Abzena

CDMO for complex biologics and ADCs

QC Scientist 2/3

Regulatory & Quality (Life Sciences)Posted on Nov 12

Full-timeBristol, PA, USANo salary listedIn-person

About the Job

Requirements

A bachelor's or master's degree in Analytical Chemistry, Biochemistry, or a related field.
Five to seven or more years of experience in analytical method development and testing.
A strong background in assigned platforms, including HPLC, CE, GC, or compendial assays.
Experience working in a GMP environment and a track record of independently leading method development or qualification activities.
Ability to independently execute stability timepoints according to approved protocols and testing windows, confirm sample and method readiness, review data for consistency and trends, and promptly escalate atypical or potentially reportable results.
Ability to lead defined qualification activities, author protocols, reports, and test methods, support method transfers and changes, and provide substantive technical input to OOS/Laboratory Investigations and CAPAs.

Responsibilities

Independently design and execute complex analytical methods within assigned platforms.
Lead method qualification activities and prepare qualification protocols and reports.
Perform routine and non-routine analytical testing for ongoing projects; analyze, interpret, and present data.
Author and review SOPs, test methods, and technical or qualification documentation, and 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 and non-routine GMP and stability testing; verify method, sample, and instrument readiness; and escalate atypical results or testing-window risks.

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 escalate 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.

About the Company

Abzena

CDMO for complex biologics and ADCs

Abzena is a contract development and manufacturing organization (CDMO) that provides integrated services for complex biologics and bioconjugates, including antibody-drug conjugates, from discovery through GMP manufacturing for clinical trials and commercial supply. Its offerings cover antibody discovery, protein engineering, cell line development, process and analytical development, and cGMP manufacturing, often using its proprietary ThioBridge and Composite Human Antibody platforms. Abzena differentiates itself by delivering end-to-end development and manufacturing for complex biologics and by leveraging its proprietary technologies, with global facilities in the US and UK and a history of strategic acquisitions. Its goal is to help biotech and pharma programs progress efficiently from research to commercial supply by providing integrated services and potential licensing opportunities.

Company size: 201-500
Company stage: IPO
Headquarters: Babraham, United Kingdom
Founded: 2001

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