Scientist

Summarized Purpose
Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analyses with increased independence. Performs a variety of advanced sample preparation and analytical procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in various formulations and/or biological matrices. Follows validated or experimental analytical procedures with periodic supervision. Responsible for reviewing and compiling results and comparing data against SOP acceptance criteria, methodology, protocol, and product specifications. Enters data into databases and reports, performing self-review prior to QC submission.
Essential Functions

• Performs complex sample preparation and analytical testing for pharmaceutical and biopharmaceutical compounds in various formulations and/or biological matrices for stability and analytical studies.
• Collaborates with multiple functional groups to meet business needs.
• Plans and organizes work with periodic supervision.
• Sets up and maintains analytical instrumentation.
• Trains on operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Ensures QA findings are addressed appropriately.
• Provides assistance and training to other team members.
• Resolves extraction and/or instrumentation issues independently or with assistance.
• Communicates project status to project leader.
• Performs assignments accurately, safely, and within established timelines.
• Reviews, interprets, and analyzes data for technical accuracy, quality, and compliance with protocols, methods, SOPs, client criteria, and GMP/GLP requirements. Performs self and peer review of data before QA submission and customer release.

• Bachelor’s degree or equivalent formal academic/vocational qualification.
• Minimum of 2 years of relevant laboratory experience.
• Equivalent combinations of education, training, and directly related experience may be considered.

• Demonstrated proficiency in analytical techniques such as HPLC, GC, MS, Dissolution Testing, Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, and TOC.
• Proficient in Microsoft Excel and Word.
• Ability to interpret data and perform trend analysis.
• Strong technical writing and documentation skills.
• Ability to independently optimize analytical methods.
• Strong problem-solving and troubleshooting abilities.
• Effective written and verbal communication skills.
• Strong time management and project management skills.
• Ability to work collaboratively in a team environment.