AbbVie Principal Scientist I at AbbVie focusing on biologics drug product formulation and process development. Leads scale-up, tech transfer, and cross-functional collaboration in drug product development.
Responsibilities
Represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
Support scale-up and technology transfer activities to internal and external manufacturing sites.
Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
Qualification
BSPrincipal Scientist IExperience with biologics (proteinsKey Competencies
Required
BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with
Principal Scientist I: 14+ (Bachelors), 12+ (Masters), or 6+ (PhD) years of relevant industry experience.
Proven ability to solve critical scientific problems.
Experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product process development.
Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization), characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring.
Experience leading drug product development as the functional lead within cross-functional teams
Preferred
Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products
Understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products
Experience in managing third party manufacturers of sterile parenteral products
Experience with quality risk management and control strategies for biologics and sterile parenteral products
Key Competencies:
Deep scientific knowledge and significant hands-on experience with drug product process development and tech transfer
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.
