Senior Scientist Analytical Development & Quality Control
About The Position
Protagonist Therapeutics is seeking a talented and highly motivated Senior Scientist to join the Analytical Development & Quality Control (ADQC) group. The successful candidate will help drive analytical development strategy for small-molecule and peptide candidates from early development through late-stage programs, including analytical method development, validation, transfer, stability programs, phase-appropriate specifications, and analytical control strategies for drug substance (DS) and drug product (DP). This role includes leading internal analytical activities, managing external CDMO partners, and collaborating closely with Drug Substance, Drug Product, Supply Chain, Quality Assurance, Regulatory, Nonclinical, and Clinical teams to achieve program objectives.
Requirements
- PhD or MS in Analytical Chemistry or a relevant scientific discipline, with 5+ years of experience supporting early- and late-stage CMC development.
- Hands-on expertise in UHPLC method development using a range of detection technologies, including UV, PDA, MALS, CAD, conductivity, fluorescence, and advanced MS for identification and structural characterization.
- Extensive experience communicating with and managing analytical development and QC functions at CDMOs.
- Strong knowledge of cGMP/GLP compliance, pharmaceutical quality systems, and regulatory requirements for drug development.
- Excellent written and verbal communication skills, with the ability to effectively represent analytical development plans to CDMOs, internal project teams, CMC teams, and senior management.
- Ability to manage priorities and maintain timelines in a fast-paced environment while balancing speed, quality, and risk.
- Strong project management, communication, leadership, and cross-functional collaboration skills.
Nice To Haves
- Extensive experience developing analytical methods for synthetic peptides or similarly complex drug substance molecules, such as ADCs, PEGylated proteins, or monoclonal antibodies, is highly preferred.
- Demonstrated ability to solve complex scientific and business challenges.
- Experience in small- to mid-size innovator companies is desired.
- Ability to travel domestically and internationally, as needed.
Responsibilities
- Develop, optimize, and validate analytical methods for release, stability, and characterization testing of DS and DP.
- Lead impurity identification, degradant analysis, comparability assessments, method transfer, and analytical method lifecycle management.
- Establish phase-appropriate, scientifically robust analytical control strategies, including characterization plans and specification setting, to support clinical and regulatory requirements and enable accelerated development timelines.
- Troubleshoot analytical issues and support investigations, including OOS/OOT results, deviations, root-cause analysis, CAPA recommendations, and change-control activities, as applicable.
- Manage stability and reference standard programs for assigned projects.
- Communicate effectively with stakeholders and manage analytical development and QC testing activities at CDMOs.
- Review CDMO data for release testing, stability testing, and DS/DP characterization to ensure scientific rigor, data integrity, and compliance.
- Author analytical sections for regulatory filings, including INDs, IMPDs, and NDAs, and provide input to relevant Module 3 sections.
- Participate in continuous improvement initiatives, including process and workflow improvements, CDMO management practices, and SOP development or revision in collaboration with Quality Assurance.
- Represent ADQC in cross-functional team meetings.
Benefits
- The base pay range for this position at commencement of employment is expected to be between $140K and $160K / year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
