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Job Location: Philadelphia, PA
The Upstream Process Development Scientist is involved in the development, scale-up, optimization, technology transfer, characterization and validation of recombinant adeno-associated viral vector (rAAV) production processes. The Upstream Process Development Scientist executes experiments, develops production procedures and other relevant documentation, and works under supervision.
Job responsibilities are as follows:
- Plans procedural and experimental approaches to meet Process Development objectives.
- Cultures mammalian cells for viral production in shake flasks, spinner flasks, and/or bioreactors.
- Performs experiments in the development, optimization and scale-up of production processes; contributes to the development of recovery processes.
- Interprets experimental results; suggests changes or additional experiments to improve the robustness and/or reproducibility of the manufacturing process.
- Actively participates in discussions regarding the troubleshooting of manufacturing processes and/or investigations; performs supporting studies as needed.
- Participates in technology transfer from process development to manufacturing sites; assists in training manufacturing staff as needed.
- Participates in process characterization, and process validation activities.
- Establishes operating equipment specifications.
- Prepares and reviews process development protocols, data analysis summaries, technical reports, process descriptions, and other relevant process documentation.
- Maintains an accurate laboratory notebook.
- Ensures work conforms to applicable quality and safety standards.
- May participate in the development of patent applications.
- May participate on project teams.
- Other duties as assigned
- Plan/design experiments; prepare protocols for studies as needed.
- Execute laboratory experiments.
- Draft and/or review technical process development reports and any other relevant process documentation
- Attend meetings, prepare presentations, participate in training sessions, perform administrative duties.
- Expertise and hands-on experience in the development, scale-up, and technology transfer of cell culture production processes.
- Working knowledge of state-of-the-art principles, technologies, and instrumentation.
- Experience with production/manufacturing instrumentation is desired.
- Demonstrated ability to evaluate, refine, and implement new processes.
- Effective communication skills (verbal, written, interpersonal). Must be able to write protocols and technical reports.
- Must be able to interact with cross-functional teams.
- Analytical and problem-solving skills. Ability to simplify complicated processes.
- Ability to manage time effectively. Demonstrated planning and organizational skills.
- Proficiency in MS Office.
- Familiarity with statistical design/analysis software is a plus.
- Ph.D. in chemical engineering, chemistry, biochemistry, or molecular biology or related area and a minimum of 2-5 years of relevant scientific or technical experience in the life sciences industry; or equivalent. Experience in the development and scale-up of cell culture production processes is essential. Experience with viral vector production, and knowledge of recovery and purification process development is preferred.
WHO WE ARE:
Transforming Patients Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
How To Apply:
You will be directed to another website for application instructions.