Associate Scientist

Associate Scientist

Onsite position - shift - Mon-Fri 8am - 5pm with some occasional OT. The 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. Analytical Associate Scientist work/assist as per business needs on method development, method transfer, method verification and method validation under direct and continuous supervision along with routine release and stability testing in support of clinical development and registration activities.

The candidate will 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) with at least 1 year of analytical testing/research experience using HPLC/GC/UV, etc.

Knowledge/Skills Requirements:

• Understand analytical chemistry calculations such as concentrations (Area%, %w/w, ppm, μg/mL, etc.), 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.
• Ability to multi-task with high efficiency and work in a fast-paced environment to meet deadlines.
• Ability to coordinate and prioritize to support manufacturing and project timelines.
• Ability to work well under pressure and maintain efficiency both on an individual and team basis.
• Ability 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.
• Ability 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.
• Ability 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.