The Scientist is a technical, mostly lab-based position that will support the Principal Scientist in the research and development of pre-clinical and early clinical-stage candidate formulations using Xeris’ proprietary technology for the delivery of small molecule and peptide/protein therapeutic agents. Will participate in research and development activities from inception through preclinical manufacture/screening, technology transfer to selected CDMO’s, and early cGMP manufacture. This position will work closely with Quality and CMC counterparts.
Additional aspects include developing (or overseeing the development of) necessary analytical methods, specification development, and assessment and management of stability data/programs. This position will bridge early-stage R&D (focused on a mechanistic understanding of formulation stability) with later-stage drug product development (focused on meeting all scientific requirements to support regulatory submissions).
- Perform mechanistic studies aimed at understanding drug molecule conformation, activity, and degradation pathways in non-aqueous solvent systems.
- Identify optimal formulation conditions to achieve a specified target product profile.
- Prepare and supply finished drug product (non-GLP, GLP) for internal and external studies.
- Conduct Quality-by-Design formulation optimization studies using design of experiments.
- Participate in the development of analytical methods to support formulation development activities.
- Assist in the design of stability studies, analyze and summarize analytical data, and contribute to storage condition recommendations and product expiry/shelf life.
- Facilitate technology transfer activities for non-GMP and cGMP drug product manufacture.
- Write and review technical protocols and reports to support regulatory filings.
- Assist in writing and reviewing provisional patent applications to generate new IP (Intellectual Property).
- Ph.D. in Pharmaceutical Sciences, Drug Development or related field (e.g. Chemistry, Biochemistry).
- Direct experience or working understanding of analytical methods relevant to drug product development (e.g. HPLC, MS, NMR, FTIR, ITC, SPR).
- Experience with the development of sterile parenteral products and the documentation requirements for supporting GLP pre-clinical studies.
- Demonstrated experience in pre-clinical and early clinical product development.
- Solid understanding of GLP and GMP regulations with a working understanding of ICH and FDA guidelines.
- Experience developing IP and filing patent applications.
- Direct experience with the development of early phase clinical CTM specifications.
- Communicates clearly and effectively across multiple functions and levels to foster a friendly and collaborative work environment.
- Competencies: Excellent problem-solving skills, Flexibility, Thrives in a fast-paced environment, Written and Verbal Communication skills, Proactive, Teamwork / Collaboration, Results-Oriented.
- Up to 15% domestic travel may be required.
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.