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Sr. Scientist, Pre-Clinical Manufacturing

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Oct 18, 2022

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Job Details

This position is a key participant in the day-to-day operation and planning of rAAV vector production related work, with primary responsibility to execute tech transfer or established protocols of manufacturing research and pre-clinical grade rAAV vectors. The individual in the role will participate in (but not be limited to) manufacturing of rAAV vectors including gene therapy vector package cell lines maintenance, adherent and suspension cell culture, bioreactors, vector package, vector package cell lysis. Additionally, the individual will contribute to the implementation of documentation in order to support research and GLP rAAV vector manufacturing.

This position requires good knowledge and experience with cell culture, bioreactors, and good knowledge and skills related to manufacturing of bio-products in GLP/GMP environment. Good written and verbal communication skills and ability to work effectively in a team environment are required.

Responsibilities

  • Hands-on manufacture of AAV vectors, vector package cell maintenance, adherent and suspension cell culture, bioreactor operation, transfection for vector package
  • Under instruction, manufactures research and GLP grade vectors using upstream processing
  • Work together with Process Development, and Manufacturing Science & Technology team to transfer gene therapy vector production techniques from PD to PSO, and from PSO to MS&T
  • Completes GLP documentation with limited to no errors i.e., batch records, logbooks, forms etc.
  • Completes batch record utilizing good documentation practices
  • Determines if results obtained comply with written procedures
  • Maintains records
  • Operates primary equipment independently within assigned area
  • Generate, review and revise SOPs and batch records for vector production
  • Perform routine calculations and maintain appropriate records using good documentation practices
  • Maintain manufacturing equipment and records
  • Maintain laboratory safety procedures and compliance records
  • Analyzing and interpreting results; participating in discussions regarding the troubleshooting of PSO production processes and/or investigations; performing supporting studies as needed.
  • Conducts data gathering and maintain database
  • Develops supporting material for investigations i.e., Spreadsheets, copies of logs/batch records/attachments etc.
  • Able to understand what the issue is and actively take corrective steps to fix the issue with instruction
  • Prepare laboratory buffers, reagents and supplies for the manufacturing of research and pre-clinical grade rAAV vectors
  • Participate in other projects upon request

Education and Experience Requirements

  • A Bachelor's degree or Master’s degree in biology, biomedical, cell biology, or bioengineering
  • More than 6 years of relevant work experience
  • Experience with large scale vector or protein production
  • Deep knowledge of cell culture (adherent & suspension)
  • Strong experience in industry laboratory using GLP/ GMP
  • Thorough knowledge of Microsoft Office suite

Key Skills, Abilities, and Competencies

  • Delivering routine assignment with limited instructions; Delivering new assignment with detailed instruction
  • Analyze problems and contribute to developing potential solution with the team
  • Value research integrity and collaborative research
  • Strong interpersonal, communication, analytical, and critical thinking skills, including being able to adapt to work areas requiring various intellectual and professional approaches
  • Excellent organizational and time management skills
  • Demonstrated leadership ability of providing direction/training to others, managing change of priority shift

Complexity and Problem Solving

  • Discuss process variations and/or out of range results with supervisor and refer topolicies/practices for guidance.
  • Exercise judgment within defined procedures and practices to determine appropriate action.
  • Make recommendation of methods and procedures on new assignment.
  • Must be comfortable in the fast-paced, biotech environment and interact with multi- disciplinary Research and Development, Process Development, Quality Assurance, Quality Control and Tech Operations teams.

Internal and External Contacts

  • Fellow PSO Team Members
  • Cross-functional Team Members such as: Process Development, Quality Assurance, R&D,MS&T, Translational Research, Quality Control, Analytical Sciences, Facilities, Materials Management
  • Service Personnel/Vendors

Other Job Requirements

  • Must be able to lift 25 pounds
  • Must be flexible with work schedule
  • Must be 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.

Learn more about Spark Therapeutics and view other openings.

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.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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