Bioconjugation Development Leader

Abzena; Bristol Township (Bucks County); On-site; USD 170,000 - 250,000; Full time

Job summary

Abzena is seeking an Associate Director of Bioconjugation Development to lead discovery and development activities supporting Bristol’s development and manufacturing operations. Responsibilities include conjugation development, downstream purification development and scale-up, mentorship of direct reports, and client-facing meetings.

The role also supports sales/proposals with SME input, drives project planning, and ensures compliance with ICH and FDA guidelines during tech transfer and batch

Qualifications

• PhD or BS/MS in biochemical sciences or bio-engineering with industry experience (>3 years for PhD, >6 years for 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).
• Hands-on experience with preparative chromatography systems (AKTA Pilot, AKTA Ready, AKTA Explorer, etc.), and manual or automated TFF skids.

Responsibilities

• Oversee the Bioconjugation Development department operations and plan resources to 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 SME for internal and external project communications.
• Training, mentorship, and management of assigned reports.
• Monitor and assess team member performance through KPI tracking.
• SME and technical support of sales and proposals team including client facing scoping calls, bid defenses and proposal generation.
• 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 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.
• 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.

Skills

Bioconjugation development

Leadership/mentorship

Client communication

DoE design of experiments

cGMP knowledge

Education

Biochemical sciences or bio-engineering degree

Tools

AKTA chromatography systems

TFF skids

HPLC/UPLC/LC-MS instrumentation

Job description

Abzena is seeking an Associate Director of Bioconjugation Development to lead discovery and development activities supporting Bristol’s development and manufacturing operations. Responsibilities include conjugation development, downstream purification development and scale-up, mentorship of direct reports, and client-facing meetings.

The role also supports sales/proposals with SME input, drives project planning, and ensures compliance with ICH and FDA guidelines during tech transfer and batch