Method Development Scientist - Large Molecule

LabcorpChantilly, VA
392dOnsite

About The Position

The Method Development Scientist - Large Molecule is a laboratory-based role focused on researching and developing advanced bioanalytical methods for evaluating pharmacokinetics, pharmacodynamics, and immunogenicity of novel biopharmaceutical compounds. This position requires a strong understanding of ELISA-based immunochemistry principles and involves collaboration with pharmaceutical and biotechnology companies to deliver impactful medicines. The scientist will lead complex bioanalytical projects, generate critical scientific results, and communicate effectively with clients and stakeholders.

Requirements

  • MS or PhD in chemistry or equivalent degree with 2-5 years of industry-related experience.
  • Experience with various ELISA-based platforms (e.g., ELISA, Meso-Scale Discovery).
  • Proven track record of method development and troubleshooting using de-novo approaches or transfer of qualified/validated plate-based immunoassays.
  • Skilled in conducting research, compiling data, interpreting data, and writing reports according to FDA & EMA Bioanalytical Method Validation & Immunogenicity regulatory requirements.
  • Effective oral and written communication skills.

Nice To Haves

  • Experience with Cell-Based Assays is a plus, but not required.
  • Knowledge of laboratory automation software and system software.

Responsibilities

  • Develop and transfer highly sensitive and reliable immunoassay methodologies for analyzing pharmaceuticals in biological fluids and tissues.
  • Perform complex analytical methods on biological matrices, addressing problem-solving situations as they arise.
  • Develop or qualify immunoassay methods in a phase-appropriate manner to support pre-clinical or clinical studies.
  • Apply and interpret scientific theories, concepts, techniques, and regulatory requirements in bioanalysis of large molecule therapeutics.
  • Act as lead research scientist for technical direction on complex bioanalytical projects in a team setting.
  • Respond to unscheduled deadlines and client needs while managing other duties.
  • Produce method development reports for reliable and sensitive methods of analysis.
  • Author scientific papers or posters for publication in peer-reviewed journals or presentation at conferences.
  • Participate in client visits and contribute to long-range planning and technical policies of the department.
  • Perform other related duties as assigned.

Benefits

  • Medical
  • Dental
  • Vision
  • Life Insurance
  • Short-Term Disability/Long-Term Disability (STD/LTD)
  • 401(k)
  • Paid Time Off (PTO) or Flexible Time Off (FTO)
  • Tuition Reimbursement
  • Employee Stock Purchase Plan

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Industry

Ambulatory Health Care Services

Education Level

Master's degree

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