Lead Process Development Scientist - Upstream

Company: Spark Therapeutics
Location: Philadelphia
Posted on: February 25, 2021

Job Description:

Lead Process Development Scientist - Upstream 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. The Lead Process Development Scientist - Upstream is a key member of the upstream bioreactor team within the Upstream PD Group. He/she will be responsible for:

• Applying quality-by-design and risk-based approach to the development of recombinant adeno-associated viral vector (rAAV) production processes that are robust, reproducible and scalable up to and --- 200L.
• Planning and performing experiments in the development, optimization and scale-up of rAAV production processes in suspension cell culture systems, with a focus on stirred tank bioreactor production.
• Conducting rAAV production studies in shake flasks, stirred tank bioreactors, AMBR systems, etc.
• Addressing complex production process challenges by demonstrating and applying cross-functional knowledge with a keen understanding of industry best operating procedures and regulatory expectations.
• 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.
• Designing and executing protocols, assembling data and drafting appropriate technical documentation, which may include, but is not limited to SOPs and Process Development Reports. The Lead Process Development Scientist - Upstream position requires the following:
  • The successful candidate will be skilled in suspension cell culture, stirred tank bioreactor operation including batch, fed-batch and perfusion modes, principles of stirred tank bioreactor scale-up to --- 200L, and scale-down model definition.
  • He/she should have hands on working experience in upstream process development, including in-depth familiarity and knowledge of production processes, capability for troubleshooting process and/or equipment issues, and ability to work/communicate effectively with fellow team members, as well as with project teams. Responsibilities 20% Play a lead role in the planning/prioritization of projects, balancing in-house work and outsourced work/activities. Design experiments, prepare protocols, and ensure execution of said experiments. Assemble experimental data and prepare data summaries. 50% Hands-on execution of experiments on the bench, deliver reliable experimental results for the various development projects. Troubleshoot any issues that arise. 20% Write and/or review technical process development reports and any other relevant process documentation (e.g. SOPs, Process Descriptions, etc.) 10% Manage raw material/instrument supplies to ensure efficient and timely upstream operations. Prepare documents/presentations/materials for meetings, conferences and/or publications. Attend internal meetings, participate in training sessions, perform administrative duties. Requirements
    • Typically, has a Ph.D. or master's degree in relevant scientific discipline (e.g. chemical engineering, molecular biology, virology, biochemistry, etc.).
    • Generally, has 8+ years of relevant scientific and/or technical experience in the life sciences/Biotech industry.
    • Hands on experience in upstream process development with suspension cell culture in shake flasks, Ambr15/250, rocker-style bioreactors and/or benchtop stirred tank bioreactors is essential.
    • Experience in scaling-up suspension cell culture stirred tank bioreactor production processes to --- 200L is essential. Experience in scale-down model qualification is a plus.
    • Adept technical writing skills with experience authoring/reviewing protocols, reports, SOPs, and batch records 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 viral vector production is preferred.
    • Experience with development and optimization of cell culture media and/or feeding strategies in bioreactors is a plus.
    • Familiarity with statistical design/analysis software is a plus. Spark Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Spark Therapeutics does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Spark Therapeutics from recruiters do not constitute any type of relationship between the recruiter and Spark Therapeutics and do not obligate Spark Therapeutics to pay fees if we hire from those resumes. Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Please reach out to Accomodations@sparktx.com if you require reasonable accommodations.

Keywords: Spark Therapeutics, Philadelphia , Lead Process Development Scientist - Upstream, Other , Philadelphia, Pennsylvania