Senior Scientist I / II

AbbVie•North Chicago, IL

16h•Onsite

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’s R&D, is a global organization that is responsible for drug product formulation and process development, and definition of the product presentation for biologics and genetic medicine (proteins, conjugates, peptides etc.). AbbVie is seeking a highly motivated candidate for the position of Senior Scientist I, Biologics Drug Product Development, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics formulation and process development, and characterization. This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery research, analytical research and development, bioprocess development, combination products development, science and technology, pilot plants and third-party manufacturers.

Requirements

Proven ability to solve critical scientific problems.
Hands-on experience with biologics formulation development.
Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
Solid understanding of biologics degradation mechanisms and stabilization strategies.
Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.
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.
Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products
Experience leading drug product development as the functional lead within cross-functional teams

Nice To Haves

Understanding of relevant cGMP and regulatory guidance.
Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and lyophilization) development, characterization, scale-up and technology transfer.
Experience in managing third party manufacturers.
Experience with quality risk management and drug product control strategies.
Biologics drug product formulation development
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

Responsibilities

Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
Support scale-up and technology transfer activities to internal and external manufacturing sites.
Keep abreast of the latest advances in biologics formulation and process technologies.
Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and improve business processes.
May represent the Bio DPD function in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.
Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.