Associate Principal Scientist

Abzena Inc. • Bristol, PA

5d • Hybrid

About The Position

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.

Requirements

• A PhD in chemistry, bioorganic chemistry, chemical biology or similar with >7 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).
• Prior leadership experience required.
• Travel between Abzena sites (Bristol PA, San Diego CA, Cambridge UK) as needed.

Responsibilities

• Drive and support 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.
• Help 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree