Scientist I (ARD)

Role overview

Analytical and laboratory duties

• Execute methods for in-process control, release testing, and stability monitoring of bulk drug substances and drug products under cGMP.
• Set up instrumentation according to written test methods and maintain working knowledge of laboratory equipment and scientific methods.
• Perform work safely, accurately, and on schedule according to SOPs and supervisor instructions.
• Analyze technical information, compile and interpret results, and communicate findings to supervisors.
• Maintain laboratory notebooks and computer files, including LIMS records; perform routine laboratory procedures and maintain supplies and equipment.
• Participate in cGMP activities, project meetings, technical discussions, and safety, health, and environmental programs.
• Assist with laboratory investigations and documentation for OOS results, atypical events, deviations, and CAPAs.
• Assist with SOPs, methods, qualification protocols, and other standard documents; prepare development reports with guidance.
• Review others’ test data and witness notebooks when assigned; update project status and timekeeping systems.

Qualifications

• B.S. or B.A. in Chemistry with at least two years of related industry experience.
• Working knowledge of experimental design and chemistry supporting method development.
• Working knowledge of analytical techniques and instrumentation such as NMR, IR, mass spectrometry, and HPLC; hands-on experience in HPLC, GC, or similar techniques.
• Working exposure to cross-functional techniques, including organic chemistry.
• Able to follow SOPs and basic regulatory requirements; good understanding of FDA and cGMP regulations.
• Able to operate laboratory equipment and computers and follow detailed scientific procedures with supervision.
• Strong problem-solving, attention to detail, teamwork, and written and verbal communication skills.
• Familiarity with Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel is listed.

Working approach

• Actively and positively engage with the team and support process improvements.
• Show initiative and interest in learning techniques and tests; communicate issues to senior staff or management.
• Take direction from experienced scientists, ask questions, and participate in technical discussions.

Work environment

• Laboratory role involving analytical testing, laboratory equipment, and maintaining a clean and safe workspace.