QC Associate I/II/Sr at Abzena Inc. – Bristol, Pennsylvania

QC Associate I/II/Sr

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Quality Control Associate will be responsible for performing multiple tasks within the Quality Control (QC) group in support of large- and small-molecule GMP manufacturing activities. Focus areas include review, approval and execution of analytical method qualification/validation protocols and reports, routine support for raw material and product release and stability testing and documentation/data review of GMP analytical testing results. The position requires extensive experience within a GMP QC setting and detailed knowledge of GMP/GDP. The Senior associate will perform a variety of responsibilities in both a team and individual setting.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.

Qualifications

• 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.
• 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.
• Also preferred is 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.

FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.