Specialist/Senior Specialist, Quality Assurance

Protagonist Therapeutics; Newark (CA); In loco; USD 130.000 - 160.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

401(k) Plan

Flexible vacation

Life Insurance

Descrizione del lavoro

Protagonist Therapeutics is seeking a Specialist/Sr. Specialist, Quality Assurance to perform GMP QA activities supporting manufacturing. The role reports to the Head of QA and prioritizes QA GMP support with a risk-based approach, including batch record and deviation reviews.

We are committed to an in-office culture with on-site work in Newark, CA four days per week. The position requires 5+ to 8+ years in biotech/pharma QA and willingness to travel up to 25% (incl. international).

Competenze

• Bachelor’s Degree in a scientific or related discipline; advanced degrees are a plus.
• 5+ years in biotech/pharmaceutical QA with GMP experience; ASQ is a plus.
• Experience interpreting EU, FDA and ICH regulations and guidance documents.

Mansioni

• Develop quality oversight strategy for CMOs and QA GMP vendor audits.
• Support regulatory inspections and internal audits; review batch records.
• Review analytical methods, specifications, validation protocols and reports.
• Manage CAPAs and change controls; close CC packages.
• Investigate product complaints, recalls and stock recovery as needed.
• Travel up to 25%, including international travel; work with cross-functional teams.

Conoscenze

Excellent communication

Cross-functional collaboration

Quality focus

Attention to detail

Self-motivated

Organizational skills

Formazione

Bachelor’s degree in a scientific discipline

Advanced degree a plus

Descrizione del lavoro

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.

Position Summary

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 elevate compliance issues to enable pro-active decision-making supporting GMP activities.

We are committed to a thriving in-office culture

This role requires being on-site at our office in Newark, CA 4 days a week.

Responsibilities

• Responsible as subject matter expert to develop quality oversight strategy for selected contract manufacturing organizations (CMOs).
• Support regulatory inspections and internal audits.
• Review of Master Production Batch Records and Executed Batch Records (including analytical results and supporting data packages).
• Responsible for completing batch record review checklist, when applicable.
• Review and approval of analytical methods, product specifications, analytical method validation protocols, and reports.
• Review and approval of stability protocols, data tables and stability reports.
• Review and approval of deviation, OOS, and OOT investigations.
• Manage and review CAPAs (corrective action / preventive action) activities and process.
• Manage and review Change Controls (CC) and CC packages for closure.
• Review and approval of process validation protocols and reports.
• Investigate, manage, and approve product complaints reports for closure.
• Assist with product recall / stock recovery investigations and reports, as necessary.
• Working experience of Quality Systems and other key systems that support a company's quality management system.
• Perform QA GMP vendor audits and write audit reports with findings, when necessary.
• Must be capable and willing to travel (up to 25%), including international travel.
• Work collaboratively with cross-functional project teams.
• Keep current on changes in applicable FDA and European regulations, directives, and guidelines and advise on potential impact to GMP activities.
• Maintain flexibility to perform other additional tasks as assigned.

Required Skills & Qualifications

• Bachelor’s Degree in a scientific or related discipline with advanced degrees a plus.
• Typically requires a minimum of 5+ / 8+ years in biotech/pharmaceutical industry, with Quality Assurance experience.
• ASQ certification a plus.
• Demonstrated expertise and ability to interpret and apply EU, FDA and ICH regulations and guidance documents.
• Self-motivated and comfortable with minimal direction.
• Proficient in organization, prioritization, time management, and able to manage multiple priorities.
• Proficient computer skills and experience with commonly used productivity software.
• Excellent oral and written communication skills.
• Demonstrated ability to work effectively in cross-functional teams.
• Strong focus on quality and attention to detail.

Pay Range

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.

Benefits

• Health Care benefits. Protagonist covers 100% of the premium cost for medical, dental, and vision coverage for all full-time employees and their dependents.
• Flexible Spending Accounts – Healthcare FSA, Dependent Care FSA, Commuter Benefits
• 401(k) Plan
• Flexible Vacation Policy
• Life Insurance (Basic, Voluntary & AD&D)
• Short Term & Long Term Disability
• Company paid lunch and snacks