Specialist/Senior Specialist, Quality Assurance

 

Protagonist Therapeutics is a discovery-through-late-stage development biopharmaceutical company with a proprietary technology platform that enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE was launched in the U.S. in March 2026, is approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. Protagonist also discovered and led development through Phase 3 of rusfertide, a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceuticals. An NDA for rusfertide for the treatment of polycythemia vera is under priority review with the FDA. The Company also has a number of clinical and preclinical programs addressing clinically and commercially validated targets, including an oral IL-17 antagonist peptide, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.

More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.

 

This Specialist / Sr. Specialist, Quality Assurance role will be responsible for performing Quality Assurance activities in support of GMP manufacturing. These responsibilities will include supporting GMP manufacturing oversight, batch record review, deviation review, etc. This individual will provide QA expertise and guidance regarding GMP guidelines to ensure GMP Manufacturing compliance. 

This position will report to the Head of QA and be an integral part of the QA team.  In this role, the individual will utilize a risk-based strategy to prioritize QA GMP support activities (review of executed batch records, deviations, analytical data, stability data, and other GMP documents and reports), identify, and escalate compliance issues to enable pro-active decision-making supporting GMP activities.

 

The successful candidate should be able to perform the following QA responsibilities and activities. This includes but is not limited to:

The base pay range for this position at commencement of employment is expected to be between $130,000 and $160,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

 

A top priority for Protagonist Therapeutics, Inc. is to provide a robust and comprehensive health and wellness program for our employees and their families. We offer a variety of high-quality coverage and benefit options.