Assoc Research Scientist – qNMR, HPLC, KF

Key Responsibilities

• Collaboratively design and oversee drug substance process development analytical activities for early phase development.
• Identify critical in-process-control issues and develop appropriate IPC methods.
• Serve as the subject matter expert for drug substance analytical development with contract manufacturing and testing labs.
• Develop analytical methods, suitable early-stage pharmaceutical development.
• Understand chemical development and solid-state development to identify and document critical factors that impact quality, method performance, or associated analytical development activities.
• Present to cross functional teams and effectively communicate critical analytical issues and solutions.

Education and Experience

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar. ARS: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+ years) OR Masters degree and previous experience (comparable 4+ years) OR PhD and previous experience (comparable 2+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient.

Knowledge, Skills and Abilities

• Excellent verbal and written communication skills are essential.
• Experience and/or working knowledge of control strategy development.
• Good understanding of cGMP, ICH, FDA, and USP guidelines, including ICH guidelines on the control of impurities (organic, residual solvents, and elemental, DNA reactive (including ICH M7 option 4 / in silico control), and nitrosamines).
• Skilled in modern analyses for small molecule pharmaceuticals, particularly chromatography (HPLC/UPLC), KF, qNMR etc.
• The ability to work successfully in both a team/matrix environment as well as independently.
• The ability to work in a fast-paced environment, manage priorities, communicate outcomes and maintain timelines for multiple projects.

Working Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.