Analytical R&D Chemist performs testing and solution preparations, performs equipment & instrumental calibrations and maintenance, communicates between departments when reporting results and executes test protocols as assigned by management. The analyst is also responsible for assisting in writing protocols & reports, as well as sampling raw material, finished goods, stability samples and additional samples as assigned.
Responsibilities include but are not limited to:
- Performs chemical testing on raw material, in-process, finished good and stability samples.
- HPLC, UPLC, Gas Chromatography (GC) and wet chemistry testing.
- Performs impurity, supplier approval, and research testing.
- Performs laboratory equipment calibrations/performance checks.
- Troubleshoots and maintains laboratory instruments.
- Assists in the performance of qualifications and validations of instruments and test methods.
- Laboratory OOS, deviation investigation writing.
- Revise laboratory Standard Operating Procedures (SOPs).
- Assists in writing protocols and reports.
- Executes test protocols, as assigned by management.
- Leadership: Assist supervisor with scheduling and overseeing day to day tasks/projects.
- Trains new analysts on laboratory skills and functions.
- Perform other duties as required to fulfill department and business needs.
Qualifications:
- BS / MS in Chemistry, Biochemistry or related discipline is preferred.
- Preferable to have some experience in pharmaceutical industry Quality Control environment supporting US FDA pharmaceutical products.
- Familiarity with Good Manufacturing Practices (cGMP’s) and Good Laboratory Practices (GLP) a must!
- Possess an understanding of cGMP/compliance requirements for pharmaceutical products ideal.
- Expertise in OOS/OOT/Atypical resolution, deviations, change controls, root cause analysis, and monitoring CAPA effectiveness would be a desirable.
- Experience with an ICH compliant stability program with the ability to perform statistical analysis to identify trends.
- Experience with electronic systems such as LIMS is an advantage.
- Knowledge of relevant FDA guidance documents.
- Ability to work independently with minimum guidance.
- Excellent verbal and written communication skills.
Position Type/Expected Hours of Work:
This is a full-time on-site position, and hours of business operations are Monday through Friday, 8:30 a.m. to 5 p.m. Must be available to work extended hours as needed to meet deadlines, including weekends from time to time.
Med-Pharmex is an Equal Opportunity Employer. The policy Med-Pharmex is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual’s age, race, color, sex, religion, national origin, disability, protected veteran status, sexual orientation, genetic information, or any other protected category recognized by state and federal laws.
