This position is a key participant in the day-to-day operation and planning of rAAV vector production related work, with primary responsibility to execute tech transfer or established protocols of manufacturing research and pre-clinical grade rAAV vectors. The individual in the role will participate in (but not be limited to) manufacturing of rAAV vectors including gene therapy vector package cell lines maintenance, adherent and suspension cell culture, bioreactors, vector package, vector package cell lysis. Additionally, the individual will contribute to the implementation of documentation in order to support research and GLP rAAV vector manufacturing.
This position requires good knowledge and experience with cell culture, bioreactors, and good knowledge and skills related to manufacturing of bio-products in GLP/GMP environment. Good written and verbal communication skills and ability to work effectively in a team environment are required.
- Hands-on manufacture of AAV vectors, vector package cell maintenance, adherent and suspension cell culture, bioreactor operation, transfection for vector package
- Under instruction, manufactures research and GLP grade vectors using upstream processing
- Work together with Process Development, and Manufacturing Science & Technology team to transfer gene therapy vector production techniques from PD to PSO, and from PSO to MS&T
- Completes GLP documentation with limited to no errors i.e., batch records, logbooks, forms etc.
- Completes batch record utilizing good documentation practices
- Determines if results obtained comply with written procedures
- Maintains records
- Operates primary equipment independently within assigned area
- Generate, review and revise SOPs and batch records for vector production
- Perform routine calculations and maintain appropriate records using good documentation practices
- Maintain manufacturing equipment and records
- Maintain laboratory safety procedures and compliance records
- Analyzing and interpreting results; participating in discussions regarding the troubleshooting of PSO production processes and/or investigations; performing supporting studies as needed.
- Conducts data gathering and maintain database
- Develops supporting material for investigations i.e., Spreadsheets, copies of logs/batch records/attachments etc.
- Able to understand what the issue is and actively take corrective steps to fix the issue with instruction
- Prepare laboratory buffers, reagents and supplies for the manufacturing of research and pre-clinical grade rAAV vectors
- Participate in other projects upon request
Education and Experience Requirements
- A Bachelor's degree or Master’s degree in biology, biomedical, cell biology, or bioengineering
- More than 6 years of relevant work experience
- Experience with large scale vector or protein production
- Deep knowledge of cell culture (adherent & suspension)
- Strong experience in industry laboratory using GLP/ GMP
- Thorough knowledge of Microsoft Office suite
Key Skills, Abilities, and Competencies
- Delivering routine assignment with limited instructions; Delivering new assignment with detailed instruction
- Analyze problems and contribute to developing potential solution with the team
- Value research integrity and collaborative research
- Strong interpersonal, communication, analytical, and critical thinking skills, including being able to adapt to work areas requiring various intellectual and professional approaches
- Excellent organizational and time management skills
- Demonstrated leadership ability of providing direction/training to others, managing change of priority shift
Complexity and Problem Solving
- Discuss process variations and/or out of range results with supervisor and refer topolicies/practices for guidance.
- Exercise judgment within defined procedures and practices to determine appropriate action.
- Make recommendation of methods and procedures on new assignment.
- Must be comfortable in the fast-paced, biotech environment and interact with multi- disciplinary Research and Development, Process Development, Quality Assurance, Quality Control and Tech Operations teams.
Internal and External Contacts
- Fellow PSO Team Members
- Cross-functional Team Members such as: Process Development, Quality Assurance, R&D,MS&T, Translational Research, Quality Control, Analytical Sciences, Facilities, Materials Management
- Service Personnel/Vendors
Other Job Requirements
- Must be able to lift 25 pounds
- Must be flexible with work schedule
- Must be available to work extended shift hours as determined by management
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment
- Must be able to stand for long periods
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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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.
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