Scientist, Assay Development (Non-PhD)

Employer
Pfizer
Location
Andover, Massachusetts
Posted
Sep 11, 2020
Ref
4789891
Required Education
Bachelors Degree
Position Type
Full time

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 (plasma, serum) to measure compound concentration, detect the presence of anti-drug antibody and neutralizing anti-product antibody activity utilizing various platforma 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

 

Other Job Details:

  • Last Date to Apply for Job: September 30th 2020
  • Eligible for Employee Referral Bonus