Principal Scientist, Bioconjugation

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 Bioconjugation Development Principal Scientist is responsible for leading bioconjugation efforts in discovery and process development to support Abzena Bristol's scientific and manufacturing operations. This includes conjugation screening, conjugation reaction optimization, 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

• Drive technical execution of R&D bioconjugation activities and successfully deliver client and internal company projects from initial assignment to completion.
• Hands-on execution of chromatographic purifications (affinity, hydrophobic interaction (HIC), and ion exchange chromatography (IEX)), membrane filtrations (normal and tangential flow filtrations (TFF)), buffer and solution preparation, conjugation reaction work-up.
• Perform, develop and optimize bioanalytical characterization (HPLC, UPLC, LC-MS, SEC-MALS, colorimetric assays, etc.) of conjugate products.
• Leverage expertise to aid in the design and management of project plans and conjugation strategies with a focus on improving project completion times.
• Serve independently as bioconjugation technical lead and subject-matter expert (SME) for internal and external project communications.
• Training, mentorship, and management of assigned reports.
• Monitor and assess direct report(s) performance through regular tracking of department based KPIs.
• SME and technical support for sales and proposals teams, including client facing scoping calls, bid defenses and proposal generation.
• Attendance and presenting 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.
• CoordinateactivitieswithQA/QCandManagement 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.

Qualifications

• A PhD in chemistry, bioorganic chemistry, or chemical biology with >5 years industry experience in biotherapeutic conjugate development or bioconjugation.
• Demonstrated experience applying and optimizing state-of-the-art bioconjugation or bioorthogonal chemistry techniques to produce conjugates (ADCs, AOCs/ARCs, PDCs, DACs, etc.) at various scales (mg-gram scales)
• Thorough, hands-on experience with small-scale and preparative chromatography systems(AKTA Pilot, AKTA Ready, AKTA Explorer, etc.) for purification of biomacromolecules (antibodies, fusion proteins, carrier proteins, viruses, viral vectors, or other biologics).
• Expertise in normal flow filtrations and tangential flow filtrations (TFF or UF/DF).
• Knowledge of strategies for the optimization of bioprocesses and experimental design (DoE).
• 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.
• 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.