Drug Product Development Research Associate

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.