Abzena plc

Sr QC Associate, Analytical

Abzena plc • $75K — $95K *
Bristol, PA 19007In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
4 weeks ago
Job Overview by Ladders

Qualifications

  • B.S. in a scientific field with 5-7 years or Ph.D. with 3-5 years of QC experience in GMP manufacturing.
  • Extensive expertise in GMP analytical testing for small and large molecule therapeutics, including GC, U/HPLC, and ELISA.
  • Proven experience in analytical method qualification, validation, and technical transfer.
  • Strong skills in authoring and reviewing analytical methods and quality documentation.
  • Excellent communication skills and proficiency in Microsoft Office.
  • Familiarity with environmental monitoring analytical methods is a plus.
  • Knowledge of compendial testing and trend data generation is preferred.

Responsibilities

  • Conduct critical QC technical reviews of analytical test methods and reports.
  • Lead and execute analytical method qualification protocols and write detailed reports.
  • Perform in-process, release, and stability testing using a range of analytical techniques.
  • Mentor junior associates and perform peer reviews of laboratory data.
  • Investigate laboratory out-of-specification results and lead corrective actions.
  • Ensure instrument calibration and carry out basic maintenance tasks.
  • Implement compendial testing programs and support operational systems.

Benefits

  • Flexible work schedule with weekend availability required.
  • Opportunity for mentorship and growth within a collaborative team environment.
Full Job Description
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.

Weekend work required, schedule is flexible.

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

About Abzena plc

Abzena is a life sciences group with headquarters in Cambridge, UK and offices in the US and Japan. The company provides technologies and complementary services to enable the development and manufacture of biopharmaceutical products. Abzena's services and technologies are used by a range of companies and academic organisations across the pharmaceutical industry, including small biotech to large pharmaceutical companies. The company's proprietary technologies include composite human antibodies and site-specific conjugation technologies, which enable the development of antibody drug conjugates (ADCs) and other biotherapeutics. Abzena's services include antibody discovery and engineering, immunology services, bioassays, cell line development, and biomanufacturing. The company has a range of partnerships and collaborations with pharmaceutical companies and academic institutions, and has a number of products in clinical development.
Learn more about Abzena plc
Size
200 employees
Industry
Pharmaceuticals & Biotech
Founded
2014
Revenue
$17 million
NASDAQ
ABZA
* Ladders Estimates

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