QC Scientist II/III

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 90,000 - 130,000; Full time

Job summary

Abzena Inc. in the United States seeks an experienced Scientist III to independently execute complex analytical method development, qualification, and testing activities.

This role significantly contributes to technical problem-solving and provides mentorship to junior team members. The position involves leading method qualification, authoring protocols, and supporting GMP records while collaborating across teams to deliver high-quality results for biologics and bioconjugates from discovery to

Qualifications

• Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, or related field.
• 5–7+ years of experience in analytical method development and testing.
• Strong background in the assigned platform(s) (HPLC, CE, GC, or compendial assays).
• Experience working in a GMP environment; track record of independently leading method development or qualification activities.
• Stability testing: Independently executes stability timepoints according to approved protocols and testing windows, confirms sample and method readiness, reviews data for consistency/trends, and promptly escalates atypical or potentially reportable results.
• Method lifecycle and investigations: Leads defined qualification activities, authors protocols/reports and test methods, supports transfers and method changes, and provides substantive technical input to OOS/Laboratory Investigations and CAPAs.

Responsibilities

• Independently design and execute complex analytical methods within the assigned platform(s).
• Lead method qualification activities and prepare qualification protocols and reports.
• Perform routine and non-routine analytical testing in support of ongoing projects; analyze, interpret, and present data.
• Author and review SOPs, test methods, and technical/qualification documentation; maintain accurate GMP records.
• Support OOS investigations and contribute to CAPA implementation.
• Provide guidance and mentorship to Scientist I/II and Associate staff; collaborate cross-functionally and communicate technical updates.
• Independently perform and coordinate routine/non-routine GMP and stability testing; verify method, sample, and instrument readiness and escalates atypical results or testing-window risks.

Skills

Analytical method dev

GMP testing

Data analysis

Mentorship

Cross-functional collab

Education

Bachelor's degree in Analytical Chemistry, Biochemistry, or related field

Master's degree in Analytical Chemistry or related field

Tools

HPLC

CE

GC

Compendial assays

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 Scientist III is an experienced analytical scientist who independently executes complex method development, qualification, and analytical testing activities. This role contributes significantly to technical problem-solving and provides mentorship to junior team members.

Responsibilities

• Independently design and execute complex analytical methods within the assigned platform(s).
• Lead method qualification activities and prepare qualification protocols and reports.
• Perform routine and non-routine analytical testing in support of ongoing projects; analyze, interpret, and present data.
• Author and review SOPs, test methods, and technical/qualification documentation; maintain accurate GMP records.
• Support OOS investigations and contribute to CAPA implementation.
• Provide guidance and mentorship to Scientist I/II and Associate staff; collaborate cross-functionally and communicate technical updates.
• Independently perform and coordinate routine/non-routine GMP and stability testing; verify method, sample, and instrument readiness and escalates atypical results or testing-window risks.

Qualifications

• Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, or related field.
• 5–7+ years of experience in analytical method development and testing.
• Strong background in the assigned platform(s) (HPLC, CE, GC, or compendial assays).
• Experience working in a GMP environment; track record of independently leading method development or qualification activities.
• Stability testing: Independently executes stability timepoints according to approved protocols and testing windows, confirms sample and method readiness, reviews data for consistency/trends, and promptly escalates atypical or potentially reportable results.
• Method lifecycle and investigations: Leads defined qualification activities, authors protocols/reports and test methods, supports transfers and method changes, and provides substantive technical input to OOS/Laboratory Investigations and CAPAs.

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.