Senior Associate Scientist - Chemistry Analytical R&D

What You Will Achieve

As a Senior Associate Scientist in Analytical Research and Development GMP analytics group, you will take an active role in supporting drug release and stability testing by applying a variety of analytical methodologies to support physical and chemical characterization of highly potent drug substance and drug product.

How You Will Achieve It

• Perform laboratory work in support of analytical testing of pharmaceutical projects with some experience in any of the following analytical methodologies: chromatography, KF, spectroscopy and dissolution.
• Run analytical methods, test and release raw materials, and finished drug substance and drug products to support clinical release and use period extensions, and document experimental results.
• Effectively interact with drug substance/drug product project teams, quality assurance and regulatory CMC to support investigations, use/review period updates and release clinical supplies.
• Demonstrate proficiency with a wide variety of software and information systems.
• Interact effectively with peers and leaders as part of a multi-disciplinary team and thrive in a fast-paced environment.
• Demonstrate attention to detail, strong organizational skills, the ability to multitask and meet project timelines.

Qualifications

Must-Have

• BA/BS with at least 2 years of experience or MBA/MS with any years of experience.
• Ability to meet project milestones under general supervision, manage expectations for specific projects, ensure delivery submission-ready data and documentation.
• Experience in problem-solving skills and instrument troubleshooting.
• Demonstrated oral and written communication skills, especially adherence to laboratory GMP notebook practices.
• Experience with a wide variety of software and information systems (e.g. electronic lab notebooks, OneLab, CisPro, Empower and LIMS).
• Ability to work in a team environment in GMP laboratory environment performing experiments.
• Ability to perform data analysis, record results in electronic lab notebooks and effectively communicate in a team environment.
• Ability to adhere to safe laboratory practices.
• Good documentation skills with high attention to detail, strong organizational skills, team oriented, effective interpersonal and communication skills.
• Ability to work in environments requiring enhanced personal protective equipment (PPE).

Nice-to-Have

• Experience in the pharmaceutical industry.
• Experience working in a regulated environment.
• Experience with chromatography techniques (HPLC, GC, HPLC-MS, IC, FTIR, KF Titration).
• Potent compound handling experience.
• Use of isolators and gloveboxes.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.