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Bioanalytical Scientist

3 months ago


Frederick, United States Precision For Medicine Full time

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Scientist?


Overview:

The Bioanalytical Scientist manages staff to accurately and efficiently perform assays to support ongoing services and contract activities.


Essential functions of the job include but are not limited to:

  • Support development of projects in a timely manner in strict accordance with documented procedures
  • Perform assays according to defined protocol/SOP and support development of new procedures
  • Supervise assigned laboratory staff to ensure efficient organization, development and execution of project(s)
  • Design and perform experiments, independently and accurately analyze and present data
  • Responsible for troubleshooting and correcting routine scientific issues/problems
  • Assist with writing and reviewing project reports and editing contract proposals
  • Carry out other duties/projects as assigned


Qualifications:


Minimum Required:

  • Master’s Degree in life sciences or related field
  • 5 years of relevant laboratory experience


Other Required:

  • Must have demonstrated expertise developing, troubleshooting, and performing bioanalytical assays in plate-based and cell-based assay formats, including pharmacokinetic (PK), biomarker, anti-drug antibody (ADA), neutralizing antibody (NAb) assays for protein and AAV-based therapeutics
  • Experience in different bioanalytical technology platforms, such as ELISA, MSD, Luminex, Biacore/SPR
  • Strong background in leading bioanalytical assay validation
  • Demonstrate an ability to working independently in planning, executing and analyzing data.
  • Solid understanding of current regulatory standards of bioanalytical assays
  • Experience in good documentation practices (GDP)
  • Proven experience managing, leading teams
  • Excellent communication, interpersonal, organizational and multi-tasking required
  • Must have the ability to independently organize and analyze data and prepare reports
  • Must possess strong computer skills, including experience with Prism, Microsoft Word, and Excel
  • Ability to lift and carry between 1-15 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC)
  • Must be able to read, write, speak fluently and comprehend the English language


Preferred:

  • Ph.D. in life sciences, with a minimum of 2 years post-doctoral training, industry experience preferred
  • Previous work experience in GLP environment and a solid understanding of current GLP standards