Address
Form of workSenior Scientist, Formulation Process Development
Position Summary:
Protagonist Therapeutics is seeking an experienced individual to provide scientific, technical and hands-on support of parenteral pharmaceutical development and manufacturing. The qualified candidate will support technical leads for late-stage drug product development, including technical contributions to process validation, drug product manufacturing, and global regulatory documentation.
Required Skills:
- Experienced in late-stage process and formulation development of sterile, parenteral dosage forms (pre-filled syringe and lyophilized products)
- Experienced in writing and reviewing technical documentation for GMP activities and process validation at partnering CMOs, such as master batch records, executed batch records, risk assessments, process characterization protocols and reports, change controls, and master validation plans, protocols, and reports
- Experienced in writing and reviewing drug product technical sections for global regulatory submissions, such as IND, IMPD, and NDA
- Experienced in person-in-plant responsibilities for technical and quality support of GMP operations
- Excellent communication skills (both verbal and technical) and interpersonal skills are required
Essential Functions:
- Technical reviewer and author for NDA-readiness activities related to parenteral drug products
- Works with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations
- Presents results of work, interprets data, and draws conclusions for sterile drug product manufacturing Process Development, characterization, and validation
- Thinks critically and creatively and can work independently, with particular focus on attention to detail and knowledge of regulatory and quality requirements for aseptic processes
- Serves as person in plant during clinical trial material manufacturing and/or critical Process Development experiments. Ability to travel domestically and internationally is expected, approximately 20% of work time.
Knowledge, Experience and Skills:
- Experience in parenteral formulation development and manufacturing, late-stage development required
- Experience with peptides preferred, small molecule or biologics also acceptable
- PhD with +5 years industry experience, MSc with +8 years industry experience; degree in Pharmaceutical Sciences or related field
- Demonstrates excellent writing and communication skills.
The base pay range for this position at commencement of employment is expected to be between $125,000 and $145,000/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. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at www.protagonist-inc.com.
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. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at www.protagonist-inc.com.
