Associate Director, Peptide Platform Formulation Research and Development

at  Protagonist Therapeutics

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

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.

• 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