- 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)
- 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
- 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
- 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
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Associate Director, Peptide Platform Formulation Research and Development - Newark, United States - Protagonist Therapeutics
1 week ago
Description
Associate Director, Peptide Platform Formulation Research and DevelopmentJob 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 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.
