Manufacturing Specialist
- Employer
- Spark Therapeutics
- Location
- Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
- Salary
- Salary not provided
- Closing date
- May 14, 2022
View more
- Discipline
- Other, Manufacturing/QA/QC
- Organization Type
- All Industry, Pharma
Job Details
- 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
% 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 columns15%
• 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 problems5%
• 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
- 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
- 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
- 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
- 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.
Company
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
- Website
- http://sparktx.com/
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