Analytical Development Associate III
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The Associate is responsible for performing analytical chemistry research and/or development in collaboration with others to develop assays based on new and existing methodologies. Assist in developing and validating testing methodology used to control raw materials, in-process materials, and final drug products. Conduct testing of analytical samples and/or GMP samples for the development of drug candidates, analytical methods and formulation development.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Operates analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF).
- Statistically and critically analyzes data to support drug candidate and analytical method development and validation.
- Summaries method development and validation activities into regulatory filing appropriate documentation.
- Participates in Laboratory and/or Quality Investigations as relating to analytical methodologies.
- Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
- Participates in the construction and/or revision of Analytical Test Methods.
- Assists in the writing and updating of analytical test procedures.
- Responsible for identifying, alerting and proposing solutions to issues on instruments and/or test executions; leads and implements recommended solutions and/or corrective actions.
- Independently organizes work flows to accomplish objectives, provides guidance and support to colleagues as needed, promotes new policies and programs tactfully and authentically, and may author/document performance reviews and/or evaluations.
Education and/or Experience:
- BS in Analytical Chemistry (or similar) required.
- Minimum of 3-5 years of experience with analytical method development, analytical method transfer and/or analytical method validation activities
- Experience working in a cGMP regulated environment preferred.
- Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred.
- Extensive experience with executing a variety of analytical test methods, preparing protocols that comply with statistical randomization principles (i.e. DOE), auditing data, troubleshooting instrumentation, trending data and statistical analyses required.
- Demonstrated ability to lead projects and/or teams independently.
- Extensive experience with analytical method development and validation.
- Demonstrated ability to lead and evaluate analytical methods as potential root causes for supporting cGMP investigations.
- Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred.
- Familiarity with executing Standard Operating Procedures in a GMP setting preferred.
- Chromatography skills using Empower and/or ChemStation required.
- Critical understanding of the importance of documentation and data traceability required.
- Working knowledge of cGMP’s and their application to Quality Control preferred.
Other Skills and Abilities:
- Excellent oral and written communication skills.
- Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities.
- Demonstrates dedication to documentation/data traceability and strong attention to detail.
- Demonstrates appropriate safety consciousness.
- Ability to lift up to 20 lbs.
- Ability to stand for long periods of time.
- This position requires minimal travel; average travel for this position is ≤10% with some variation based upon the demands of the business imperatives.
Ability to work safely and conscientiously in a laboratory environment; wear appropriate personal protective equipment; communicate with others in the laboratory to mutually ensure continued safe laboratory practices.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.