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Sr. Manufacturing Specialist

Date: Apr 1, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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.

 

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 Viral vector 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 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 viral vector production and purification
  • Perform routine calculations and maintain appropriate records
  • Maintain manufacturing equipment and records
  • Maintain laboratory safety procedures and compliance records

 

Responsibilities

80%     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 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

 

Competencies

 

  • Cell culture or protein purification 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


Nearest Major Market: Philadelphia