Scientist - Immunogenicity - Exton, United States - Frontage Laboratories

Description

Scientist - Immunogenicity

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 group is responsible for developing, validating, and conducting bioanalytical methods related to large molecule biotherapeutic drug development across all therapeutic areas, spanning non-clinical studies to post-market clinical development.

The scientist will perform assigned projects and work closely with peers in Biologics group to perform routine Anti-drug Antibody (ADA) and Neutralizing Antibody (NAb) immunoassay bioanalysis in the support of clinical and non-clinical studies. He/She 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. He/She may also perform other duties, as assigned, to meet business needs.

Responsibilities

1. Accurately perform immunoassays (ADA/NAb) following well defined guidelines as per their respective SOPs and checklists in a GLP laboratory. Perform assigned tasks with decreasing level of supervisor's assistance over time.
2. Run bioanalysis independently based on supervisor's directive.
3. Independently set up bioanalytical runs.
4. Independently perform assay steps and track samples/reagents appropriately in Watson Laboratory Information Management System (LIMS) or Mosaic reagent management system.

2. Clearly and precisely report data and observations from analysis utilizing the various laboratory data computer systems (Watson LIMS/Biovia ELN/Titian eLIMS).

1. Import and evaluate (regress) analytical run data.
2. Select results and assess plate acceptance (pass/fail).
3. Identify samples for subsequent/repeat analysis, technical errors, and the need for deviation memos.

3. Maintain current laboratory equipment and operate analytical and other instruments.

4. Maintain accurate record keeping and experimental data with the use of statistical packages and standard databases. An emphasis on Good Laboratory Practice (GLP) compliance for all work and documentation is required.

5. Good written and oral communication skills. Communicate results and/or any problems that may arise to supervisor in a timely manner.

6. Required to assist with assay validations, routine lab operations.

7. Responsible for participating in GLP compliance activities and other duties as needed.

Requirements

1. M.S. with 3-5 years of experience or a B.S./B.A. with 4-8 years of experience, or the equivalent training/experience.
2. Experience performing immunoassay testing in a GLP laboratory.
3. Experience with the Watson Laboratory Information System and/or an electronic notebook is a plus.

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.