Associate Scientist Analytical Development - Early Development

Role Summary

Associate Scientist Analytical Development - Early Development

Responsibilities

• Independently design, plan and execute studies on new development candidates to elucidate fundamental physicochemical properties and behaviors that enable lead candidate selection and downstream CMC development.
• Contributes to and drives solid state screening activities
• Contribute to preformulation activities, physicochemical profiling and analytical method development
• Contributes to a cross-functional Pharmaceutical Sciences team responsible for overseeing API salt and polymorph selection and subsequent development activities
• Develops non-GLP and GLP formulations based on the physical chemical properties of molecules and their route of delivery to support pre-clinical studies.
• Conducts biorelevant in vitro studies to assess potential in-vivo performance/impact of API and drug product changes during development lifecycle
• Responsible for significant technical leadership within a project and assist in project strategy development across projects within the department or cross functionally
• Interfaces with individual Pharmaceutical Science colleagues and cross functional project teams to ensure that development activities are consistent with physicochemical properties of API
• May serve as a technical expert/SME for mentoring of junior team members
• Responsible for integrating scientific/technical efforts around cross functional issues
• Plans and implements resolutions to technical problems/issues
• Supports local initiatives which may include technical or process related work streams
• Authoring of technical reports and contributes to regulatory filings

Qualifications

• Required: Bachelors degree in Pharmaceutics, physical organic chemistry, pharmacy, or related pharmaceutical science with 5+ years of relevant industry experience
• Required: Masters degree in Pharmaceutics, physical organic chemistry, pharmacy, or related pharmaceutical science with 3+ years of relevant industry experience

Knowledge and Skills

• Strong understanding of polymorphism and solid state screening techniques
• Strong understanding of solid state analytical techniques (XRPD/DSC/TGA/DVS)
• Skills in development of early formulations and basic analytical method development (HPLC, GC)
• Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and identify/implement possible solutions
• Teamwork -- Ability to work well in highly cross functional team environment
• Communication Skills - Able to expresses one’s self clearly and concisely within teams; documents issues and/or concerns concisely with colleagues; timely and effective communication of issues to supervisor; technical writing skills to support authorship of internal technical documents
• Organization – Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously
• Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information
• Resource Management - Ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
• Technical - strong knowledge of physicochemical and preclinical formulation theory along with hands on experience in multiple analytical techniques (DSC, TGA, HPLC, XRPD, Raman, PAT tools etc) and proven ability to work in a lab setting. Working knowledge of modalities outside of traditional small molecule (Oligonucleotides, Protacs) and in silico predictive tools/modeling highly valued

Education

• Required: Bachelors degree in Pharmaceutics, physical organic chemistry, pharmacy, or related pharmaceutical science with 5+ years of relevant industry experience
• Required: Masters degree in Pharmaceutics, physical organic chemistry, pharmacy, or related pharmaceutical science with 3+ years of relevant industry experience

Additional Requirements

• Travel: May require approximately 5-10% travel