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Process Development Scientist

Philadelphia Metro Area, PA

Post Date: 10/30/2017 Job ID: JN -102017-20341 Job Type: Scientific

Process Development Scientist
Scale-up of Antibody Drug Conjugate production processes for cGMP Manufacturing.


  • Perform and execute scale-up activities for GMP bioconjugation processes, including familiarization, optimization and trial runs.
  • Fluorescent-Probe Bioconjugation and Protein-Protein cross-linking
  • Prioritize work assignments, consistently follow SOPs, Batch Records, ICH and FDA guidelines
  • Be responsible for the planning, development and optimization of synthetic routes/strategies, the execution and delivery of bioorganic reactions.
  • Perform laboratory scale experiments in support of GMP bioconjugation projects
  • Coordinate activities with QA, QC, Management, and other cross-disciplinary teams
  • Maintain clear and detailed records of their work in lab notebooks and batch records
  • Author SOPs, batch records and other relevant documents as necessary
  • Maintain a safe, pleasant and efficient working environment
  • Work with GMP Analytical for outline analytical methods needed to support GMP bioconjugation processes.
  • Act as the representative between R&D and the Quality Group for authoring and approving batch records for GMP bioconjugation processes.
  • Education / Experience:

  • B.S. or higher degree in biochemistry, biochemical engineering or related disciplines
  • 3-5 years of GMP operations experience
  • Experience in scale-up, Process Development and technology transfer of biologics downstream processes, including ultrafiltration/diafiltration and column chromatography methods
  • Demonstrated expertise in bioconjugation related to theory and practice of bioorganic and protein chemistry;
  • Excellent problem solving skills and demonstration of a thorough understanding of protein chemistry, protein handling, purification and characterization;
  • Expertise in the purification and characterization of proteins and protein conjugates using applicable modern techniques. Candidate must be comfortable with routine use of HPLC, LC/MS, FPLC (affinity purification, size exclusion chromatography, hydrophobic interaction chromatography, etc.), SDS-PAGE and UV-VIS spectroscopy;

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