Position Summary:
Protagonist Therapeutics is seeking an individual to provide scientific, technical and hands-on leadership in support of parenteral pharmaceutical development.
The qualified candidate will be responsible for parenteral drug product development from lead optimization to clinical development and through commercialization, and should have experience and/or knowledge in pre-formulation, formulation development, and process selection and scale up, oversight of GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs).
The qualified candidate will be responsible for lead optimization, API form selection/characterization, pre-
formulation, formulation development, manufacture of clinical supplies, development of efficient and scalable sterile manufacturing processes and CDMO management.
Required Skills:
Experienced in formulation and process development of sterile, parenteral dosage form development from lab to commercialization (e.g., hydrogels, emulsions, suspensions, injectable depot, liposomes, microspheres, nano-suspensions, etc.)
Experienced in developing phase-appropriate drug product development plans and manage activities at
CDMOs.
Knowledge of basic analytical skills required: HPLC, UV, solid state characterization.
Knowledge in pharmacokinetic data generation and interpretation
Excellent communication skills (both verbal and technical) and interpersonal skills are required.
Essential Functions:
Must have sound understanding of the principles and practices of pharmaceutical sciences and be able to integrate and apply this knowledge effectively to formulate new chemical entities.
Working under general supervision, plans, designs, implements and analyzes laboratory experimentation to
advance scientific knowledge of drug formulations.
Applies formulation development principles and techniques to products and problems.
Serves as person in plant during clinical trial material manufacturing and/or critical process development experiments.
Works with the team to advance the development of state-of-the-art drug delivery techniques/devices.
Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations.
Represents pharmaceutical sciences in cross-functional team meetings.
Authors relevant sections of regulatory dossier for IND/NDA and IMPD for submissions.
Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
Maintains full working knowledge of principles and theories, applying such knowledge to the direction that
supports company interests.
Demonstrates emerging 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 travel domestically and internationally is expected
Knowledge, Experience and Skills:
10+ years of experience in peptide, biologics or small molecule parenteral formulation development and manufacturing with MS/PhD in Pharmaceutical Sciences
Demonstrates excellent writing and communication skills.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical-stage biopharmaceutical company with multiple peptide-based new chemical entities in different stages of development. Discovered through our proprietary technology platform, our differentiated assets are designed to impact key biological targets and pathways, providing the potential to add new indications, and expanding our pipeline efficiently including orphan and large-market opportunities that address areas where there is significant unmet medical need. Currently, we have five novel peptidic assets, PTG-300, PTG-200, PN-232, PN-235, and PN-943 in clinical development.
Protagonist is headquartered in Newark, CA. For further information, please visit www.protagonist-inc.com.
