Summary: Performs advanced testing of drug products, calibration, qualification and maintenance of laboratory instrumentation; provides lead supervision and training to more junior staff; and performs highly technical and specialized chemist duties.Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Performs more complex chemistry testing.
- Assists in providing training to new staff and ongoing training to current staff; assists in providing work direction and review.
- Conducts calibration, qualification and maintenance of laboratory instrumentation (i.e., pH meter, HPLC, dissolution equipment, etc).
- Operates general analytical instruments during raw material testing (i.e., HPLC, GC, UV, automatic titrator, IR, AA and TLC).
- Performs wet Chemistry tests on raw materials (i.e., LOD, pH, titration, etc.).
- Prepares standard and sample solutions as required by the test methods.
- Maintains appropriate documentation (records and lab notebooks) as required by SOP's.
- Complies with all current Good Laboratory Practices (cGLP), current Good Manufacturing Practices (cGMP) and safety requirements, laboratory Standard Operating Practices(SOPs) and Company policies and procedures.
- Complies with good housekeeping and safety practices.
- Participates in troubleshooting of analytical test methods and laboratory instruments.
- Performs related duties as assigned.
- Takes part in the training program as a qualified trainer, as requested.
- Assists in reviewing test methods.
- Perform analysis on intermediate and finished product.
Required Knowledge and Skills:Knowledge of:
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
- Up-to-date instrumentation and the following instruments: UV/IR, HPLC, GC and TLC.
- Chemistry and wet chemistry.
- Computer applications and programs related to laboratory applications (i. E., HPLC, FTIR, AA).
- Sampling methods and quality control systems.
- Math including statistics.
- Sample preparation techniques.
- Spectroscopic techniques and chromatographic system.
- Compliance with DEA and site requirements regarding the handling, use and disposal of controlled substances.
- Reading, writing and speaking English.
- Reading, understanding and compliance with Company policies and procedures, including safety rules and regulations.
- Operating a personal computer.
- Providing leadership and training to all levels of the Chemist position.
- Assisting in troubleshooting and problem solving.
- Accurately and precisely performing testing.
- Chemist license preferred in Puerto Rico.
Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 50 pounds, vision to monitor and moderate to loud noise levels. Incumbents may be exposed to or work with toxic materials, toxic gases, electrical hazards, dangerous tools and equipment. Work is performed in laboratory environments. Incumbents must be able to use personal protective equipment, (e.g. respirators, gloves, etc.).Minimum Qualifications: Bachelors of Science in Chemistry or related science from an accredited college or university and a minimum of five (5) – eight (8) years of related laboratory work experience; or two or more years of experience as a Chemist II; or an equivalent combination of training and experience.