Category: Scientific & Clinical
Under supervision, incumbent is responsible for implementation of analytical procedures in support of research, GMP production, reference material program, and stability testing. The Analytical Chemist is expected to contributes to the assigned challenges and to offer recommendations to staff.
- Support manufacturing campaigns and routine testing by performing sample analysis and summarizing results.
- Performs testing for qualification and re-qualification of reference materials.
- With guidance from experienced team member, performs method development activities, writes test method and method qualification/validation protocols.
- Independently carries out experiments in the laboratory.
- Under supervision, performs evaluation, qualification and transfer of analytical methods.
- Performs maintenance, calibration and some troubleshooting of the equipment and instruments.
- Stays abreast of current technology and developments with emphasis on LC and GC applications in pharmaceutical industry.
- Documents all analyses per SOPs.
- Prepares high quality written documentations (notebooks, CoTs, summary reports, and analytical procedures).
- Communicates effectively in verbal and written form on research results and plans.
- Participates in team discussions and assists in achieving team goals.
- Volunteers to assist with task not directly related to a specific project.
- Demonstrates initiative in handling responsibilities.
- Contributes to the technical growth and continuous improvement of the department and company by actively participating and supporting initiatives.
- Participates in self-development activities.
- To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed
- While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
- Must be able to lift and/or move up to 50 pounds.
- Specific vision abilities include: near, distance, peripheral, color perception, and the ability to adjust focus.
- Regularly works with moving mechanical parts and may work with toxic or caustic chemicals. The work may be performed in humid areas with low or high temperatures.
- Will be expected to work long shifts, and there is potential for night and weekend coverage.
- BS in Chemistry or related degree
- 1-2+ years related experience in analytical development (R&D and method qual/validation) environment within pharma industry
- Experience with common analytical techniques such as NMR, UV< KF, FTIR, HPLC, GC
- Knowledge of MS Project a plus