QC Associate II

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 52,000 - 75,000; Full time

Job summary

Abzena is seeking an Associate II to provide hands-on laboratory support for analytical method development, qualification, and routine testing within our GMP environment. You will advance from Associate I, taking on defined tasks with growing independence and contributing to data analysis and documentation.

Based in our Bucks County, PA facility, the role requires diligence with HPLC, CE, GC and other assays, adherence to SOPs and GMP practices, and collaboration with scientists to drive quality

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.

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; elevate 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.

Education

Bachelor's degree in Chemistry, Biochemistry, or a related scientific field

Tools

HPLC

CE

GC

Compendial testing

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.

The Associate II provides hands-on laboratory support for analytical method development, qualification, and routine testing activities. This role builds on foundational laboratory skills gained as an Associate I, taking on increasing independence for defined tasks and beginning to contribute to data analysis and documentation with reduced oversight.

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; elevate 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.