Associate Director Bioconjugation

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).