Sr. Analytical Chemist

Mid-size family-owned manufacturer is looking for a Sr. Analytical Chemist with a background in strong method development and validation for mass spectroscopy and LC/MS.  If you have experience developing new methods and validating methods, this could be a great opportunity for you.  This role does require on site work Monday through Friday!  Company offers excellent benefits and great opportunities for growth.

The Analytical Senior Scientist will be responsible for the design and development of new analytical testing methodologies and the management of testing to support assigned development programs.  The Analytical Senior Scientist makes improvements to existing testing methodologies and processes.  Contributes tactically and strategically to the division.  The Analytical Senior Scientist coaches and mentors junior Associates. 

• Manage project testing support consistent with assigned development program requirements; contribute and represent Analytical R&D while serving on cross-functional teams chartered to develop and commercialize new drug delivery products; interact effectively fulfilling functional responsibilities, collaborating with functional counterparts & customers to assure overall project success
• Draft R&D stability protocols consistent with the stage of the project, for setting in-process and final product specifications (assay, impurity/related substances, dissolution, and residual solvents)
• Author method development protocols / reports and assist with method validation / verification / transfer to the Q.C. laboratory, as applicable
• Develop and troubleshoot stability-indicating methods for drug products
• Assist with the investigation of analytical testing results failures
• Design & conduct analytical testing on lab and production scale materials; draw valid conclusions upon analysis of technical data from experimental testing, expertise, and literature references
• Define test methodologies and requirements for specific analyte of interest; prepare test samples and conduct tests on in-process intermediates and/or finished products as required to support development programs; make improvements to existing testing methodologies as necessary to support development or product improvement projects
• Participate in the establishment of testing specifications and validation of testing methods thereof
• Transfer analytical methods to QC chemists
• Anticipate and proactively address potential lab method development, method validation, clinical, regulatory and commercial testing issues during development
• Support and contribute to maintaining office and laboratory environment consistent with LEAN 5S and all regulatory requirements
• Ensure up-to-date compliance with all training requirements; understands overall business strategy and plans while also working to execute responsibilities in accordance thereof
• Make identifiable and beneficial contributions to continuous improvement; perform all duties safely and consistent with established company and divisional procedures and guidelines; actively comply with and endorse department, divisional and company objectives
• Responsible for following all relevant regulations (e.g., DEA, FDA, OSHA, EPA, DEP, etc.) and company procedures

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Alicia Mytnik at amytnik@cps4jobs.com.

JO:  62.24AM
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Technical Qualifications:

• B.S. in chemistry or related field with a minimum of 10 years of method development experience
• 10+ years’ experience working with LC/MS analytical methods for analysis of transdermal and/or solid dosage form experience
• 7+ years’ experience in analytical method validation and pre-formulation analytical work in a pharmaceutical environment
• 7 years’ experience in an FDA regulated environment as well as familiarity with 21CFR Part 211 Federal regulations
• 5+ years’ experience in analytical group supporting development of ANDAs & NDAs
• Skilled technical writer and experience in writing analytical method development and validation reports
• Highly experience in FDA, USP and ICH guidances / monographs applicable to analytical testing

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Alicia Mytnik at amytnik@cps4jobs.com.

JO:  62.24AM
#LI-AM2