Associate Director

Associate Director, Peptide Platform Formulation Research and Development Job Description Protagonist Therapeutics located in Newark, CA is seeking an individual to provide scientific, technical and hands-on leadership in support of enabling technologies in peptide delivery and pharmaceutical development. The qualified candidate will Provide high level strategic knowledge in identifying and implementing enabling technologies for peptide delivery system and development of novel formulations Be responsible for peptide formulation development from lead optimization to clinical development. S/he should have experience and/or knowledge in formulation and pre-formulation research, formulation development, and process selection and enabling technologies. Provide technical input and oversight related to formulations including development work outsourced to CDMOs and contracting testing laboratories Be responsible for preformulation and research formulation activities Be responsible for development of scalable manufacturing processes and CDMO management for clinical supplies, and global regulatory CMC (INDs, IMPDs, NDAs) Required Skills Expertise in drug delivery formulations to enhance peptide oral bioavailability Formulation and process development of biologics and/or peptides to be delivered through oral and injectable routes including controlled release and depot formulations Knowledge of analytical skills related to identified formulation is required Excellent communication skills (both verbal and technical) and interpersonal skills Essential Functions Must have current knowledge of peptide delivery systems (oral and SC) Must have sound understanding of the principles and practices of chemistry or pharmaceutical sciences and be able to integrate and apply this knowledge effectively to formulate new peptides Works closely with senior scientific team to advance the development of state-of-the-art drug delivery techniques Represents pharmaceutical sciences in cross-functional project teams for both drug discovery and development Authors portion of regulatory submissions Plans, designs, implements and analyzes laboratory experimentation to advance scientific knowledge of drug formulations Presents, interprets, and draws conclusions from the data for presentations to the project teams and senior management Demonstrates ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes Thinks critically and creatively and can work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations Responsible for selection, evaluation and monitoring of CMDOs during clinical trial material manufacturing and critical process development experiments Ability to travel domestically and internationally is expected Knowledge, Experience And Skills 7+ years of experience in biologics and/or peptide pre-formulation & development with PhD in a related scientific discipline Expertise in drug delivery formulations to enhance peptide oral bioavailability Excellent writing and communication skills Strong soft skills and experience in interfacing with CMC team members R&D project teams The base pay range for this position at commencement of employment is expected to be between $175,000 and $205,000/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 stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and Janssen scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen 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. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.