Principal Scientist – Bioconjugation
| Company | Abzena |
|---|---|
| Location | Bristol, PA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | PhD |
| Experience Level | Senior |
Requirements
- 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).
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.
- 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.
Preferred Qualifications
-
No preferred qualifications provided.