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:
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.