Plasmid Vector Engineering Lead Scientist - Upstream PD

The Lead Process Development Scientist – Vector Engineering is a key member of the vector engineering development team within the Upstream PD Group. He/she will be responsible for:

• Applying QbD and risk-based approaches to the vector engineering development initiatives, which will include development and characterization of plasmid vectors used for AAV production, and development and characterization of plasmid research cell banks.
• Leading platform design efforts of plasmid backbone to improve productivity and quality of viral vectors produced by transient transfection.
• Designing optimized and characterized plasmids, and robust manufacturing processes to produce plasmids suitable for future clinical and commercial production
• Overseeing the development, optimization, clinical production, and technology transfer of plasmid E. coli cell banks to GMP facilities
• Establishing plasmid DNA manufacturing technical specifications and the associated analytics for in process characterization and testing for new clinical programs.
• Preparing detailed process development reports to support manufacturing and regulatory requirements per ICH guidelines.
• Designing and executing experiments in High-Throughput platforms and shake flask for the development or optimization of upstream rAAV processes with knowledge of DoE design and statistics.
• Overseeing transfer of new plasmid vectors to the Upstream suspension cell culture team for proof-of-concept studies at benchtop bioreactor scale.
• Analyzing and interpreting experimental results; suggesting changes or additional experiments to improve plasmid and rAAV vector development efforts.
• Participating in discussions regarding the troubleshooting of processes and/or investigations; and performing/leading supporting studies as needed.
• Contributing to the evaluation and implementation of new technology development in plasmid and rAAV manufacturing.
• Collaborating with cross-functional department colleagues within Spark and external partners to ensure the successful execution of Spark’s strategies and company objectives.
• Aligning process development vector engineering support for plasmids for gene therapy clinical programs with research teams, viral production core, plasmid production group, and manufacturing/operations teams.
• Ensuring strong strategic partnerships & communication with colleagues from Research groups, Technology and Process Development groups, Analytical, and Manufacturing (internal and external partners, CMOs), External Project Management, Regulatory Affairs, and Quality.

The Vector Engineering Lead Scientist – Upstream PD position requires the following:

• The successful candidate will have in-depth familiarity and knowledge of plasmid and cell bank development and characterization, and ICH guidelines.
• Strong project leadership & strong industry knowledge and experience in plasmid engineering, development, and characterization.
• Experience in developing relationships with external vendors and CROs
• Experience mentoring junior scientists

Responsibilities

Describe the essential daily job functions and include % of time spent on each.

% of Time

Job Function and Description

30%

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 author technical reports.

50%

Hands-on execution of experiments on the bench, deliver reliable experimental results for the various cell line development projects. Troubleshoot any issues that arise.

20%

Manage raw material/instrument supplies to ensure efficient cell line development activities. Prepare documents/presentations/materials for meetings, conferences and/or publications. Attend internal meetings, participate in training sessions, perform administrative duties.

Education and Experience Requirements

• Ph.D. in relevant scientific or engineering field (e.g., microbiology, molecular biology, chemical engineering, virology, biochemistry, etc.) with at least 3+ years of applicable experience or BS/MS in relevant scientific discipline with 8+ years of applicable experience.
• Strong background in bacterial culture, bacterial genetics, bacterial plasmid cloning, plasmid DNA development and associated molecular techniques is preferred
• Experience with development and optimization of plasmid manufacturing processes
• Experience with plasmid manufacturing and the associated analytics for in process characterization and testing is preferred
• Experience in aseptic mammalian cell culture, viral production, next-generation sequencing (NGS) and quantitative PCR methods a plus
• Familiarity with statistical design/analysis software and digital proficiency is a plus.

Key Skills, Abilities, and Competencies

• Good scientific knowledge of bacterial culture, bacterial plasmid cloning, and associated

molecular biology techniques

• Proven track record of applying molecular biology techniques in plasmid design and optimization
• Strong capability in experimental design and data analysis, with a proven record of

troubleshooting.

• Proven ability to evaluate, refine, and implement new processes.
• Excellent written and verbal communication skills.
• Demonstrated planning and organizational skills.

Complexity and Problem Solving

• Demonstrate independent problem-solving skills when faced with technical issues; capable of working on multiple tasks and developing solutions for a variety of highly complex problems. Discuss with supervisor and refer to policies/practices for guidance.
• Must be comfortable in the fast-paced, biotech start-up environment and interact with multi-disciplinary Research, PD, Tech Operations, Manufacturing, Analytical and Quality teams at Spark.
• Exercise judgment within defined procedures and practices to determine appropriate action.

Internal and External Contacts

• Fellow Upstream PD Team Members to discuss scientific and technical issues
• Cross-functional Team Members such as: PD Downstream, PD Analytical, PCO, Technical Operations, Quality Assurance, Quality Control, Regulatory Affairs, R&D Operations, Facilities, Materials Management, and Service Personnel/Vendors.
• CROs for the manufacture of GMP cell banks and plasmid material.
• External Vendors for the evaluation of new technologies, instruments and/or materials.

Other Job Requirements

• 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.
• Although infrequent, some travel may be required.

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.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.

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.

Learn more about Spark Therapeutics and view other openings.