Sr Manufacturing Specialist

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 clinical grade vectors in accordance with current Good Manufacturing Practices (cGMP). The position will participate in clinical grade Adeno-Associated Virus 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 virus production and downstream purification
• Prepare laboratory reagents/raw materials/column packing for the manufacture of clinical and non-clinical vectors
• Participate in investigations
• Participate in aseptic fill operations of viral and excipient products
• Review and revise SOPs and batch records for virus production and purification
• Perform routine calculations and maintain appropriate records
• Maintain manufacturing equipment and records
• Maintain laboratory safety procedures and compliance records

Responsibilities

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

% of Time

Job Function and Description

80%

• Hands-on manufacture cGMP manufacture including both upstream virus 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 clinical and commercial vectors

10%

• 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

10%

• 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

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

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.