Abzena

CDMO for complex biologics and ADCs

Senior Scientist - Separations

Bioprocess & BiomanufacturingPosted on Nov 10

Full-timeBristol, PA, USANo salary listedIn-person

About the Job

Requirements

A Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline with 5–8 years of industry experience, or an M.S. with 8–10+ years of relevant experience.
Extensive hands-on experience with LCUV characterization of biologics, ADCs, or related conjugated therapeutics.
Experience with analytical characterization techniques including RPLC/UV, SEC-UV, IEX-UV, and non-reduced/reduced cIEF.
Strong understanding of protein chemistry, conjugation technologies, and biopharmaceutical analytical development.
Experience with data analysis software such as Waters Empower or equivalent platforms.
Technical writing, problem-solving, and communication skills.

Responsibilities

Lead development, optimization, and transfer of chromatographic analytical methods supporting ADCs and related bioconjugate therapeutics.
Design and execute chromatographic studies for characterization of intact proteins/antibodies, fragment antibodies, small format proteins, peptides, linker-payloads, oligonucleotides, and conjugated species.
Perform characterization activities including DAR analysis, aggregation, fragmentation and charge variant assessment, free payload and linker impurity analysis, and stability studies.
Support analytical investigations related to process development, manufacturing deviations, comparability, and product quality assessments.
Collaborate with process development, bioassay, formulation, and quality teams to establish analytical control strategies and critical quality attributes (CQAs).
Develop robust sample preparation workflows for proteins, peptides, oligonucleotides, and conjugated modalities for chromatographic analyses.
Interpret complex analytical datasets and communicate findings to cross-functional project teams and client sponsors.
Author technical reports, analytical development summaries, regulatory documentation, SOPs, protocols, and method qualification reports.
Support regulatory submissions including IND, BLA, and IMPD analytical sections.
Maintain instrumentation, including general maintenance, troubleshooting, and scheduling preventive maintenance and vendor repair services.

Desired Qualifications

Experience specifically supporting ADCs, AOCs, radioconjugates, or oligonucleotide therapeutics.
Familiarity with linker-payload chemistry and conjugation process development.
Knowledge of regulatory expectations for biologics and conjugated therapeutics.
Experience supporting method qualification, validation, and comparability studies.
Demonstrated experience supporting CMC development and CGMP environments.
Prior experience working with CDMOs and external analytical laboratories.

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 an experienced separations scientist to develop methods for conjugate characterization activities supporting process development of antibody-drug conjugates (ADCs), oligonucleotide conjugates, radioconjugates, and other complex bioconjugate modalities. This individual will serve as a technical expert in separations-based characterization and method development across process development and CMC activities

The successful candidate will play a key role in developing and implementing advanced chromatographic workflows for structural characterization, impurity analysis, linker-payload assessment, DAR determination, and comparability studies to support clinical development programs.

Responsibilities

Lead development, optimization, and transfer of chromatographic analytical methods supporting ADCs and related bioconjugate therapeutics.
Design and execute chromatographic studies for characterization of intact proteins/antibodies, fragment antibodies, small format proteins, peptides, linker-payloads, oligonucleotides, and conjugated species.
Perform characterization activities including DAR analysis, aggregation, fragmentation and charge variant assessment, free payload and linker impurity analysis, and stability studies.
Support analytical investigations related to process development, manufacturing deviations, comparability, and product quality assessments.
Collaborate closely with process development, bioassay, formulation, and quality teams to establish analytical control strategies and critical quality attributes (CQAs).
Develop robust sample preparation workflows for proteins, peptides, oligonucleotides, and conjugated modalities for chromatographic analyses.
Interpret complex analytical datasets and communicate findings to cross-functional project teams and client sponsors.
Author technical reports, analytical development summaries, regulatory documentation, SOPs, protocols, and method qualification reports.
Support regulatory submissions including IND, BLA, and IMPD analytical sections.
Maintain instrumentation including general maintenance, troubleshooting and scheduling of performative maintenance and vendor repair services.

Qualifications

Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 5-8 years of industry experience; or M.S. with 8-10+ years of relevant experience
Extensive hands-on experience with LCUV characterization of biologics, ADCs, or related conjugated therapeutics.
Experience with analytical characterization techniques including RPLC/UV, SEC-UV, IEX-UV, non-reduced/reduced cIEF.
Strong understanding of protein chemistry, conjugation technologies, and biopharmaceutical analytical development.
Experience with data analysis software such as Waters Empower or equivalent platforms.
Excellent technical writing, problem-solving, and communication skills.

Preferred Qualifications:

Experience specifically supporting ADCs, AOCs, radioconjugates, or oligonucleotide therapeutics.
Familiarity with linker-payload chemistry and conjugation process development.
Knowledge of regulatory expectations for biologics and conjugated therapeutics.
Experience supporting method qualification, validation, and comparability studies.
Demonstrated experience supporting CMC development and CGMP environments.
Prior experience working with CDMOs and external analytical laboratories.

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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