Associate Scientist

Job Description

Associate Scientist is responsible for performing analytical research and development work focusing on the analytical activities for product/process development and contribute towards the successful regulatory filings and approvals to launch new products.

• Work/assist as per business needs on method development, method transfer, method verification and method validation under direct and continuous supervision
• Routine release and stability testing in support of clinical development and registration activities
• Work closely with the product development and process transfer teams to provide analytical results in timely fashion and with proper data interpretation for drug product development through feasibility/development, tech transfer, registration, and validation phases of the assigned projects

Minimum Education And Experience Required To Perform The Job

• B.S in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry)
• At least 1 year of analytical testing/research experience using HPLC/GC/UV, etc.

Knowledge/Skills Requirements

• Understand analytical chemistry calculations such as concentrations, molarity, Beer’s Law, reference standard purity on as is, anhydrous, or dry basis etc.
• Be able to perform basic statistical data analysis.
• Have good laboratory notebook documentation skills and clear/legible handwriting.
• Have good hands-on ability and be a quick learner.
• Able to multi-task with high efficiency and work in a fast-paced environment to meet deadlines.
• Able to coordinate and prioritize to support manufacturing and project timelines.
• Able to work well under pressure and maintain efficiency both on an individual and team basis.
• Able to communicate effectively.
• Proficient in English.
• Understand and follow all laboratory safety processes and procedures and the ability to work safely with chemicals of varying potency.
• General computer literacy including use of Microsoft Word, Excel, and Power Point, etc.
• Able to perform analytical testing while standing for long periods of time.
• Accurate testing and execution of protocols first right time to meet customer and production timelines.
• Basic understanding and knowledge of analytical chemistry and chromatographic techniques (e.g., LC/GC/dissolutions) and spectroscopic (e.g., UV) analysis.
• Basic understanding and ability to perform/assist photostability studies (ICH Q1B), dose dump studies/solubility/polymorphism and hygroscopy studies required for RA filing on DS/DP as needed.
• Able to understand and follow ICH guidelines (ICH Q1, Q2, Q3 etc.) including other regulatory guidelines.
• Adhere and perform all lab job duties/responsibilities according to applicable SOP's related to DEA scheduled drugs, safety, waste management and housekeeping and work with the team in improvement of the processes and procedures.