Scientist/Associate Scientist Peptide Formulation Job DescriptionProtagonist Therapeutics located in Newark, CA is seeking a formulation scientist to support their clinical programs. This person would ideally have experience in design and development of early stage clinical formulations and process development for different delivery routes, particularly oral and parenteral formulation, as well as experience in pre-formulation. Relevant experience could be related to biologics or small molecule, with peptide experience preferred. The ideal candidate would be able to provide formulation expertise and guidance to enable developing clinical formulations for early stage clinical trials. They should be able to design and execute experiments independently in the lab and collaboratively work across all departments involved in clinical development in addition to having a good working knowledge of formulation preparation for preclinical studies.
- The qualified candidate will be responsible for solid oral dosage form development for early and late-stage clinical trials
- 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) requirements
- The qualified candidate will be responsible for pre-formulation, formulation development, manufacture of clinical supplies and development of efficient and scalable manufacturing processes.
Required Skills - Experienced in formulation and process development of solid oral dosage forms.
- Expertise in site specific gastrointestinal drug delivery is a plus
- Hands on experience with modern delivery technologies to enhance bioavailability of small molecule or peptides
- Knowledge of basic analytical skills required: HPLC/MS, UV, DSC, TGA, XRPD, FTIR, DLS etc.
- Knowledge in pharmacokinetic data generation and interpretation
- Excellent communication skills and interpersonal skills are required.
Essential Functions - Works under supervision of directors to advance the development of state-of-the-art drug delivery techniques.
- Represents pharmaceutical sciences in cross-functional team meetings. Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
- Applies formulation development principles and techniques to products and problems. Working under general supervision, plans designs, implements and analyzes laboratory experimentation to advance scientific knowledge of drug formulations.
- 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 coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations
- This is a predominantly lab based position with possibility of international or domestic travel for manufacturing oversight at CDMOs
- Determine the optimal formulations for discovery compounds based on the delivery route, concentration requirements, and compatibility
- Provide feedback to chemistry and biology teams to integrate formulation early into the discovery process
- Experience with formulation laboratory techniques, such as sterile technique, pH, dissolution, lyophilization, spray drying
- Oversight of formulation screening studies in preclinical animal models
- Develop a formulation appropriate for Phase 1 clinical studies
- Generate and interpret pre-formulation data, such as logP, thermal analysis, moisture content, particle size, stability etc.
Experience And Skills - 8+ years of experience in peptide or small molecule development with BS in chemistry, engineering, pharmaceutics, or other related scientific discipline (or) 5-8 years with MS in chemistry, engineering, pharmaceutics, or other related scientific discipline (or) 3-5 years of experience in drug formulation with PhD in chemistry, engineering, pharmaceutics, or other related scientific discipline.
- Demonstrates excellent writing and communication skills
The base pay range for this position at commencement of employment is expected to be between $110K and $120K / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
