This position is a key participant in the day-to-day operations and planning of the vector production facility, with a primary responsibility to execute established protocol of manufacturing commercial and clinical grade vectors in accordance with current Good Manufacturing Practices (cGMP). The position will participate in commercial and clinical grade Adeno-Associated Viral Vector (AAV) manufacturing, contribute to the implementation of documentation to support cGMP vector manufacture and participate in the production of cGMP gene transfer vectors to support clinical studies. • Hands-on cGMP manufacture in assisting upstream viral vector production and downstream purification • Prepare laboratory reagents/raw materials/column packing for the manufacture of commercial, clinical, and non-clinical vectors • Participate in quality record execution, such as deviation investigations, CAPAs, and change controls • Participate in aseptic fill operations of viral and excipient products • Review and revise SOPs and batch records for viral vector production and purification • Perform routine calculations and maintain appropriate records • Maintain manufacturing equipment and records • Maintain laboratory safety procedures and compliance records
• Hands-on manufacture cGMP manufacture including both upstream viral vector production and downstream purification • Prepares manufacturing support materials such as media and buffers • Prepares manufacturing equipment such as packing of chromatography columns of the manufacture of commercial and clinical vectors• Participates in investigations of process deviations by conducting data gathering, trending and data presentation as required • Writes and reviews manufacturing documents and procedures such as batch records and SOPs • Maintains manufacturing equipment and records • Maintain safety procedures and compliance records • Contributes to manufacturing process monitoring for products transferring from research to manufacturing • Determines verification of results obtained comply with written procedures • Participates in efforts for troubleshooting and solving production process/equipment problems• Ensures less experienced manufacturing specialists comply with SOPs and that training is completed • Under the direction of Manufacturing Lead, participates in the coordination and implementation of special projects such as validation or complex investigations • Advises Manufacturing Lead on improvements which may optimize work processes • Participates in internal meetings as appropriate
Education and Experience Requirements:
Bachelor's degree in biology, biomedical, chemistry, or engineering • Generally has 5+ years of relevant experience, or equivalent qualifications and experience • Experience with aseptic large scale cell culture or protein purification • Must have experience working in a cleanroom environment (ISO 8/7) • Demonstrated knowledge and understanding of cGMP regulations • Demonstrated training ability
Key Skills, Abilities, and Competencies:
Cell culture or protein purification for viral vectors a plus • Good written and verbal communications skills • Must be adaptable • Strict attention to detail • Work effectively in a team environment • Excellent organizational skills• Ability to act in a senior role for day to day operations in a small suite team • Ability for clear and open communication to team • Train, guide and develop less experienced employees • Requires thorough knowledge of Microsoft Office Suite
Complexity and Problem Solving:
Able to make decisions whether results obtained through the mftg process comply w/ the written procedures • Verifies process variations with more senior personnel • Consults with higher level personnel on unexpected or out of range results • Able to evaluate atypical events • High degree of initiative is required in resolving problems and developing recommendations • In collaboration with leadership, recommends methods and procedures for new assignments
Internal and External Contacts:
Continual interaction with members of his/her team as well as other manufacturing suite teams • Quality Control & Analytical Sciences • Quality Assurance • Facilities • Service personnel • Process Development • Materials Management
Other Job Requirements:
• Must be able to lift 25 pounds • Must be flexible with work schedule and 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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