Analytical Scientist III

About the role

Laboratory position focused on the development and validation of analytical methodology to support research projects involving testing of pharmaceutical components and drug products. This role involves designing and completing experiments, providing scientifically sound recommendations based on data, and contributing to product development.

Responsibilities

• Develop new analytical methods using innovative solutions for actives, excipients, drug release, residual solvents, and product development.
• Validate analytical methodologies following ICH guidance.
• Execute complex experiments in support of R&D for development and validation of processes with minimal supervision.
• Identify creative and innovative solutions for non-routine analytical tasks.
• Improve analytical applications by implementing new techniques.
• Interpret problems, make scientific judgments based on experimental data, and take appropriate actions to resolve issues.
• Write and review protocols, reports, SOPs, specifications, and test procedures.
• Compile documentation to support regulatory submissions such as ANDAs or NDAs.
• Adhere to laboratory SOP guidelines, GMP requirements, and safety rules.
• Maintain analytical instrumentation through proper performance and maintenance.
• Train junior scientists and QC chemists as necessary.
• Demonstrate problem-solving abilities and provide recommendations.
• Work as a team member to achieve outcomes while adhering to the Code of Conduct, Business Ethics, and all regulatory, compliance, and safety requirements.
• Perform all work in alignment with company values: Collaboration, Courage, Perseverance, and Passion.
• Perform other relevant duties as assigned.

Requirements

• Bachelor’s degree (B.S.) in chemistry or a related field; Master’s degree (M.S.) or Ph.D. preferred.
• Proficiency in using analytical equipment such as UV/Visible and Infrared spectrophotometers, automatic titrators, pH potentiometers, dissolution apparatus, HPLC, GC, GC/MS, LC/MS/MS, and other techniques as needed.
• Strong verbal and written communication skills, including interpretation of experimental results and technical report writing.
• Broad knowledge of methods development for Active Pharmaceutical Ingredients, intermediates, excipients, and drug products.
• Ability to identify problems and take appropriate actions based on available information.
• Strong organizational skills and ability to plan and prioritize work to meet deadlines.
• Proficiency in computer hardware, software, and databases such as MS Office, TrackWise, Empower, or other analytical instrumentation software.
• Demonstrated accuracy, thoroughness, and adherence to high-quality standards related to cGMPs.

Qualifications

• At least five (5) years of experience in a pharmaceutical laboratory (for B.S. degree holders).
• At least two (2) years of laboratory experience (for M.S. degree holders).