Senior Analytical Chemist

1 month ago

Los Angeles, United States Xseer Pharmaceuticals Full time
Job DescriptionJob Description

Overview of Position
The 503B Senior Analytical Chemist is responsible for leading/performing lab activities necessary for implementation of Chemistry Analytical Support of 503B product commercialization/ analytical transfer.
Responsibilities:

 Responsible for analytical method validation, verification, transfer, implementation of new methodology, and providing trouble shooting for analytical methods utilized in QC Chemistry.
 

    
 Lead analytical testing required for analytical method validation, verification, and / or transfer
for commercialization of 503B projects for Chemistry.
 Responsible for performing or managing the chemical and physical testing associated with
assigned projects to include implementation of new 503B analytical methods to be utilized
in QC Chemistry.
 Responsible for review of 503B and commercial laboratory SOPs, Specifications, method
validation, verification, and / or transfer protocols, and summary reports.
 Responsible for review of data generated during the execution of 503B laboratory method
validation, verification, and / or transfer protocols, and summary reports.
 Responsible for directing and review of Chemistry 503B & commercial conducted lab
investigations of OOS/OOT results.
 Performs specific routine analyses of samples of raw materials, in-process samples during manufacturing, and finished products according to established procedures, to determine conformance to defined specifications for a particular product, including laboratory testing, collecting stability data, conducting visual analysis, measurement tests, rejecting unacceptable materials, and approving acceptable materials.
 Responsible for troubleshooting, maintenance, and calibration of laboratory equipment.
 Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.
 Performs testing per established product specifications using any associated chemistry
instrumentation (HPLC, IR, UV, GC).
  Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or
 regulatory requirements.
 Provide feedback on systems and analytical procedures to promote continuous improvement and
 enhancement of compliance posture.
 Ensure all drug products are tested in accordance with the highest standards of Good
 Manufacturing Practice (cGMP), ICH guidelines, and according to regulatory guidelines, laws and
 Standard Operating Procedures (SOPs).
 Participating and contributing to the maintenance and calibration of analytical instruments within
 the quality control laboratories.
 Must be precise and consistent in day-to-day analysis, using sophisticated analytical instruments.
 Must be familiar with out of specification (OOS) and out of alert limit investigations.
 Must be able to execute compendial procedures involving complexity.
 Must be familiar with cGMP and OSHA regulations.
 Must be able to effectively communicate results, problems or issues, verbally as well as in writing.

 Performs Stability Testing using appropriate instrumentation. 
Required Qualifications
 3 to 5 years of relevant industry experience in analytical laboratories is required.
 FDA regulated environment working in QC laboratory is a plus. 
Physical Demands/Travel
 Provides feedback on systems and analytical procedures to promote continuous
improvement and enhancement of compliance posture.
    BS/BA degree in Chemistry required. MS or PhD in Chemistry is preferred.
  Experience with HPLC analytical testing, method development, and method validation is required.
 An excellent understanding and knowledge of analytical instrumentation technologies,
chromatography methods, ICH guidelines, and good manufacturing practices.
 Strong HPLC experience required with trouble shooting skills.
 A foundation in analytical technique, with hands-on sample preparation and operation of
analytical equipment and software is required.
 Experience with data analysis (MS Excel) and proficiency with MS Word is required.
 Experience with raw material, stability, in-process, and finished product testing is required.
 The physical demands of this job are consistent with a lab environment/ manufacturing
 environment.
 

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