Analytical Development Scientist

Primary Duties

The Analytical Development Scientist plays a key role in analytical development team. He/she will design and execute experiments to develop/optimize analytical methods.

The analytical scientist will also support process and formulation development as needed, collaborate with analytical science, QC teams and external CDMO to develop SOPs and transfer the developed assays to the corresponding teams.

The major responsibilities are as follows, but not limited to:

• Develop new or optimize existing analytical release or characterization methods (CE or HPLC based) based on knowledge of biological and biochemical analytical techniques to support rAAV process development and product release/characterization.
• Write and edit internal technical reports, quality documents and external presentations.
• Troubleshoot technical issues and resolve the issues timely.
• Conduct analytical experiments to support process and technology development, and to deliver a reliable high-quality experimental data and prepare experimental reports in a timely manner.
• Manage critical samples and prepare critical assay reagents as needed.
• Maintain GXP compliant good documentation with high level of detail.

Responsibilities

• Working in the labs to perform experiments described above in the job primary duties
• Design experiments, organize, discuss and record experimental data.
• Prepare presenting materials, literature search and so on.
• Trainings, lab meetings and administration work

Education and Experience Requirements

• Ph.D in Biological sciences, or Analytical Chemistry or Biochemistry and 0-3 years of related experience, or B.S. degree and M.S, degree in Analytical Chemistry or Biochemistry and > 3-4 years biotechnology experience.
• Experience with viral vector production and characterization is preferred

Key Skills, Abilities, and Competencies

• Strong analytical skills and knowledge; familiar with variety of bio-separation lab techniques, including RP, SEC, IEX, HILIC, CE-SDS and cIEF with variety of detectors etc.
• Proven ability to work independently and collaboratively, self-motivated to learn and develop new techniques
• Capable of performing multiple tasks efficiently, keep accurate records, follow instructions, and comply with company policies.
• Good personal communication skills and team worker.
• Must be comfortable in the fast-paced, biotech start-up environment and interact with multi-disciplinary research teams at Spark.
• Knowledge of gene therapy is preferred, but not required.

Complexity and Problem Solving

• On a regular basis, the Analytical Development Scientist needs to work closely with the senior PD analytical team members and PD Analytical Lead to design and execute variety of experiments.
• Strong data organization skills, interpretation and troubleshooting are critical to success.
• New experiments should be designed based on available experimental data and scientific hypothesis and prediction and executed timely.

Internal and External Contacts

If needed, the Analytical Development Scientist may consult with internal resource to discuss scientific and technical issues, including QA/QC teams, R&D Operations, Technical Operations, PD/PSO teams; it is also needed, sometimes, to contact external experts, including vendors, to bring in and evaluate new technologies and instruments for evaluation purpose.

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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.