Upstream GMP Scientist I

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

As an Upstream GMP Scientist I you will have a strong background in cell culture and bioreactor operations at pilot and GMP scale, preferably in rAAV production. You will receive processes transferred into GMP, and author batch records, SOPs as well as deviation investigations. You will execute GMP processes in appropriate grade clean rooms trained in gowning and all relevant GMP processes and procedures. Personnel in this position will mentor and train associates as well. Unlike traditional manufacturing personnel, our model aims to train GMP personnel to be process science experts as well and there will be times when they will work closely with PD/MS&T to perform development work as well. The Upstream GMP Scientist I will have mastered the skills and responsibilities of a GMP Associate Scientist and will be mastering the skills and responsibilities of a GMP Scientist.


Qualifications

  • B.S. in Biology, Biochemistry, Engineering or related field preferred but not required with 3–5 years' experience.
  • Understanding of relevant science and proficiency in laboratory/GMP space techniques. Strong attention to detail and ability to document activities and follow protocols. Preparation of buffers and solutions. Comfort with routine calculations, tracking and interpreting data. Proficient with Microsoft Office, lab and equipment software. Familiarity with statistical analysis software preferred. Ability to follow GMP and execute in GMP environment when needed.
  • Mastered GMP execution of all relevant areas. Understands regulations applicable to area and how to conduct deviation investigations. Understanding of GMP materials controls, facilities, and equipment.
  • Strong problem-solving skills, planning and mitigation of risks. Strong understanding of data measurements and variability. Ability to troubleshoot and involve/communicate with management and QA as required. Involved in technology transfer.
  • Strong communication, ability to present and write technical instructions and deviation reports. Ability to train and assist Associate level scientists. Analyze data and interpret results to identify trends and work with development scientists to make improvements. Assist in preparing documents for regulatory submissions.
  • Strong understanding of cell culture and bioreactor operations. Strong understanding of in-process monitoring equipment, probes and assays. Understanding of analytics testing results, including AAV quality and purity. Proficiency in AAV production, and an understanding of stability and impact of process variable on AAV yield and quality.



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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