Sr QC Associate – Analytical

Sr QC Associate – Analytical

Requirements

• B.S. in a scientific field with 5 – 7 years’ or Ph. D. in a scientific field with 3 – 5 years’ experience working in QC analytical laboratory supporting GMP manufacturing is required.
• Expertise with theoretical, practical and compliance aspects of GMP analytical testing utilized for release and stability testing of small and large molecule therapeutics including GC, U/HPLC, CE SDS, cIEF, and ELISA is required, as well as familiarity with submission-quality documentation of test results.
• Experience with analytical technical transfer and qualification/validation of analytical methods used for testing small and large molecule process intermediate, release and stability samples is required.
• Experience with authoring, reviewing and approving analytical test methods, qualification/validation protocols and reports and SOPs supporting QC laboratory operations is required.
• Strong technical writing, review and oral communication skills and proficiency with Microsoft Office software is required.

Responsibilities

• Provides critical QC technical review of analytical test methods and method qualification/validation protocols and reports.
• Leads the execution of analytical method qualification/validation protocols and authors technically sound method qualification/validation reports.
• Performs in-process, release and stability testing via small molecule (i.e. GC, KF, etc.) and bioanalytical techniques (i.e. U/HPLC, CE-SDS, icIEF, etc.) to support internal bulk drug substance manufacturing and third-party drug product processes.
• As a technical subject matter expert, perform peer review and release of internal and contract laboratory analytical data. Provide guidance and mentorship to junior associates that is aligned with laboratory leadership.
• Lead laboratory investigations to determine root cause for OOS, OOT, atypical and invalid test results.
• Contributes to laboratory operations by performing regular instrument calibration and minor instrument maintenance.
• Leads the implementation of programs (e.g. evaluation/implementation of compendial testing).
• Support operational systems (e.g. equipment maintenance, reagent preparation, forms control, etc.).
• May provide limited analytical testing and data review support for QC raw material wet chemistry testing (i.e. Raman spectroscopy, GC, TOC, Conductivity, FTIR, KF, etc.).
• Perform all duties while adhering to the highest ethical and moral standards and in compliance with Abzena’s policies and procedures. Adhere to quality standards set by regulatory guidance, industry standards and Abzena policies, procedures, and mission statement.
• Communicate effectively with clients, line management, colleagues and staff. Work effectively as part of a team in all aspects of executing responsibilities.
• Perform other related duties as assigned.

Preferred Qualifications

• Experience with analytical methods utilized in testing samples obtained through execution of the Environmental Monitoring program, including analysis of viable and non-viable air and surface samples, Bioburden and Endotoxin is a plus.
• Detailed knowledge of compendial (USP, Ph. EUR, JP, etc.) wet chemistry testing and ICH guidelines, experience with generation and monitoring trend data and control charts is a plus.