The Analytical Development Associate II is responsible for performing analytical chemistry research and/or development in collaboration with others to develop assays based on new and existing methodologies. Assists in developing and validating testing methodology used to control raw materials, in-process materials, and final drug products. Helps establish, validate and document new or existing analytical methods. Conducts testing of analytical samples and/or GMP samples for the development of drug candidates, analytical methods and formulation development. Participates in the preparation of investigations, summaries and reports as relating to analytical methodology. Conducts work in compliance with cGMP, safety and regulatory requirements. Provides analysis and evaluation of material and products at all stages of development process. The Analytical Development Associate II compiles data for statistical analysis to trend analytical method performance, to define specifications for controlling drug products and to define analytical method validation criteria. The Analytical Development Associate II authors and revises analytical test methods/procedures, method development/validation protocols and reports; and may present and/or summarize method development activities and conclusions.

_*_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 and alerting a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions.

 

EDUCATION AND/OR EXPERIENCE:

• Bachelor’s Degree in Analytical Chemistry (or similar) required.
• Minimum of 2-5 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.

SUPERVISORY RESPONSIBILITIES: none

QUALIFICATIONS:

• 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.
• Experience with analytical method development and validation.
• Demonstrated ability to 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.

COMPUTER SKILLS:

• Experience with MS Suite

CERTIFICATES, LICENSES, REGISTRATIONS: none required

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.

PHYSICAL DEMANDS:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• 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.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

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.