Abzena

CDMO for complex biologics and ADCs

Analytical Services Contractor

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBristol, PA, USANo salary listedIn-person

About the Job

Requirements

A bachelor's degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
At least 5 years of industry experience in analytical development or quality control within a regulated good manufacturing practice biopharmaceutical or pharmaceutical environment.
Strong working knowledge of separation-based analytical techniques, particularly high-performance liquid chromatography, gas chromatography, and capillary electrophoresis sodium dodecyl sulfate.
Demonstrated experience reviewing laboratory notebooks, technical reports, and good manufacturing practice documents.
Familiarity with method development and qualification principles.
Strong attention to detail and organizational skills, with the ability to manage multiple priorities.
Effective communication and collaboration skills for cross-functional teamwork.

Responsibilities

Review Analytical Development scientists' laboratory notebooks for completion and compliance with Good Documentation Practices, accuracy and clarity of data, and suitability of analytical methods and data to support development goals.
Provide technical support for separation-based assays, including high-performance liquid chromatography methods such as reversed-phase liquid chromatography, anion-exchange chromatography, cation-exchange chromatography, and hydrophobic interaction chromatography; gas chromatography; and capillary electrophoresis sodium dodecyl sulfate.
Review analytical methods and provide feedback to ensure compliance with internal standards and good manufacturing practice requirements.
Assess and review qualification protocols and reports for analytical methods being transferred to the quality control team for good manufacturing practice manufacturing support and release testing.
Support preparation and review of development reports.
Review and assist in generating Certificates of Testing for development batch release and stability time points.
Ensure data and documentation meet regulatory and internal compliance standards.

Desired Qualifications

Proficiency in document management systems.
Experience with stability testing and strong familiarity with International Council for Harmonisation guidelines, including Q1A–Q1E for stability, Q2(R2) for analytical method validation, and Q3A/B for impurities in drug substances and products.
Understanding of regulatory expectations for early-phase clinical development, including appropriate analytical data packages to support Investigational New Drug-enabling studies.
Prior experience supporting Investigational New Drug filings.
Familiarity with analytical data trending, specification setting, and interpretation of development and stability data in alignment with regulatory and internal standards.

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.

We are seeking a highly skilled and detail-oriented Analytical Services Contractor to support our Analytical Serviceswith documentation and data review activities. The ideal candidate will possess strong technical expertise in separation-based analytical techniques (e.g., HPLC, GC, CE-SDS) and have a solid understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

This individual will play a critical role in reviewing laboratory notebooks, ensuring data integrity, assessing suitability of the methods with AD management oversight, and supporting GMP-related documentation including method reviews, protocol/report reviews, and Certificates of Testing (CoT) for development batches.

Responsibilities

Review laboratory notebooks from Analytical Development scientists for:

Completion and compliance with GDP

Accuracy and clarity of data

Suitability of analytical methods and data to support development goals

Provide technical support for separation-based assays, including:

HPLC such as RPLC, AEX, CEX, HIC, etc.

CE-SDS

Review and provide feedback on analytical methods, ensuring compliance with internal standards and GMP requirements.

Assess and review qualification protocols and reports for analytical methods that are going to be transferred to quality control team for GMP manufacturing support and release testing.

Support preparation and review of development reports.

Review and assist in generation of Certificates of Testing (CoT) for development batch release and stability time points.

Ensure data and documentation meet all regulatory and internal compliance standards.

Qualifications

Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.

5+ years of industry experience in analytical development or quality control within a regulated (GMP) biopharmaceutical or pharmaceutical environment.

Strong working knowledge of separation-based analytical techniques, particularly HPLC, GC, and CE-SDS.

Demonstrated experience in reviewing laboratory notebooks, technical reports, and GMP documents.

Familiarity with method development and qualification principles.

Excellent attention to detail, strong organizational skills, and the ability to manage multiple priorities.

Effective communication and collaboration skills for cross-functional teamwork.

Proficiency in document management systems is a plus.

Preferred Skills:

Experience with stability testing and strong familiarity with ICH guidelines, including but not limited to: ICH Q1A–Q1E (Stability), ICH Q2(R2) (Analytical Method Validation), ICH Q3A/B (Impurities in Drug Substances and Products)

Solid understanding of regulatory expectations for early-phase clinical development, including appropriate analytical data packages to support IND-enabling studies.

Prior experience supporting IND filings is a plus.

Familiarity with analytical data trending, specification setting, and interpretation of development and stability data in alignment with regulatory and internal standards.

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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