Scientist, Assay Development (Non-PhD)

ROLE SUMMARY

• Work under the guidance of a supervisor with high degree of independence.
• Responsible for the development of robust and reliable ligand binding assay suitable for the quantitation of biotherapeutics in various biological matrices.
• Responsible for the development robust and reliable ligand binding assay and /or cell-based assays suitable for characterizing the disposition and immunogenicity of biotherapeutics in various biological matrices using a range of potential screening platforms and assay techniques.
• High degree of independence in the design, trouble shooting, validation and conduct of the assay to support biotherapeutic programs.
• Timely delivery of concentration and immunogenicity data to a supervisor and other partners in compliance with local or global regulatory requirement.
• Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support.
• Development and validation of assays to be governed per departmental SOPs.
• Accurate execution and documentation of bioanalytical method in a regulatory compliant manner.
• Ensure GLP and GCP compliance is maintained in laboratory during study support

ROLE RESPONSIBILITIES

• Laboratory focused position. Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms.
• Design, develop and implement ligand binding assays using different platforms (e.g. ELISA, ECL, Gyros detection) in biological matrix (e.g., plasma, serum) to measure compound concentration, detect the presence of anti-drug antibody and neutralizing anti-product antibody activity utilizing various platform in a regulated (GLP, GCP) environment against challenging time lines.
• When needed, participate in the design, development and implementation of cell-based assays.
• Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
• Analytical problem solving
• Gathers input from colleagues, literature, and additional resources to assist in driving the project forward.

BASIC QUALIFICATIONS

• BSc with at least 6+ years relevant GLP/GCP laboratory experience, specifically with a focus on ligand binding assay development experience in a biological matrix (plasma, serum), or a MSc with at least 4+ years of experience.
• Experience supporting large molecules.
• Industry experience and/or bioanalytical experience in a regulated environment is mandatory.
• Skills in GLP/GCLP/GMP compliant analysis including following SOP and provision of quality regulatory documents.
  

PREFERRED QUALIFICATIONS

• Cell-based assay experience is preferred
  

PHYSICAL/MENTAL REQUIREMENTS

This is laboratory based position, the activities involves Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis

#LI-PFE

Other Job Details:

• Additional Location Information: Andover, MA
• Eligible for Employee Referral Bonus

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EEO & Employment Eligibility

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Research and Development