Senior Scientist, Solid Oral Formulation

Job Description

Protagonist Therapeutics located in Newark, CA is seeking an expert in solid oral formulation and process development. The ideal candidate should be able to provide scientific, technical and hands-on leadership in support of pharmaceutical development of oral dosage forms, including the following:

• Experience with design and development of solid oral dosage forms for early- to late-stage clinical development
• Experience with drug discovery lead optimization, preformulation, and formulation development
• Experience with process development and scale-up from drug discovery candidate through to manufacturing clinical materials
• Experience with development of efficient and scalable manufacturing processes and oversight of drug product development and GMP manufacturing at external CDMO
• Experience and/or knowledge of global CMC regulatory submissions (INDs, IMPDs, NDAs)

Required Skills

• Experienced in oral formulation development, including expertise in pharmaceutical excipients and their use in oral formulation
• Well-versed in modern oral delivery technologies and complex formulations to enhance oral bioavailability of small molecule or peptides; expertise in site-specific gastrointestinal drug delivery is preferred
• Experienced and/or knowledge of different types of oral dosage forms and their formulation, such as immediate release tablets, delayed or controlled release tablets, hard-shelled capsules, liquid-filled capsules, softgels
• Experienced in process development and manufacturing of solid oral dosage forms, including tableting, capsule filling, coating, granulation (wet and dry), and blending
• Expertise in physicochemical characterization of solid oral dosage forms, such as disintegration, dissolution, assay, friability, tablet hardness, content uniformity, stability, excipient compatibility
• Experienced in cGMP principles, documentation, manufacturing, and oversight
• Knowledge of packaging materials and requirements for solid oral dosage forms
• Knowledge of principles of experimental design for process scale-up and qualification, such as DoE and QbD principles
• Knowledge of physical and chemical characterization of new chemical entity as applicable to oral pharmaceutical development, such as solubility, LogP/LogD, particle size, bulk density, hygroscopicity, crystalline/amorphous forms, salt form, stability (solid-state, photostability, shear), BCS classification
• Knowledge of basic analytical techniques, such as HPLC, DSC, FT-IR, TGA, microscopy
• Knowledge of pharmacokinetic data generation and interpretation as it pertains to formulation selection and bioequivalency is preferred
• Excellent communication skills (both verbal and technical) and interpersonal skills

Essential Functions

• Must have sound understanding of the principles and practices of pharmaceutical sciences and be able to integrate and apply this knowledge effectively to formulate new chemical entities
• Work under supervision to advance the development of state-of-the-art oral drug delivery techniques
• Represent pharmaceutical sciences in cross-functional team meetings
• Meet with research groups for project meetings and prepare data for presentation
• Author portion of IND/IMPD submissions
• Apply formulation development principles and techniques to new products and problems
• Work under general supervision to design, implement, and analyze laboratory experiments to advance scientific knowledge of oral dosage forms
• Interpret data, draw conclusions, and present results regarding pharmaceutical development of oral dosage forms
• Maintain and improve knowledge of principles and theories of oral pharmaceutical development, applying said knowledge to support company interests
• Think critically and creatively for troubleshooting challenges
• Can work independently with strong organizational and planning skills
• Work collaboratively with external CDMO partners for oral pharmaceutical development and manufacturing
• Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations
• Serve as person-in-plant during clinical trial material manufacturing and/or critical process development experiments
• Ability to travel domestically and internationally is expected

Knowledge, Experience And Skills

• 7-10+ years of experience in peptide or small molecule development with MS/PhD in a related scientific discipline.
• Demonstrates excellent writing and communication skills.

The base pay range for this position at commencement of employment is expected to be between $165,000 and $185,000/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 biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced Phase 3 stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and JNJ scientists jointly discovered PN-235 as part of Protagonist's Interleukin-23 receptor (IL-23R) antagonist collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program for polycythemia vera (PV). The randomized portion of the Phase 2 REVIVE study has been successfully completed, and results were published inTheNew England Journal of Medicinein February 2024. The open-label extension (OLE) component of Phase 2 REVIVE study is ongoing, followed by an additional 2-year long-term extension (LTE) THRIVE study. Enrollment has been completed in the global Phase 3 VERIFY study of rusfertide in polycythemia vera. Rusfertide is being co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda announced in January 2024.