QC Associate II

Abzena; Bristol Township (Bucks County); On-site; USD 45,000 - 70,000; Full time

Job summary

Abzena is seeking an entry- to mid-level Analytical Scientist to perform routine and development-phase testing, and support method development programs. The role requires familiarity with HPLC, CE, GC, and GMP documentation practices, with 0–5+ years of lab experience.

Ideal candidates hold a Bachelor's in Chemistry or Biochemistry and will work under GMP guidelines in a fast-paced environment, contributing to quality and timely delivery of projects.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, or related field or equivalent hands-on lab experience.
• 0-5+ years of relevant lab experience (internships included).
• Familiarity with one or more analytical platforms (HPLC, CE, GC, or compendial testing).
• Working knowledge of GMP documentation practices.

Responsibilities

• Perform routine and development-phase analytical testing under guidance.
• Prepare samples, reagents, standards, and solutions per SOPs.
• Operate, maintain, and troubleshoot laboratory instrumentation; escalate issues as needed.
• Record data accurately and maintain notebooks/records per GMP.
• Contribute to method development experiments and qualification activities as directed by Scientist or Sr. Scientist staff.
• Support OOS investigations by providing data, sample history, or technical input as requested.
• Participate in team meetings, training sessions, and continuous improvement discussions.
• Perform routine GMP and stability testing after documented training/qualification, with general guidance.

Skills

HPLC

CE

GC

GMP docs

Lab data management

Education

Bachelor's degree in Chemistry or Biochemistry

Tools

HPLC systems

CE/GC instruments

Lab equipment

Job description

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.

Responsibilities

• Perform routine and development-phase analytical testing (e.g., HPLC, CE, GC, or compendial assays) under general guidance.
• Prepare samples, reagents, standards, and solutions accurately and in accordance with SOPs.
• Operate, maintain, and perform basic troubleshooting of laboratory instrumentation; escalated issues as needed.
• Record data accurately and maintain laboratory notebooks/records in compliance with GMP and good documentation practices.
• Contribute to method development experiments and qualification activities as directed by Scientist or Sr. Scientist staff.
• Support OOS investigations by providing data, sample history, or technical input as requested.
• Participate in team meetings, training sessions, and continuous improvement discussions.
• Perform routine GMP and stability testing after documented training/qualification, with general guidance and strict adherence to approved methods, specifications, and sample/timepoint requirements.
• Platform proficiency: Working proficiency in routine execution of one or more assigned platforms after documented training; performs defined testing with general guidance and increasing independence.
• Stability testing: Supports routine stability testing by ensuring correct sample/timepoint handling, timely execution, traceable documentation, and escalation of sample, scheduling, or result concerns.
• Method lifecycle and investigations: Supports development/qualification experiments and investigation activities through accurate execution, data capture, sample history retrieval, and documentation under scientist guidance.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, or a related scientific field (or equivalent hands-on laboratory experience).
• 0-5+ years of relevant laboratory experience (including internships/co-ops).
• Familiarity with one or more analytical platforms (HPLC, CE, GC, or compendial/physicochemical testing).
• Working knowledge of GMP documentation practices.

FLSA: Non-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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgement. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.