Manufacturing Associate II

2 months ago

King of Prussia, United States Franklin Biolabs Full time

Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson's laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry.


As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive suite of services spanning from discovery through clinical manufacturing. Our goal is to empower our partners by providing unparalleled solutions that drive the advancement of genetic medicines. Leveraging decades of expertise and a commitment to excellence, we bridge the gap between groundbreaking research and ensuring that transformative therapies reach those who need them most.


Job Summary

The primary role of the Downstream GMP Associate Scientist is to support GMP manufacturing purification of AAV gene therapy products for Franklin Biolabs. The Associate Scientist functions will include training on standard operating procedures (SOPs), performance qualifications for associated skills and execution of batch records in compliance with current Good Manufacturing Practices (cGMP). The Associate Scientist will operate and acquire proficiency with equipment associated with tangential flow filtration (TFF), chromatography (Affinity, IEX) and filtration techniques integral to the manufacturing process. The associate will be responsible for the request, receipt and staging of materials used in the manufacturing process and support setup up of the manufacturing area.


Qualifications

  • B.S. if Biology, Biochemistry or related field preferred but not required. With 1 – 3 years' experience
  • Understanding of science and and aseptic techniques. Strong attention to detail and ability to document activities and follow protocols
  • Comfort with routine calculations, tracking and interpreting data. Proficient with Microsoft Office, lab and equipment software. Ability to follow GMP and execute in GMP environment when needed
  • Flexible working hours and the willingness to work outside normal business on occasion when required by process
  • Understanding of the science behind activities performed. Execution including operation and basic maintenance of scientific equipment. Perform routine GMP suite/laboratory tasks. Emphasis on Good Documentation Practices
  • Ensure compliance when using regulated equipment and with GMP suite/ laboratory safety.
  • Understanding of measurement outputs and scientific accuracy will be taught and built as the position progresses
  • Good documentation practices (with particular emphasis on ALCOA), good verbal and written communication. Ability and willingness to follow direction and ask questions, raise risks. Good contribution to planning and good teamwork
  • Meet deadlines for GMP documents and training (investigations, document close out etc.) Understand that work impacts safety and efficacy of drugs manufactured and tested for human use.
  • Begin to get familiar with regulatory expectations for therapeutic drug development. Scientific, documentation, and data integrity is critical



Application note

Franklin Biolabs is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Franklin Biolabs via email, the Internet, or directly without a valid written search agreement for this role will be deemed the sole property of Franklin Biolabs and no fee will be paid in the event the candidate is hired.

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