Manufacturing Specialist

This position is a key participant in the day-to-day operations of the vector production facility, with a primary responsibility to execute established procedures 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 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 for upstream virus production and downstream purification
• Prepare Manufacturing reagents/raw materials/column packing for the manufacture of commercial, clinical, and non-clinical vectors
• Participate in investigations
• Participate in aseptic fill operations of viral and excipient products
• Review and revise SOPs, Forms, and batch records for virus production and purification
• Perform calculations and maintain records
• Maintain manufacturing equipment
• Maintain laboratory safety procedures and compliance records

Responsibilities

% of Time

Job Function and Description

80%
• Hands-on cGMP manufacturing 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

15%
• 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
• Contributes to manufacturing process monitoring for products transferring from research to manufacturing
• Participates in efforts for troubleshooting and solving production process/equipment problems

5%
• Under the direction of Manufacturing Lead, participates in the coordination and implementation of special projects such as validation or complex investigations
• Advises Manufacturing Leads 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 2+ 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

Key Skills, Abilities, and Competencies

• Cell culture or protein purification experience
• Good written and verbal communications skills
• Must be adaptable
• Strict attention to detail
• Work effectively in a team environment
• Excellent organizational skills
• 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
Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent’s authority to make as well as those decisions that must be referred to a higher level.

• Able to make decisions whether results obtained through the manufacturing process comply with 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.

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.