Associate Director, Bioconjugation

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 170,000 - 210,000; Full time

Job summary

Abzena is seeking an Associate Director Bioconjugation Development to lead bioconjugation discovery and development activities at Abzena Bristol. You will oversee conjugation development, downstream purification, and scale-up to support client and internal programs.

The role involves mentoring staff, leading client meetings, contributing to proposals, and ensuring cGMP compliance while advancing technology through transfer to manufacturing teams.

Qualifications

• PhD or MS/BS in biochemical sciences or bio-engineering with industry experience in biotherapeutic development or bioconjugation.
• Experience in preparative purification of biological molecules.
• Knowledge of chromatography systems and tangential flow filtration (TFF).

Responsibilities

• Oversee Bioconjugation Development department operations and resource planning to deliver client and company projects.
• Hands-on execution of chromatographic purifications, membrane filtrations, and conjugation work-up.
• Perform and optimize bioanalytical characterization of bioconjugate products.
• Project planning and management
• Serve as bioconjugation technical lead for internal and external communications.
• Mentorship, training and management of assigned reports.
• Coordinate with QA/QC and Management for tox and GLP batch development.

Skills

Bioconjugation development

Team leadership

Client-facing communication

Project planning

Education

PhD or MS/BS in biochemical sciences or bio-engineering

Tools

AKTA systems

HPLC/LC-MS

TFF systems

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 Director Bioconjugation Development is responsible for leading bioconjugation discovery and development activities to support Abzena Bristol’s development and manufacturing operations. This includes conjugation development, downstream purification development and scale-up activities; mentorship, training and management of direct reports; lead client facing meetings and updates; support sales and proposals process by providing technical and SME support including the design and costing of project activities.

Responsibilities

• Oversee the Bioconjugation Development department operations and plan resources to successfully deliver client and company projects from project assignment to completion.
• Hands-on execution of chromatographic purifications (affinity, hydrophobic interaction, and ion exchange chromatography), membrane filtrations (normal and tangential flow filtrations), buffer and solution preparation, conjugation reaction work-up.
• Perform, develop and optimize bioanalytical characterization (HPLC, UPLC, LC-MS, MALDI, MALS, colorimetric assays, etc.) of bioconjugate products.
• Project planning and management
• Serve independently as bioconjugation technical lead and subject-matter expert for internal and external project communications.
• Training, mentorship, and management of assigned reports.
• Monitor and assess team member performance through regular tracking of department based KPIs.
• SME and technical support of sales and proposals team including client facing scoping calls, bid defenses and proposal generation.
• Attendance and participation at scientific and business conferences.
• Lead technical transfer of bioconjugation processes to Abzena’s bioconjugation manufacturing group including training, risk assessment, gap assessments and batch record writing and review according to ICH and FDA guidelines.
• Authoring and reviewing relevant documentation including laboratory notebooks, process development reports, protocols, batch records, SOPs, technical presentations.
• Provide on the floor SME and technical support during complex manufacturing operations as needed.
• Coordinate activities with QA/QC and Management for development of tox and GLP batches.
• Maintain strong technical understanding of advancements in bioconjugation/bioprocessing through literature searches and review.
• Participate in the hiring process by screening and interviewing candidates.
• Operate to the highest ethical and moral standards.
• Comply with Abzena's policies and procedures.
• Communicate effectively with clients, supervisors, colleagues and staff.
• Participate effectively as a team player in all aspects of Abzena's business.
• Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
• Perform other duties as assigned.
• Contribute to assigned laboratory operations including instrument and equipment operations, material shipment preparation, consumables procurement.

Qualifications

• A PhD or BS/MS degree in biochemical sciences or bio-engineering with industry experience (>3 year + PhD, > 6 years + MS/BS) in biotherapeutic development or bioconjugation.
• Experience in preparative purification of biological molecules (antibodies, carrier proteins, viruses, viral vectors, or other biological molecules).
• Expertise in normal flow filtrations and tangential flow filtrations (TFF, UF/DF).
• Knowledge of strategies for the optimization of bioprocesses and experimental design (DoE).
• Thorough hands-on experience with preparative chromatography systems (AKTA Pilot, AKTA Ready, AKTA Explorer, etc.), and manual or automated TFF skids.
• Expertise with quantitative determination of scalable process parameters for normal flow filtrations, tangential flow filtrations, and preparative chromatographic separations.
• Knowledge of cGMP manufacturing operations and GxP principles.
• Strong knowledge of bioconjugation reactions, techniques and approaches.
• Experience with protein bioanalytical techniques (HPLC, LC-MS, CE-SDS, UV-spectrophotometry, etc.)
• Experience with large scale bioprocess equipment (pallet tanks, pumps, biowelders, biosealers, bio-rockers, single-use assemblies).

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.