FIND INTERNSHIPS

Director, Peptide Platform Formulation Research And Development

Posted on Nov. 28, 2024 by Protagonist Therapeutics

Newark, United States of America
$175000.0 - $235000.0

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

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)
Plans, designs, implements and analyzes laboratory experimentation to advance scientific knowledge of drug formulations
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
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
Knowledge of cGMP principles and CDMO oversight for GMP manufacturing is preferred
Authoring contributions to regulatory submissions is a plus
Ability to travel domestically and internationally is expected

Knowledge, Experience And Skills

10+ years of experience in small molecule, 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 $195,000 and $235,000 / 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 in The New England Journal of Medicine in 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.

Advertised until:
Dec. 28, 2024

Are you Qualified for this Internship Role?

Click Here to Tailor Your Resume to Match this Job