product Development Scientist

Employer
Spark Therapeutics
Location
San Francisco, California
Salary
Salary not provided
Closing date
May 15, 2022

View more

Sector
Pharmaceutical
Organization Type
Corporate
Jobseeker Type
Professional
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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 preclinical, 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 (fill-finish), container closure, device, administration etc. The candidate must have biopharmaceutical industry (biologics) experience to develop, optimize, and characterize drug product (especially formulation and process development).

Responsibilities

- 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 sr scientist will also support commercial projects and/or life cycle projects as needed

- Lead (individually or a team) 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

- Manage technical transfer activities to internal or external manufacturing DP sites. Engage in evaluation of new sites
- Lead and represent DP on cross functional teams and manage projects (e.g., with analytical development, drug substance, CMC, clinical etc). Prepare and present as needed

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

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

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

- May supervise and/or lead people (depends on experience and level)

% of Time

Job Function and Description

20%
Lead design and analysis of experiments

20%
Writing protocol, reports, tech transfer documents etc

40 %
Meetings, representing, preparing, presenting, leadership, tech dev etc

20%
Execution and support in lab

10%
Strategy
Education and Experience Requirements
  • Ph.D. in biochemistry, pharmaceutics, chemical engineering, or related discipline with 1-4years of meaningful industry experience or MS with over 6-9 years of industry experience or BS with 9-12 years of experience in drug product development (formulation/process) is strongly preferred

  • Experience in formulation and/or fill/finish process development for large molecule parenteral products 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 preferred.

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

  • 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 strongly preferred

  • 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 preferred.


Key Skills, Abilities, and Competencies
  • Strong scientific publication record and/or patent filing is preferred. Strong fundamental understanding in biophysics of large molecules (colloidal particles) is preferred

  • Strong organizational skills and documentation abilities is preferred.

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

  • Excellent writing and verbal communication skills is required

  • Demonstrate independent problem-solving skills of technical issues

Complexity and Problem Solving
  • Clear communication and collaboration with multiple collaborators will be required.
  • Organization, flexibility, and the ability to juggle multiple tasks in parallel.
  • 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
  • CMC functions: AD, DP, DS
  • Manufacturing
  • CRO/CMO
  • Regulatory

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.
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