Frederick Maryland United States
Job Type: regular full-time
Division: Precision for Medicine
Business Unit: Translational Sciences
Requisition Number: 4788
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, Bioanalytical?
Position Summary
The Bioanalytical Scientist manages staff to accurately and efficiently perform assays to support ongoing services and contract activities. This role will perform assays according to SOPs and support development of new procedures and improvement of existing SOPs.
Essential functions of the job include but are not limited to
- Design and perform experiments, independently and accurately analyze and present data
- Responsible for high quality output with the ability to build efficiency into improving productivity metrics
- 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
- Assist in establishing and improving all procedures and required SOP documentation
- Responsible for troubleshooting and correcting routine scientific issues/problems
- Identify, update and implement emerging laboratory techniques
- Maintain and support safe lab practices and environment
- Work collaboratively with other technical teams in resource sharing and providing technical expertise
- Support new equipment operational qualifications and performance checks
- Monitor Product and Service/R&D related project expenses
- Act as a scientific resource externally to clients and internally
- Assists with writing, reviewing and editing contract and grant applications/proposals as appropriate
- Assist with writing and reviewing project reports and editing contract proposals
- Assists with writing and publishing papers, abstracts, techniques/or chapters to maintain the scientific standard and image of the company
- May present completed work at appropriate scientific meetings and in publications
- Carry out other duties/projects as assigned
Qualifications
- Master's Degree in life sciences or Bachelors in life science with 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/cell/gene-based therapeutics
- Experience in different ligand binding technology platforms, such as ELISA, MSD, Quanterix, Luminex, Biacore/SPR
- Strong background in leading bioanalytical and biomarker assay qualification and validation
- Demonstrate an ability to work 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:
- D. in life sciences, with a minimum of 2 years post-doctoral training, industry experience or equivalent combination of education and experience preferred
- Previous work experience in GLP or GCLP environment and a solid understanding of current GXP standards
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