JOB DESCRIPTION

Protagonist Therapeutics located in Newark, CA is seeking an individual to provide scientific, technical and hands-on leadership in support of oral drug product development. The ideal candidate will

• Be responsible for oral peptide formulation development from discovery candidate nomination through clinical development, as leader and mentor to formulation senior scientists
• Provide technical input and oversight for outsourced formulation development CDMO and/or formulation testing laboratories
• Be responsible for preformulation and research formulation activities, ensuring scalability and successful technical transfer to CDMO for clinical supplies manufacturing
• Be responsible for CDMO management for clinical supplies and global CMC regulatory submissions (INDs, IMPDs, NDAs)

REQUIRED SKILLS

• Expertise in formulation and process development for oral delivery:
• comprehensive knowledge of excipients and their function (both conventional and novel)
• comprehensive knowledge of oral dosage forms (tablets, capsules, softgels, solution, suspensions) and their process development (tableting, capsule filling, capsule sealing, milling, granulation (wet/dry), extrusion, homogenization, coating, drying, spray drying, emulsification, lyophilization)
• Comprehensive knowledge of formulation techniques (e.g. lipid-based formulations, microemulsions/SEDDS, nanocrystal/nanoparticles, particulate or solid dispersion formulations, complexation, supersaturation, immediate/delayed/modified release, co-release, stability-enhancement, solubility-enhancement)
• Expertise in cGMP principles and CDMO oversight for GMP manufacturing of oral solid dosages
• Expertise in authoring contributions to regulatory submissions
• Expertise with preformulation physical and chemical characterization, and corresponding analytical techniques, for new chemical entities, such as solubility (intrinsic vs kinetic, representative simulated gastric fluids), solid state stability, LogP/LogD, isoelectric point, pKa, particle size, bulk density, thermal properties, crystalline/amorphous forms, hygroscopicity, BCS classification
• Expertise in physical and chemical characterization of formulations, such as kinetic and thermodynamic solubility, stability, pH, drug loading, encapsulation efficiency, content uniformity, dissolution/release profile, disintegration profile, supersaturation, particle size, HLB, CMC
• Knowledge of analytical techniques related to the physicochemical characterization of new chemical entities and formulations, such as HPLC, DSC, TGA, PXRD, microscopy, FT-IR, pH, particle size, zeta potential, dissolution apparatus, disintegration apparatus
• Knowledge of drug delivery formulations to enhance peptide oral bioavailability, including understanding of state-of-the-art formulation techniques and current formulation landscape
• Ability to present results of work, interprets data, and draws conclusions regarding presented material and nature of work
• Excellent communication skills (both verbal and technical) and interpersonal skills

KNOWLEDGE, EXPERIENCE AND SKILLS

• Expertise in oral formulations and manufacturing
• 10+ years of experience in oral small molecule and/or peptide drug product development with MS/PhD or equivalent experience in a related scientific discipline
• Excellent writing and communication skills
• Strong soft skills and experience in interfacing with CMC team members and R&D project teams
• Strong leadership skills to lead and mentor oral formulation scientists
  The base pay range for this position at commencement of employment is expected to be between $165,000 and $190,000 / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
  Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides, icotrokinra and rusfertide, derived from Protagonist’s proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA expected in 2025. Icotrokinra (JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra’s joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies’ IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including the IL-17 oral peptide antagonist PN-881, an oral hepcidin program, and an oral obesity program

• Works closely with senior scientific team to advance the development of state-of-the-art drug delivery techniques for oral peptides
• Represent pharmaceutical sciences in cross-functional project teams
• Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations.
• Authors relevant sections of regulatory dossier for IND/NDA and IMPD for submissions.
• Responsible for selection, evaluation and monitoring of CDMOs for clinical trial material manufacturing and critical process development experiments
• Act as internal CDMO site lead for oral drug products, leading formulation scientists for tech transfer and process development
• Ability to travel domestically and internationally
• Coordinate with supply chain and drug substance teams to ensure timely delivery of clinical trial materials
• Responsible for oversight of outsourced formulation development efforts
• Design, implement, and analyze laboratory experiments to advance scientific knowledge of drug formulations
• Summarize and present original data to project teams and senior management
• Think critically and creatively and can work independently, such as determining and communicating resource needs for new research avenues or challenges
• Must have strong organizational and planning skills, with the ability to multitask in a dynamic environment