PD Upstream Scientist Gene Delivery

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

• Developing strategies to optimize efficacy and toxicity of non-viral gene delivery approaches.

• Synthesizing, characterizing, and evaluating novel formulations for nucleic acid delivery.
• Performing experiments in the development, optimization, and scale-up of recombinant adeno-associated viral vector (rAAV) production processes in suspension cell culture systems, with a focus on shaker flask, stirred tank bioreactor production at bench and pilot scales.
• Analyzing and interpreting experimental results; suggesting changes or additional experiments to improve the system performance, robustness and/or reproducibility.
• Participating in discussions regarding the troubleshooting of bench and pilot scale production processes and/or investigations; performing support studies as needed.
• Contributing to the evaluation and implementation of new technology development as appropriate.
• Participating in Technology Transfer from process development to manufacturing sites; assisting in training manufacturing staff as needed.
• Executing protocols, assembling data, and drafting appropriate technical documentation, which may include, but is not limited to SOPs and Process Development Reports.

The Process Development Scientist - Upstream position requires the following:

• The successful candidate will be skilled in formulation science, cell culture or engineering principles.
• He/she should have hands on experience in formulation or upstream process development, including familiarity and knowledge of formulation and gene delivery, capability for troubleshooting experiment and/or equipment issues, and ability to work/communicate effectively with fellow team members, as well as with project teams.

Responsibilities

Prepare protocols. Assemble experimental data and prepare data summaries.

Hands-on execution of experiments, reliably deliver results for the various development projects. Troubleshoot any experiment issues that arise.

Write and/or review technical process development reports and any other relevant process documentation (e.g., SOPs, Process Descriptions, etc.)

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.

Education and Experience Requirements

• Typically, has a Ph.D. in a relevant scientific discipline (e.g., pharmaceutical sciences, 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 life sciences/Biotech field.
• Knowledge or experience of formulation sciences is essential.
• Adept technical writing skills with experience authoring/reviewing technical documentation (protocols, reports, SOPs, etc.) is preferred.
• Familiarity with gene delivery and/or biomaterials is a plus.
• Strong understanding of the technical and equipment needs in a lab as well as significant hands-on experience with standard molecular and cell biology techniques such as ELISA, qPCR, cell culture, transfection, western blotting, etc. is a plus.
• Familiarity with statistical design/analysis software is a plus.

Key Skills, Abilities, and Competencies

• Experience and knowledge in general and advanced nanoparticle formulation techniques.
• Experience or knowledge with different characterization methods such as flow cytometry, dynamic light scattering and zeta potential.
• Proven ability to work independently in 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.
• Good scientific knowledge of cell and molecular biology, biochemistry, and formulation sciences.
• Capability in experimental design and data analysis, and experience troubleshooting.
• Ability to evaluate, refine, and implement new technology.
• Excellent written and verbal communication skills.
• Planning and organizational skills.

Complexity and Problem Solving

• 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.
• Must be comfortable in the fast-paced, biotech start-up environment and interact with multi-disciplinary Research, PD, and Tech Operations 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: R&D Operations, PD Downstream, PD Analytical, PCO, Technical Operations, Quality Assurance, Quality Control, Regulatory Affairs, Facilities, Materials Management, and Service Personnel/Vendors.
• External Vendors for the evaluation of new technologies, instruments and/or materials.
• External contact development and/or manufacturing organizations.
• 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.

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.