* Use/facility of commonplace analytical instrumentation (HPLC, GC, etc.) as well as of various instrumental methods (IR, NMR, XRPD, TGA, KF, etc.) and non-instrumental methods (wet chemical methods).
* Must demonstrate insight in understanding and design of experiments as well as of gathering/interpreting data in order to ensure right-first-time analytical activities.
* Must be fully capable of executing analytical methods validations/transfers/similar.
* Must be fully capable of writing analytical methods validations/transfers/similar protocols and reports documenting outcomes of experiments/exercises.
* Organize workflow and tasks to maximize laboratory efficiency (e.g., prioritize sample analysis, manage/assign tasks, preventative maintenance).
* Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
* Prepare samples for analysis and record data from analyses or experiments in a computer, log book, or laboratory notebook.
* Perform data audits in order to ensure accuracy of data and analytical processes.
* Maintain laboratory equipment and instrumentation (e.g., troubleshooting, conducting preventative maintenance, calibrating and repairing).
* Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.
Minimum Requirements
The successful candidate will hold a minimum BS degree in Chemistry (or closely related discipline) with minimum 3-5 years relevant experience in a cGMP-compliant pharmaceutical laboratory environment. Must have a broad background, strong comprehension, and demonstrated skills in analytical methods validation/transfers/similar. Some experience in analytical methods development is a strong positive..
Other Experience/Skills:
In-depth work experience in an analytical contract laboratory environment is a strong positive. Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful. Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.
Co.offers Custom organic synthesis, cGMP scale-up, Contract research, Molecular building blocks, Medicinal chemistry services and is a leader in fostering the commercial development of small molecule drug discovery and development in pharmaceutical, discovery platform, and biotechnology companies. The Co.offering parallels the drug discovery process and provides significant advantages at each step from lead discovery to lead optimization, chemical synthesis and scale-up of pharmaceutical intermediates as well as chemical process R&D.
CMO Strong in APIs.Low Cost Living.
REQUIREMENTS:
Minimum Requirements
The successful candidate will hold a minimum BS degree in Chemistry (or closely related discipline) with minimum 3-5 years relevant experience in a cGMP-compliant pharmaceutical laboratory environment. Must have a broad background, strong comprehension, and demonstrated skills in analytical methods validation/transfers/similar. Some experience in analytical methods development is a strong positive..
Other Experience/Skills:
In-depth work experience in an analytical contract laboratory environment is a strong positive. Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful. Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.
Co.offers Custom organic synthesis, cGMP scale-up, Contract research, Molecular building blocks, Medicinal chemistry services and is a leader in fostering the commercial development of small molecule drug discovery and development in pharmaceutical, discovery platform, and biotechnology companies. The Co.offering parallels the drug discovery process and provides significant advantages at each step from lead discovery to lead optimization, chemical synthesis and scale-up of pharmaceutical intermediates as well as chemical process R&D.