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Lead Manufacturing Specialist

Date: Apr 7, 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 manufacturing operations and planning of the vector production facility.  Reporting to the Manufacturing Lead, the primary responsibility of the Lead Manufacturing Specialist is to manufacture cGMP grade vectors. 

S/he will participate in Vector manufacturing including support for clinical and commercial manufacturing, new product scale up, process optimization, technical transfer from process development to manufacturing and process validation. 

 

Responsibilities

65%       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

 

20%       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 for virus production and purification

 

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

 

Leads efforts for troubleshooting and solving production process/equipment problems

 

15%       Organizes and manages detailed production schedules to ensure required tasks are performed

 

Ensures less experienced manufacturing specialists comply with SOPs and that training is completed

 

Under the direction of Manufacturing Lead, leads 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 required
  • 7-10+ years of relevant experience in biopharmaceutical manufacturing facility subject to GMP regulations
  • Experience with cell culture or protein purification a plus
  • Demonstrated deep applied knowledge and understanding/awareness of cGMP regulations
  • Strong knowledge of either upstream and/or downstream unit operation
  • Demonstrated team leadership ability

 


Nearest Major Market: Philadelphia