The Upstream Cell Culture Process Development group is seeking a highly motivated Cell Culture Process Development Scientist. S/he will be a key member of the cell culture bioreactor team and will develop and implement processes to support process development, control, and robustness efforts in Spark’s gene therapy drug substance modality. She/he will:

• Performing experiments in the development, optimization, characterization, and scale-up of recombinant adeno-associated viral vector (rAAV) production processes in suspension cell culture systems, with a focus on stirred tank bioreactor production up to and 200L.
• Conducting rAAV production studies in shake flasks and stirred tank bioreactors from AMBR to commercial pilot scale.
• Assisting in addressing production process challenges by applying cross-functional knowledge with an understanding of industry best operating procedures.
• Analyzing and interpreting experimental results; suggesting changes or additional experiments to improve the robustness and/or reproducibility of the production process.
• Participating in discussions regarding the troubleshooting of production processes and/or investigations; performing supporting studies as needed.
• Contributing to the evaluation and implementation of new technology development.
• Participating in Technology Transfer from process development to manufacturing sites; assisting in training manufacturing staff as needed.
• Authoring and executing protocols, assembling data, and drafting appropriate technical documentation, which may include, but is not limited to SOPs and Process Development Reports.
• Maintaining an accurate laboratory notebook following ALCOA+ principles.
• Participate on Pipeline and/or Technology Platform project teams as a contributing member.

The Process Development Scientist - Upstream position requires the following:

• The successful candidate will be skilled in suspension cell culture and stirred tank bioreactor operation.
• He/she should have hands on working experience in upstream process development, including familiarity and knowledge of bioreactor production processes, capability for troubleshooting process and/or equipment issues, and ability to work/communicate effectively with fellow team members, as well as within project teams.

Responsibilities

• Design and execute experiments, deliver results for studies in support of objectives. Troubleshoot any experiment issues that arise.
• Author technical process development protocols and reports and any other relevant process documentation (e.g., Process Descriptions, PD Data Summaries, etc.)
• Attend internal and external meetings, participate in training sessions, perform administrative duties. Prepare documents/presentations/materials for meetings.

Education and Experience Requirements

• Ph.D. in a relevant scientific discipline (e.g., chemical engineering, biological engineering, molecular biology, virology, biochemistry, etc.) or a B.S./M.S. in a relevant scientific discipline with 3+ years of relevant scientific and/or technical experience in the Bioprocessing field.
• Hands on experience in upstream process development with aseptic suspension cell culture methods in shake flasks and stirred tank bioreactors is essential.
• Adept technical writing skills with experience authoring/reviewing technical documentation (protocols, reports, SOPs, etc.) is essential.
• Experience in Technology Transfer of suspension cell culture stirred tank bioreactor production processes from Process Development to cGMP receiving entities (internal MFG, CDMO, CMO, etc.) is preferred.
• Experience with ambr250ht, ambr15, and/or BioFlo bench-scale bioreactors is preferred.
• Experience with development and process optimization in bioreactors is a plus.
• Familiarity with statistical design/analysis software and digital proficiency is a plus.
• Familiarity with bioreactor harvest operations including filtration is a plus.
• Familiarity with AAV or viral vector production is preferred.

Key Skills, Abilities, and Competencies

• Proven ability to work independently in a 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.
• Self-motivated, fast learner and driven to innovate with problem solving mindset
• Excellent written and verbal communication skills.
• Demonstrate problem-solving skills when faced with technical issues; capable of working on more than one task and developing solutions for moderately complex problems. Discuss with supervisor and refer to policies/practices for guidance.
• The Upstream Scientist is expected to work with the Upstream Process Development Team in designing and executing experiments, interpreting results, and performing any necessary troubleshooting.
• Must be comfortable in a fast-paced environment and interacting with multi-disciplinary Research, Process Development, and Tech Operations teams at Spark.
• Must be able to lift 25 pounds.
• Due to the inherent nature of cell culture, some weekend work and/or work on holidays may be needed. On occasion, long work hours may be required depending upon the experiment schedule.
• Handling large volumes of cell culture or related materials, such as tens of liters, may be required.
• Some travel may be required for Tech Transfer, training, and conference attendance.