AbbVie's Biologics Drug Product Development (Bio DPD) is seeking an accomplished scientist to lead the formulation and process development for biologics and genetic medicines, aiming to solve serious health issues through innovative drug delivery.
Requirements
- Experience with biologics (proteins, conjugates, peptides and/or neurotoxins) and/or genetic medicine (AAV, LNPs, cell therapy) formulation and process development.
- Experience with lyophilization process design, characterization, scale-up, modeling and technology transfer.
- Experience with different solid-state characterization methods.
- Understanding of relevant cGMP and regulatory guidance.
- Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling) development, characterization, scale-up and technology transfer.
- Experience in managing third party manufacturers.
- Experience with quality risk management and drug product control strategies.
Responsibilities
- Serve as subject matter expert in lyophilization process development, characterization and troubleshooting, and soli-state characterization.
- Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
- Lead scale-up and technology transfer activities of bioproducts to internal and external manufacturing sites.
- Keep abreast of the latest advances in biologics formulation, lyophilization and alternative drying technologies.
- Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
- Lead matrix drug product teams for one or more projects and represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
- May supervise and/or mentor junior level scientists and engineers.
Other
- Proven ability to solve critical scientific problems.
- Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
- People management experience.
- Effectively communicates to influence without authority, drives technical excellence, and inspires continuous improvement.
- Builds strong relationships with peers and cross-functional partners to enable higher performance.
