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Upstream Process Development Scientist
Job Opportunity at
Spark Therapeutics, Inc
Posted on Apr 19
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 Patient’s 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.
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