The Process Development Scientist – Cell line Development and Molecular AAV Engineering is involved in the execution of recombinant adeno-associated viral vector (rAAV) production processes. The Cell line Development and Molecular AAV Engineering Scientist executes experiments, develops production procedures and other relevant documentation, and works under supervision. This position requires experience with molecular biology, biochemistry, and gene expression analyses. He/she will be responsible for:
- Implementing plasmid engineering strategies to develop improved AAV production for gene therapy purposes.
- Participating in and/or overseeing process development programs, facilitating translation from small scale to large scale AAV production in support of current and future therapeutic programs.
- Collaborating with other Process Development Scientists at Spark to design and conduct in vitro studies to optimize development of expression vectors
- Participating in joint programs and collaborations with external parties.
- Writing study reports, manuscripts and presenting results at appropriate scientific meetings.
- Designing, executing and analyzing data related to experimental studies utilizing in vitro models.
- Culturing mammalian cells for viral production in shake flasks, spinner flasks, spin tubes and/or benchtop bioreactors.
- Performing experiments in the development, optimization and scale-up of pre-packaging/ packaging/producer cell line.
- Analysis and characterization of new engineered cell lines and stability studies.
- Preparing and reviewing process development protocols, data analysis summaries, technical reports, and other relevant process documentation.
- Optimization of transfection and transduction protocols for newly engineered cell lines.
- Maintaining an accurate laboratory notebook.
- Ensuring work conforms to applicable quality and safety standards.
- Participating in the technology transfer from process development to manufacturing sites (as needed).
- Training colleagues on various experimental assays
- Participating on project teams (as needed).
- Familiarity with gene therapy and/or AAV is preferred but not required.
- Other duties as assigned.
Perform laboratory support work and execute laboratory experiments.
Analyze data from experiments and draft presentations.
Draft protocols for studies and the subsequent technical reports as needed.
Attend meetings and perform administrative duties as needed.
Education and Experience Requirements
Key Skills, Abilities, and Competencies
- Ph.D. in chemical engineering, chemistry, biochemistry, or biology/molecular biology or related area.
- Generally, has at least 2 years of relevant scientific or technical experience in the life sciences industry or equivalent.
- Experience in cell culture including materials, instruments and technologies is essential.
- Experience with viral vector production is preferred.
- Experience in general and advanced lab techniques such as plasmid design and construction, molecular cloning, protein expression, qPCR, cell culture, ELISA, plate-based luciferase and/or enzymatic activity assays, SDS-PAGE/western blotting, gene expression assays, etc.
Complexity and Problem Solving
- Hands-on experience in cell culture production processes. This includes small scale (shaker flasks, spinner flasks, spin tubes) and/or benchtop bioreactor scale. Familiarity with designing genetic control elements using a combination of molecular, cellular, and in vitro techniques.
- Strong analytical skills and problem-solving capabilities.
- 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.
- Working knowledge of state-of-the-art principles, technologies, and instrumentation.
- Effective communication skills (verbal, written, interpersonal). Must be able to draft protocols and technical reports.
- Must be able to interact with cross-functional teams.
- Analytical and problem-solving skills.
- Ability to manage time effectively.
- Ability to communicate and negotiate with vendors in a strategic manner.
- Ability to work well under pressure and meet deadlines.
- Proficiency in MS Office, JMP, Phyton and R/RStudio is a plus.
The Cell line Development and Molecular AAV Engineering Scientist is expected to use scientific principles and practices to solve a range of problems in creative and practical ways. The Cell line Development and Molecular AAV Engineering Scientist is expected to work with The Cell line Development and Molecular AAV Engineering Team in executing experiments, interpreting results, and performing any necessary troubleshooting.
Internal and External Contacts
Other Job Requirements
- Fellow Upstream PD Team Members.
- Cross-functional Team Members such as: PD Downstream, PD Analytical, Automation, PCO, Facilities, and Service Personnel/Vendors.
- External Vendors that offer equipment and/or services for various aspects of Process Development.
- 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. Also, several viral materials, including AAV, adenovirus and lentivirus may be involved in the work.
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.
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