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Scientist

1 month ago

Exton, United States Frontage Laboratories Full time
Scientist Biologics

Full Time

Exton PA or Spring House PA

Frontage Laboratories

Frontage Laboratories is a CRO/Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets. Come and join us to make a world of difference.

Biologics

Frontage's biologics teams have an average of 10 - 15 years in complex drug development and have worked with large molecule applications throughout its evolution in product development. We can handle projects for a range of large molecule development projects including peptides, proteins, monoclonal antibodies, bispecific antibodies, biosimilars, oligonucleotides, biomarkers, and antibody drug conjugates.

Gain access to comprehensive biologics services in support of advanced development programs with Frontage's bioanalytical laboratory. We have the capabilities to analyze virtually any peptide, protein, or antibody, and have built a reputation for solving technical challenges related to assay development and validation.

Position Summary

This is a technical bench scientific position within the Biologics Service Team. The Biologics Service Team is responsible for conducting bioanalytical methods Pharmacokinetics (PK), Anti-drug Antibody (ADA) and/or Neutralizing Antibody (NAb) related to large molecule biotherapeutic drug development across all therapeutic areas, spanning nonclinical studies to post-market clinical development. The scientist will assist with the interpretation of data resulting from analyses of bioanalytical samples, and work with senior staff to assess, troubleshoot, develop, and validate new assays. They may also perform other duties, as assigned, to meet business needs.

Responsibilities
  1. Responsible for qualification and preparation of controls and reagents to support PK, ADA or NAb assay methods to quantify concentrations of therapeutic proteins.
  2. Required to assist with assay validations, routine lab operations.
  3. Responsible for maintaining an electronic lab notebook, participation in GLP compliance activities and other duties as needed.
  4. Performs job duties with some supervision. Collaborates effectively with fellow team members following priorities, checkpoints, and timelines in support of objectives set by direct supervisors.
  5. Communicates with internal and external team members regarding assigned tasks through written and oral communication.


Requirements
  1. BS or MS in biochemistry, biomarker, molecular biology, or a related field.
  2. Experience in immunoassay development and validation in a GLP lab (21CFR part 11 compliant) is preferred.
  3. Experience with Meso Scale Discovery (MSD) immunoassays or ELISA.
  4. Experience in a biopharma company, Clinical Research Organization (CRO) or diagnostic lab environment is preferred.


Significant Safety or Working Considerations:
  • May work with potentially infectious samples of human and/or animal origin.
  • May handle hazardous chemicals.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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