Summary: Performs highly technical and advanced chemist duties in testing of full product line, raw materials, finished product, compliant stability and process validation samples, performs complex analytical procedures, completes pertinent documentation associated with testing, provides lead supervision and training to more junior staff; and performs related duties as assigned.
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.
- Complies with all current Good Laboratory Practices (cGLP), current Good Manufacturing
Practices (cGMP) and safety requirements and laboratory Standard Operating Practices
- Performs difficult analytical techniques such as complex procedures involving multiple
extractions, titration, timed reactions and normal phase HPLC with a minimum of
assistance and direction.
- Assists in providing training to new staff and ongoing training to current staff; assists in
providing work direction and review, and schedules work in absence of supervisor.
- Operates, maintains and troubleshoots all laboratory equipment, solves analytical
problems that involve troubleshooting equipment and laboratory method, and reports
method issues to Supervisor.
- Operates general analytical instruments for all routine testing (i.e., HPLC, GC, UV,
automatic titrator, and IR).
- Performs wet chemistry tests (i.e., LOD, pH, titration, etc.).
- Labels, transcribes and records data on approved report sheets, maintains appropriate
documentation (records and lab notebooks) of tests and assays, and performs all
necessary calculations associated with test analysis as required by SOP?s.
- Prepares written reports including investigations, validation studies, and
recommendations to revised laboratory test methods, SOPs, GTP?s and work requests.
- Trains all levels of new and current employees and provides direction in daily tasks.
- Reviews and audits analytical data from other laboratory personnel.
- Complies with good housekeeping and safety practices; ensures the collection and
proper disposal of hazardous waste from laboratory instruments.
- Participates in troubleshooting of analytical test methods and laboratory instruments.
- May provide direction on assignments.
- Takes part in the training program as a qualified trainer, as requested.
- Performs related duties as assigned.
- Reviews test methods.
Required Knowledge and Skills:
- 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 and GC.
- Analytical chemistry.
- Computer applications and programs related to laboratory applications (e.g., HPLC, FTIR, UV, LIMS, Lab Calc and GC).
- Sampling methods and quality control systems.
- Quantitative and qualitative techniques and math including statistics.
- Sample preparation techniques.
- Spectroscopic techniques and chromatographic systems.
- Compliance with DEA and site requirements regarding the handling, use and disposal of controlled substances.
- Reading, understanding and complying 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.
- Troubleshooting and problem solving laboratory equipment and methods.
- Accurately and precisely performing testing.
- Communicating clearly and concisely, in English, both orally and in writing.
- Establishing and maintaining cooperative working relationships with those contacted in
the course of work.
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 and electrical hazards. Work is performed in a laboratory environment
Minimum Qualifications: Bachelors of Science in Chemistry or related science from an accredited college or university and a minimum of nine (9) - thirteen (13) years of related laboratory experience in the pharmaceutical industry; or two (2) or more years of experience as a Chemist III; or an equivalent combination of training and experience.
- Apply at: http://hirelifescience.com/seeker_jobs.aspx?jobsID=475938&jobtitle=Chemist,%20Sr.