Scientist- Analytical Research and Development

How You Will Achieve It

This colleague will be responsible for developing analytical strategies in support of pharmaceutical drug substance and/or drug products during all development phases, including supporting manufacturing process development, developing, validating and transferring analytical methods, designing stability studies for shelf life assignments, and developing impurity control strategies.

• Collaborates with colleagues and subject matter experts to assess the most appropriate analytical approach to support project activities, including use of computational predictive tools, modelling software and data visualization tools where appropriate.
• Perform lab work and delegate responsibilities and review peer lab work as appropriate.
• Through effective communication and collaboration with multidisciplinary team members, this colleague will have the opportunity to present data at team meetings and be actively involved in solving technical challenges that arise during development.
• The candidate must be able to collaborate with and mentor peers as well as effectively interact with colleagues at all levels of the organization.
• Author relevant sections of global regulatory submissions in support of new drug approvals.
• They will also prepare technical reports, critically review data, and may evaluate new instrumentation and analytical techniques/approaches.
• Proficient with a wide variety of software and information systems and the curiosity to continue learning new techniques to solve complex analytical problems.
• Proficient with a breadth of relevant methodologies such as, chromatography, dissolution, IR spectroscopy, mass spectrometry, particle size analysis and NMR, with expertise in one or more of these techniques.

Qualifications

Must-Have

• MS in Analytical Chemistry or related field with 4-6 of years of experience or BS with 6-8 years of experience
• Demonstrated ability to meet timelines with minimal supervision and experience leading multi-disciplinary teams.
• Demonstrated ability to learn new techniques and solve complex analytical problems.
• Demonstrated oral and written communication skills, including visualization of data and drafting reports.
• Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills.
• Proficient with a breadth of relevant methodologies such as, chromatography, dissolution, IR/Raman spectroscopy, mass spectrometry, particle size analysis, and NMR, with expertise in one or more of these techniques.

Nice-to-Have

• Experience in the pharmaceutical industry.
• Prior experience with analysis of peptide therapeutics.
• Experience with trace level impurity analysis
• Understanding and prior experience in global regulatory submission processes.
• Familiarity about separation technology including liquid chromatography, gas chromatography, SFC, etc.
• Experience with a wide variety of software and information systems utilized in the pharmaceutical industry (eg LIMS, Chromatographic Software, Veeva, electronic notebooks).
• The ability to use computational predictive tools, modelling software or data visualization tools.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

PHYSICAL/MENTAL REQUIREMENTS: Ability to perform calculations and data analysis is required. This role requires the use of laboratory equipment and working in laboratories. Some lifting may be required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS: Some travel may be required. Relocation support available. Work Location Assignment: On Premise.