Abzena · 1 day ago
QC Associate I/II/Sr
Bristol, PA
Full-time
Onsite
Entry, Mid, Senior Level
3+ years expAbzena is a company dedicated to quality excellence in the development of biologics and bioconjugates. The Quality Control Associate will be responsible for performing multiple tasks within the Quality Control group to support GMP manufacturing activities, including analytical method qualification and validation, product release testing, and documentation review.
BiopharmaBiotechnologyLife SciencePharmaceutical
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
Qualification
Required
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
Preferred
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
Company
Abzena
Abzena is a biotechnology company that offers biologic and ADC products from concept to clinic.
501-1000 employees
H1B Sponsorship
Abzena has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$139.44MKey Investors
Biospring PartnersProVen VCT
2022-03-31Private Equity· $65M
2020-07-28Private Equity· $10M
2018-08-16Acquired
Leadership Team
Geoffrey Glass
Chief Executive Officer
Daniel Giroux
Vice President, Development
Recent News
Genetic Engineering News
2025-11-08
2025-10-24
Company data provided by crunchbase