For the Senior Scientist I – Peptide Analytical Chemistry position, we are seeking a highly motivated candidate who can conceive, implement, and execute novel scientific research and development. You will independently develop and optimize analytical methods and techniques to generate reliable and reproducible data in a timely manner, while demonstrating broad versatile technical expertise. You should possess a strong understanding of analytical chemistry core disciplines and support early phase development of New Chemical Entities (NCEs), with primary focus on synthetic peptides for both drug substance and drug product development across preclinical and clinical spaces. You will collaborate within the global Analytical R&D organization and with R&D cross-functional partners such as Pre-Clinical Safety (PCS), Process Chemistry, Process Engineering, Drug Product Development (DPD), Quality Assurance (QA), and CMC-Regulatory Affairs (RA).
Candidate should have strong technical background in analytical chemistry, excellent analytical problem-solving skills, and is capable of independently developing and troubleshooting analytical methods. This position will focus primarily on peptide drug product (DP) formulation development - supporting diverse oral peptide formulation platforms and IV formulation strategies.You may also support peptide drug substance development and characterization as needed. Opportunities to support small-molecule projects may also arise. Experience with peptide development, chromatographic analysis (such as HPLC or GC), and Mass Spectrometry is highly preferred.
Key Responsibilities
- Lead peptide drug product (DP) formulation development initiatives, providing analytical support for oral and IV peptide formulation platform development; work cross-functionally to advance projects through the development pipeline
- Provide analytical expertise to support diverse peptide formulation approaches, leveraging understanding of formulation technologies, stability science, and analytical characterization specific to peptide therapeutics
- Drive drug product analytical strategy development for peptide oral and IV formulations, including method development, testing procedures, and implementation of analytical control strategies
- Support drug substance characterization and development as needed to inform formulation strategies and contribute to cross-functional DS-DP understanding
- Support peptide and small-molecule product development with advanced analytics, method development, validations, technical data packages, and technical transfer documentation in support of regulatory requirements
- Utilize a range of analytical techniques to conduct research and development studies related to peptide and small-molecule drug substances, active pharmaceutical ingredients, intermediates, starting materials, and impurity profiling
- Independently and autonomously perform laboratory research and method development with minimal supervision, demonstrating high productivity and scientific initiative
- Initiate new areas of investigation that are scientifically meaningful, reliable, and can be directly incorporated into research or development programs
- Formulate conclusions, design follow-on experiments, and process, interpret, and visualize data based on multidisciplinary findings to facilitate project team decision-making
- Develop, test, and implement analytical control strategies to support advancement of drug discovery and development candidates
- Routinely demonstrate scientific initiative, creativity, and continuous improvement - never satisfied with the status quo, always raising the bar
- Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical products, especially therapeutic peptides, to further the understanding of emerging cGMP manufacturing process.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance, where applicable.