Senior Manufacturing Technician

Organization
Spark Therapeutics
Job Location
Philadelphia, PA
Job Description

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 pre-clinical 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. The position requires good knowledge and experience with cell culture and recombinant viral vectors production and purification methods and an understanding of practices and procedures required to achieve large scale clinical vector manufacturing, ensuring product quality, safety and consistency as required by cGMP. This position is expected to combine strong scientific and technological knowledge, skills relating to producing and purifying viral vectors with implementation, and compliance of current good manufacturing practices for human biological products. The position requires excellent written and verbal communication skills and an ability to work effectively in a team environment. 

RESPONSIBILITIES: 

Hands-on cGMP manufacture of AAV vectors manufacture in assisting upstream virus production and downstream purification of AAV 
Prepare laboratory reagents/raw materials/column packing for the manufacture of clinical and non-clinical AAV 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

Requirements: 

REQUIREMENTS: 

Bachelor's degree in biology, biomedical, or engineering 
2-5 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) 
Must have experience in a regulated clinical or industry laboratory using GLP/ GMP 
Must be able to lift 25 poundsuf

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.

Gladys Kong writes at Fortune that her STEM background has helped her as a CEO.

Social scientists report that the image of the 'lone scientist' might be deterring US students from STEM careers.